US Market News
4日前
IDEAYA Biosciences Announces Clinical Collaboration with Roche in MTAP-Deleted RAS-Mutant Pancreatic CancerJune 3, 2026 6:00 AM
PR Newswire (US) IDEAYA entered into a clinical collaboration with Roche to evaluate IDE892, IDEAYA's potential best-in-class Phase 1 MTA-cooperative PRMT5 inhibitor, in combination with RG6505, Roche's Phase 1 pan-RAS inhibitor, in MTAP-deleted, RAS-mutant pancreatic ductal adenocarcinomaIDEAYA will sponsor the clinical trial, and there will be joint IDEAYA and Roche governance to oversee the studyMTAP-deletion is estimated to occur in up to 40% of PDACSOUTH SAN FRANCISCO, Calif., June 3, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced it has entered into a clinical collaboration with Roche to evaluate the efficacy and safety of IDE892, its investigational, potential best-in-class PRMT5 inhibitor, in combination with Roche's RG6505, a pan-RAS inhibitor, in patients with pancreatic ductal adenocarcinoma (PDAC) that carry an MTAP deletion. IDEAYA will sponsor the clinical trial combination study, and Roche will supply RG6505. "We are pleased to evaluate the clinical combination of IDE892 with RG6505 in MTAP-deleted RAS-mutant PDAC," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. "This collaboration aligns with our broader clinical strategy to evaluate rational combinations with assets in our MTAP-deletion portfolio, and there remains especially high unmet need in PDAC." IDE892 was designed to be a potential best-in-class PRMT5 inhibitor and has demonstrated robust monotherapy regressions in MTAP-deleted preclinical models. IDEAYA is evaluating IDE892 in a Phase 1 dose escalation clinical trial in MTAP-deleted solid tumors and plans to initiate Phase 1 combination cohorts, in PDAC with RG6505 as well as in NSCLC and other solid tumors with IDE397, IDEAYA's proprietary MAT2A inhibitor.MTAP deletion is estimated to occur in up to 40% of PDAC and almost all MTAP-deleted PDAC harbor co-occurring RAS mutations. Combining a PRMT5 inhibitor with a pan-RAS inhibitor may have the potential to drive deeper and more durable responses for MTAP-deleted PDAC patients who currently have no approved targeted treatment options. Under the clinical collaboration, IDEAYA and Roche each retain all commercial rights to their respective compounds, including as monotherapy and as combination therapies. There will be joint IDEAYA and Roche governance to oversee the clinical combination study. The clinical collaboration also has the ability to evaluate a combination triplet with IDE892, RG6505, and IDE397, IDEAYA's Phase 2 MAT2A inhibitor, upon joint IDEAYA and Roche approval.About IDEAYA BiosciencesIDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the potential therapeutic benefit, safety, and efficacy of IDE892, alone or in combination with RG6505; the planned clinical development, including the initiation, timing, progress, and design of clinical trials evaluating IDE892 in combination with RG6505 and other agents; the potential for IDE892 to be a best-in-class PRMT5 inhibitor; the potential for combination therapies targeting MTAP-deleted and RAS-mutant tumors to drive deeper or more durable responses; the estimated prevalence of MTAP deletions in PDAC; the potential benefits of the clinical collaboration with Roche; and IDEAYA's broader clinical and strategic plans, including the development of its MTAP-deletion portfolio. Such forward-looking statements are based on IDEAYA's current expectations and beliefs and involve substantial risks and uncertainties that could cause actual results to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, but are not limited to: risks related to the success, cost, and timing of IDEAYA's product candidate development activities and clinical trials; the risk that results from preclinical studies or early clinical trials may not be predictive of future clinical results; risks related to the development and regulatory approval of drug candidates; risks related to IDEAYA's dependence on third parties, including Roche, for collaboration activities and clinical supply; risks related to the ability to successfully enroll patients in clinical trials; and risks related to the potential for adverse safety events or lack of efficacy. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed or implied by the from these forward-looking statements, as well as risks relating to the business of the Company in general, see the Company's Annual Report on Form 10-K dated February 17, 2026, and any current and periodic reports filed or furnished with the Securities and Exchange Commission.Investor and Media ContactIDEAYA Biosciences
Joshua Bleharski, Ph.D.
Chief Financial Officer
investor@ideayabio.com View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-clinical-collaboration-with-roche-in-mtap-deleted-ras-mutant-pancreatic-cancer-302789169.htmlSOURCE IDEAYA Biosciences, Inc. Original: IDEAYA Biosciences Announces Clinical Collaboration with Roche in MTAP-Deleted RAS-Mutant Pancreatic Cancer
US Market News
3週前
B7-H3 Becomes The Hottest Antigen In Oncology, And One NK Engager Enters ClinicMay 18, 2026 2:22 PM
PR Newswire (US) Issued on behalf of GT Biopharma, Inc. SAN FRANCISCO, May 18, 2026 /PRNewswire/ -- USA News Group News Commentary — For more than two decades, B7-H3 sat on the shortlist of theoretically perfect cancer drug targets that nobody could quite figure out how to hit. The protein is broadly overexpressed across some of the most common — and most lethal — solid tumors, including prostate, lung, breast, ovarian, head and neck, and pancreatic cancers. It is largely absent from healthy tissue. It correlates with poor prognosis. On paper, it has every quality a drug developer wants. In practice, three B7-H3-targeting antibody-drug conjugates have entered the clinic, and none have yet been approved.[1] That is starting to change. Key Takeaways GT Biopharma (NASDAQ: GTBP) dosed the first patient on May 14, 2026 in a Phase 1 dose-escalation basket trial of GTB-5550, its B7-H3-targeted natural killer cell engager for solid tumors expressing B7-H3 — the third TriKE candidate to enter the clinic, and the first tested with patient-friendly subcutaneous dosing.FDA cleared the GTB-5550 IND in February 2026, with dose-escalation cohorts prioritizing advanced prostate, ovarian, and pancreatic cancer patients who have failed prior therapy. The Company targets a portion of the estimated US$362 billion global solid tumor market.B7-H3 has rapidly become one of the most actively pursued antigens in solid tumor oncology in 2026, with bispecific antibody-drug conjugates, systemic radiopharmaceuticals, and now natural killer cell engagers all converging on the same target — broadly overexpressed across prostate, lung, breast, ovarian, head and neck, and pancreatic cancers, largely absent from healthy tissue.GT Biopharma reported a cash balance as of March 31, 2026 of approximately US$9 million, anticipated to provide sufficient cash runway through Q4 2026, with Phase 1 updates anticipated in 2H 2026 as dose escalation progresses.In 2026, B7-H3 has become one of the most actively pursued antigens in solid tumor oncology. The mechanisms are widely varied — bispecific antibody-drug conjugates at IDEAYA, antibody-drug conjugates at GSK paired with bispecific antibody combinations at Summit Therapeutics, systemic radiopharmaceuticals across other pipelines, and now a natural killer cell engager from GT Biopharma, Inc. (NASDAQ: GTBP) — but the target is the same. The convergence is what makes the moment distinctive. When mechanism diversity collapses onto a single antigen, the antigen is what is being repriced.Read more on GT Biopharma by clicking here GTB-5550: The Third TriKE Into The Clinic, And The First Subcutaneous On May 14, 2026, GT Biopharma announced that the first patient had been dosed in a Phase 1 dose-escalation basket trial evaluating GTB-5550, its B7-H3-targeted natural killer cell engager for solid tumors expressing B7-H3.[2] GTB-5550 is the third TriKE — Tri-specific Killer Engager — molecule from GT Biopharma to enter the clinic. Critically, it is also the first to be tested with subcutaneous dosing, a design choice that distinguishes it from a category where most engager therapies have historically required continuous infusion.[1]"Dosing the first patient in our GTB-5550 Phase 1 trial is a pivotal milestone for GT Biopharma and represents the natural evolution of our TriKE platform into the broader opportunity of treating patients with a variety of solid tumors," said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma.[1] The May 15, 2026 Q1 financial results release confirmed the broader pipeline context: with the GTB-5550 Phase 1 trial now active, GT Biopharma has advanced three TriKE candidates into the clinic — a milestone Breen described as one that "underscores the continued momentum of our pipeline."[3]The molecular architecture of GTB-5550 reflects the design discipline GT Biopharma has built into its 2nd-generation TriKE platform. The molecule is a camelid (cam) anti-CD16 / WT IL-15 / cam anti-B7-H3 tri-specific natural killer cell engager — a single-chain recombinant TriKE comprised of three components joined by flexible linkers: a nanobody arm that engages the CD16 activating receptor on natural killer cells, a wildtype IL-15 linker arm to drive NK cell proliferation, priming, and survival, and a nanobody arm that specifically engages B7-H3 to target the antigen expressed on tumor cells.[4] The 2nd-generation TriKE platform that underlies GTB-5550 has been described as 10–40 times more potent than 1st-generation TriKE, and all current TriKE development at the Company is focused on the 2nd-generation platform.[4]Dose Escalation: Prostate, Ovarian, And Pancreatic Cancer Prioritized FDA cleared the GTB-5550 IND application in February 2026.[5] In the Company's commentary on the clearance, Breen described it as "a defining moment for GT Biopharma as we bring another NK cell engager into the clinic."[5] The Phase 1 trial is structured as a basket trial open to patients with common solid tumors that express B7-H3. In the dose-escalation component, enrollment is being prioritized for advanced prostate, ovarian, and pancreatic cancer patients who have failed prior therapy.[5] The clinical design reflects a deliberate choice: prioritize patient populations where the unmet need is highest, where B7-H3 expression is well-characterized, and where the regulatory pathway around accelerated approval has historically been most navigable.Phase 1 trial updates are anticipated in the second half of 2026 as enrollment progresses through dose escalation cohorts.[3] The Q1 2026 financial results release reported a cash balance as of March 31, 2026 of approximately US$9 million, anticipated to provide sufficient cash runway through Q4 2026.[3] The funding visibility, paired with the Phase 1 first-patient-dosed milestone, gives investors a defined catalyst window across the back half of 2026 for the first set of clinical readouts from the new program.The TriKE platform has been developed under an exclusive worldwide license agreement with the University of Minnesota, providing GT Biopharma with the rights to further develop and commercialize therapies using TriKE technology.[2] The Company's broader pipeline now spans GTB-3650 (the first 2nd-generation camelid nanobody TriKE, being tested clinically for CD33-positive leukemias including AML and MDS), GTB-5550 (the B7-H3 program for solid tumors), and GTB-7550 (in development for CD19-positive lymphoid malignancies and autoimmune disease).[4]Why The B7-H3 Convergence Matters The strategic case for GTB-5550 is sharpened by what is happening around B7-H3 across the rest of the oncology sector. The number of high-quality drug developers now actively pursuing the antigen, across multiple modalities, has shifted B7-H3 from "theoretically perfect" to "actively competitive" in less than 18 months. That competition matters less as a threat than as a validation. When IDEAYA is enrolling a bispecific B7-H3 / PTK7 antibody-drug conjugate, GSK is partnering its B7-H3 antibody-drug conjugate with Summit Therapeutics's ivonescimab in multiple solid tumor settings, and GT Biopharma is dosing the first patient in a B7-H3 NK cell engager Phase 1 trial — all within the first half of 2026 — the read-through is that the antigen has reached the threshold where the drug developer community has concluded the biology supports clinical translation.[1]What differentiates GT Biopharma inside that crowd is the mechanism. GTB-5550 is the only B7-H3-targeted natural killer cell engager in the Phase 1 patient-dosing window in 2026, and the only one tested with subcutaneous dosing. The TriKE design — engaging CD16 on NK cells, embedding an IL-15 moiety to drive NK cell proliferation and persistence, and targeting B7-H3 on tumor cells — gives the molecule a mechanistic profile that is structurally distinct from the antibody-drug conjugate and bispecific antibody approaches that dominate the rest of the B7-H3 development field.How GT Biopharma Sits Inside The B7-H3 And Solid Tumor Universe Summit Therapeutics Inc. (NASDAQ: SMMT) is one of the largest publicly traded oncology biotechs by market capitalization, with a market value around US$14 billion as of early 2026.[6] On January 12, 2026, Summit announced a clinical trial collaboration with GSK plc to evaluate ivonescimab — Summit's lead PD-1 / VEGF bispecific antibody — in combination with GSK's novel investigational B7-H3-targeting antibody-drug conjugate, risvutatug rezetecan (also known as GSK'227), across multiple solid tumor settings including small cell lung cancer.[7] Summit subsequently announced FDA acceptance of its Biologics License Application for ivonescimab on January 29, 2026, with a Prescription Drug User Fee Act goal action date of November 14, 2026.[8] Summit represents the institutional-scale comparable for the broader bispecific oncology investment thesis B7-H3 development is now inside.IDEAYA Biosciences, Inc. (NASDAQ: IDYA) announced in February 2026 that the first patient had been enrolled in its Phase 1 dose-escalation/expansion trial evaluating IDE034, a potential first-in-class PTK7 / B7-H3 bispecific TOP1 antibody-drug conjugate.[6] The design rationale is unusually specific: IDEAYA estimates that B7-H3 and PTK7 are co-expressed in approximately 30–40% of certain large solid tumor types — including lung, breast, ovarian, and colorectal cancers — while exhibiting minimal dual-antigen expression in normal tissue.[6] The drug is designed to be internalized only when both antigens are co-expressed on the same tumor cell, an architecture intended to enhance selectivity and tolerability compared to monovalent antibody formats.[6] IDEAYA offers the cleanest small-to-mid-cap B7-H3 development comparable in the public market.GSK plc (NYSE: GSK) is one of the largest pharmaceutical companies in the world by market cap, and the B7-H3-targeting antibody-drug conjugate risvutatug rezetecan (GSK'227) sits inside its broader oncology platform. The January 12, 2026 collaboration with Summit Therapeutics to combine GSK'227 with ivonescimab across multiple solid tumor settings, including small cell lung cancer, places GSK directly in the B7-H3 development conversation — and signals to the broader industry that one of the largest pharmaceutical companies in the world has concluded the B7-H3 modality is worth aggressive clinical investment.[7] GSK's involvement is a structural validation of the antigen that supports the broader investment thesis around B7-H3-targeted programs at every scale.Innate Pharma S.A. (NASDAQ: IPHA) has long been one of the more prominent publicly listed pure-play NK cell engager companies, with multispecific approaches that hit triggering receptors including NKp46 — adding to the broader CD16-anchored NK cell engagement framework. Innate's NK cell engager IPH6101 was advanced with Sanofi as a clinical-stage candidate for blood cancers. Innate provides a relevant comparable for the NK cell engager mechanism category specifically — distinct from the antibody-drug conjugate and bispecific antibody mechanisms that dominate most of the rest of the B7-H3 field — and helps frame the mechanism-specific investment thesis for an engager-platform company like GT Biopharma.Across all four comparables, the pattern is recognizable: 2026 is the year B7-H3 became one of the most-watched antigens in oncology, and the development pipelines now actively pursuing it span four different mechanism categories. GT Biopharma's distinction inside that crowd is that its TriKE platform is the only NK cell engager with a B7-H3 program currently dosing patients.The Catalyst Window Ahead The remainder of 2026 sets up a defined catalyst window for GT Biopharma. The Phase 1 dose-escalation trial for GTB-5550 is now enrolling, with the first patient dosed on May 14, 2026, and updates anticipated in 2H 2026 as the trial progresses through dose escalation cohorts.[3] The Company's cash position of approximately US$9 million as of March 31, 2026 is expected to provide sufficient runway through Q4 2026 — meaning the question of when initial efficacy or safety signals can be expected, and when additional capital may need to be raised against initial Phase 1 read, are both visible inside the next two to three quarters.[3]For investors who have read the B7-H3 convergence — and concluded that the antigen has reached the validation threshold where mechanism differentiation now matters — GT Biopharma offers a small-cap, single-platform exposure to the only NK cell engager program currently in B7-H3 patient dosing. Whether the Phase 1 data ultimately supports translation into a registrational program will be tested cohort by cohort across the back half of 2026 and into 2027. The window for new entrants into the B7-H3 antigen-targeted clinical field is no longer wide open — but the window for differentiated mechanisms inside it has, briefly, never been more visible.CONTACT:USA News Group
info @therooster-2873Article Sources[1] https://www.globenewswire.com/news-release/2026/05/14/3295057/0/en/A-Cancer-Antigen-Long-Thought-Untouchable-Is-Suddenly-the-Hottest-Target-in-Oncology.html [2] https://www.manilatimes.net/2026/05/14/tmt-newswire/globenewswire/gt-biopharma-announces-first-patient-dosed-in-phase-1-trial-of-gtb-5550-a-b7-h3-targeted-natural-killer-nk-cell-engager-for-solid-tumors/2343964 [3] https://www.biospace.com/press-releases/gt-biopharma-reports-first-quarter-2026-financial-results [4] https://www.gtbiopharma.com/product-pipeline/overview [5] https://www.globenewswire.com/news-release/2026/02/03/3231077/0/en/GT-Biopharma-Announces-FDA-Clearance-of-Investigational-New-Drug-IND-Application-for-GTB-5550-TriKE-a-B7-H3-Targeted-Natural-Killer-NK-Cell-Engager-for-Solid-Tumors-Expressing-B7-H.html [6] https://investingnews.com/a-cancer-antigen-long-thought-untouchable-is-suddenly-the-hottest-target-in-oncology/ [7] https://www.sec.gov/Archives/edgar/data/0001599298/000159929826000004/a2026_prx0112xannounceme.htm [8] https://www.sec.gov/Archives/edgar/data/0001599298/000159929826000006/smmt-20260129.htmDISCLAIMER NOTICEDISCLAIMER/DISCLOSURE:Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a digital media distribution and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). This article is being distributed by USA News Group on behalf of MIQ. MIQ has been paid a fee for GT Biopharma, Inc. advertising and digital media from Creative Direct Marketing Group ("CDMG"). There may be 3rd parties who may have shares of GT Biopharma, Inc. and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this article or email as the basis for any investment decision. The owner/operator of MIQ currently owns shares of GT Biopharma, Inc. that were purchased in the open market and reserves the right to buy and sell, and will buy and sell shares of GT Biopharma, Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company; no further notice will be given, but let this disclaimer serve as notice that all material disseminated by MIQ has been reviewed and approved on behalf of GT Biopharma, Inc. by CDMG; this is a digital media distribution.While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our article is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.Logo - https://mma.prnewswire.com/media/2838876/5656770/USA_News_Group_Logo.jpg View original content to download multimedia:https://www.prnewswire.com/news-releases/b7-h3-becomes-the-hottest-antigen-in-oncology-and-one-nk-engager-enters-clinic-302775099.htmlSOURCE USA News Group Original: B7-H3 Becomes The Hottest Antigen In Oncology, And One NK Engager Enters Clinic
US Market News
2月前
IDEAYA Biosciences Announces Late-Breaking Abstract Oral Presentation at ASCO 2026 to Provide Complete Data from Phase 2/3 Registrational Trial (OptimUM-02) of Darovasertib in Combination with Crizotinib in 1L HLA*A2-Negative Metastatic Uveal MelanomaApril 21, 2026 10:15 AM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif., April 21, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, today announced they have been selected for a late-breaking abstract (LBA) oral presentation to provide the complete data from the Phase 2/3 registrational trial (OptimUM-02) of darovasertib in combination with crizotinib in first-line (1L) HLA*A2-negative metastatic uveal melanoma at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place on May 29-June 2 in Chicago, Illinois. The presentation will include detail and additional data from OptimUM-02 that were not disclosed with the company's topline release.
Presentation detailsLate-Breaking Abstract Number: LBA9503Date and Time: June 1, 2026, 8-11AM CDT, Oral Abstract Session, Melanoma/Skin CancersTitle: Darovasertib Plus Crizotinib vs Investigator's Choice as First-Line Treatment for Patients with HLA-A2 Negative Metastatic Uveal Melanoma: Primary Results from the OptimUM-02 trialPresenter: Dr. Marlana Orloff, M.D., Associate Professor of Medical Oncology, Thomas Jefferson University HospitalAbout IDEAYA BiosciencesIDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding IDEAYA Biosciences' expectations with respect to the presentation of data from the Phase 2/3 OptimUM-02 trial, including the scope, content, timing, and potential significance of additional data to be presented at the 2026 ASCO Annual Meeting, as well as the potential therapeutic benefit and clinical development of darovasertib in combination with crizotinib for the treatment of metastatic uveal melanoma. Such forward-looking statements are based on management's current expectations, assumptions and beliefs and involve substantial risks and uncertainties that could cause actual results, including, but not limited to, those related to IDEAYA's clinical programs, commercial activities, and performance and/or achievements, to differ significantly and/or materially from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including the process of designing and conducting preclinical and clinical trials, enrollment rates, safety outcomes, efficacy results, regulatory interactions and decisions, and the ability to translate preclinical findings into clinical benefit, manufacturing and supply risks, competition, changes in standard of care, the timing and success of commercialization efforts, the outcome of collaborations and licensing arrangements, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of financial resources to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. A further description of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, are in IDEAYA's filings with the Securities and Exchange Commission, including IDEAYA's most recent Annual Report on Form 10-K and any current and periodic reports filed with the U.S. Securities and Exchange Commission.Investor and Media ContactIDEAYA Biosciences
Joshua Bleharski, Ph.D.
Chief Financial Officer
investor@ideayabio.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-late-breaking-abstract-oral-presentation-at-asco-2026-to-provide-complete-data-from-phase-23-registrational-trial-optimum-02-of-darovasertib-in-combination-with-crizotinib-in-1l-hlaa2-negative-meta-302747826.htmlSOURCE IDEAYA Biosciences, Inc.
Original: IDEAYA Biosciences Announces Late-Breaking Abstract Oral Presentation at ASCO 2026 to Provide Complete Data from Phase 2/3 Registrational Trial (OptimUM-02) of Darovasertib in Combination with Crizotinib in 1L HLA*A2-Negative Metastatic Uveal Melanoma
US Market News
2月前
IDEAYA Biosciences and Servier Announce Positive Topline Results from Phase 2/3 Registrational Trial (OptimUM-02) of Darovasertib in Combination with Crizotinib in First-line HLA-A*02:01-Negative Metastatic Uveal MelanomaApril 13, 2026 6:00 AM
PR Newswire (US)
Trial met the primary endpoint showing statistically significant improvement in median PFS by BICR, with 6.9 months for the darovasertib combination versus 3.1 months for ICT (HR: 0.42; 95% CI: 0.30, 0.59; p-value: 10,000 patients globally (including North America, Europe and Australia) and >3,000 patients in the United States, with approximately 50% of patients progressing to metastatic disease (mUM). We estimate the majority (50-70%) of mUM patients are of the HLA-A*02:01-negative serotype. Currently, there are no FDA-approved systemic therapies for primary UM and no FDA-approved therapies for patients with HLA-A*02:01-negative mUM.About IDEAYA BiosciencesIDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. IDEAYA's corporate presentation is available on its website: https://ir.ideayabio.com/ About ServierServier is an independent international pharmaceutical group governed by a foundation. With its governance model, the Group is committed to therapeutic progress to serve patients and integrates the patient voice at every stage of the medicine life cycle. As a leading global player in cardiology and venous diseases, Servier aims to become a leading innovator in oncology and neurology. The Group intends to deliver targeted therapeutic solutions, particularly in rare cancers and neurological diseases, and invests nearly 20% of its brand-name sales in R&D. Headquartered in France, Servier relies on its more than 20,000 employees and a solid geographic presence with medicines distributed in more than 130 countries. In the 2024/25 financial year, the Group achieved revenues of €6.9 billion. More information on the Group website: servier.comFollow us on social media: LinkedIn, Facebook, X, InstagramForward-Looking StatementsThis press release contains forward-looking statements, including, but not limited to, statements related to the clinical significance and potential therapeutic benefit of darovasertib in combination with crizotinib; the interpretation of the topline results from the OptimUM-02 trial; the potential for the combination to become a new standard of care for first-line HLA-A*02:01-negative metastatic uveal melanoma; the sufficiency of the trial results to support regulatory submissions; the preliminary trends in overall survival data; the safety and tolerability profile of darovasertib combination; the timing and plans for submission of a New Drug Application (NDA) in the second half of 2026; the potential for accelerated approval in the United States; the timing and content of future data presentations; the development, regulatory and commercial plans for darovasertib; and the potential market opportunity for the combination therapy. Such forward-looking statements are based on management's current expectations, assumptions and beliefs and involve substantial risks and uncertainties that could cause actual results, including, but not limited to, those related to IDEAYA's clinical programs, commercial activities, and performance and/or achievements, to differ significantly and/or materially from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including the process of designing and conducting preclinical and clinical trials, enrollment rates, safety outcomes, efficacy results, regulatory interactions and decisions, and the ability to translate preclinical findings into clinical benefit, manufacturing and supply risks, competition, changes in standard of care, the timing and success of commercialization efforts, the outcome of collaborations and licensing arrangements, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of financial resources to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. A further description of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, are in IDEAYA's filings with the Securities and Exchange Commission, including IDEAYA's most recent Annual Report on Form 10-K for the year ended December 31, 2025 filed on February 17, 2026 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.Investor and Media ContactIDEAYA Biosciences
Joshua Bleharski, Ph.D.
Chief Financial Officer
investor@ideayabio.comServier
Service presse
Presse@servier.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-and-servier-announce-positive-topline-results-from-phase-23-registrational-trial-optimum-02-of-darovasertib-in-combination-with-crizotinib-in-first-line-hla-a0201-negative-metastatic-uveal-melanoma-302739905.htmlSOURCE IDEAYA Biosciences, Inc.
Original: IDEAYA Biosciences and Servier Announce Positive Topline Results from Phase 2/3 Registrational Trial (OptimUM-02) of Darovasertib in Combination with Crizotinib in First-line HLA-A*02:01-Negative Metastatic Uveal Melanoma
US Market News
2月前
IDEAYA Biosciences Announces First-Patient-In for Phase 1 Trial of IDE574, a Potential First-In Class Dual Inhibitor of KAT6/7 to Target Multiple Solid Tumor Indications, including Breast, Prostate, CRC, and Lung CancerApril 6, 2026 6:00 AM
PR Newswire (US)
Potential first-in-class and selective equipotent dual inhibitor of KAT6/7 with single-digit to low teens nano-molar cellular potency in target engagement assays against KAT6 and KAT7, and ~350-to-2,000-fold selectivity over the KAT5 and KAT8 paralogsKAT6/7 dual inhibitor demonstrates greater monotherapy efficacy and durability than KAT6 selective inhibitors in preclinical CDX and PDX modelsMultiple combination opportunities with IDE574 and IDEAYA's proprietary pipelinePotential first-in-class and best-in-class preclinical profile will be presented at AACR 2026SOUTH SAN FRANCISCO, Calif., April 6, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, today announced that the first patient has been enrolled in its Phase 1 dose escalation trial evaluating IDE574, a potential first-in-class oral small molecule equipotent dual inhibitor of the lysine acetyltransferase (KAT) 6 and 7 paralogs, both of which have been shown to support cancer cell survival. The company is planning to evaluate safety, efficacy and pharmacokinetics of IDE574 as a monotherapy in the Phase 1 dose escalation trial in solid tumor patients, including breast, prostate, colorectal, and lung cancer.
"Targeting mechanisms of resistance and tumor heterogeneity in cancer are core strategies of our R&D efforts, and we are excited to advance IDE574 in the clinic to evaluate its potential as a monotherapy agent to drive deeper, more durable antitumor responses for patients versus historical clinical data published with KAT6-selective agents," said Michael White, Ph.D., Chief Scientific Officer of IDEAYA Biosciences. "We are thrilled to advance another potential first-in-class agent into the clinic that targets large solid tumor indications of high unmet need, including breast, prostate, CRC, and lung cancer. We believe the novel chromatin remodeling mechanism of the KAT6/7 dual inhibitor IDE574, has the potential for monotherapy efficacy and to treat breast cancer patient's refractory to hormone-based therapy due to ESR1 mutations, and to evaluate rational combinations with assets in the IDEAYA pipeline," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.IDE574 is a selective, equipotent dual inhibitor of both KAT6 and KAT7 with single-digit to low-teen nanomolar cellular potency in target engagement assays, which spares other structurally similar KAT paralogs with approximately a 350-to-2,000-fold selectivity windows versus KAT5 and KAT8, both of which are required for normal cell function. KAT6 and KAT7 are epigenetic modulators of cell identity and lineage commitment programs that are corrupted by oncogenic transformation. Estrogen-receptor 1 mutations (ESR1) is a common acquired resistance mechanism to endocrine based therapy in breast cancer with prevalence from 10 to 50% (Fuqua, et al., Cancer, July 2019; Zundelevich, et al., Breast Cancer Research, February 2020) highlighting the unmet need for alternative drug mechanisms, such as KAT6/7. IDE574 has shown robust and durable monotherapy anti-tumor activity, superior to KAT6 inhibition alone, in preclinical tumor models with 8p11 amplifications and ESR1 mutations, as well as in selected indications dependent upon lineage-specific transcription factor activity.About IDEAYA BiosciencesIDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the potential therapeutic benefits, safety, tolerability, efficacy, pharmacokinetics and clinical development of IDE574; the potential of IDE574 as a first-in-class or best-in-class therapy; the expected design, timing, and results of the Company's Phase 1 clinical trial; the potential for IDE574 to demonstrate monotherapy activity or durability of response; the potential to address resistance mechanisms, including ESR1 mutations; the applicability of IDE574 across multiple solid tumor indications; and the potential for combination strategies with IDEAYA's pipeline. Such forward-looking statements are based on management's current expectations, assumptions and beliefs and involve substantial risks and uncertainties that could cause actual results, including, but not limited to, those related to IDEAYA's clinical programs, commercial activities, and performance and/or achievements, to differ significantly and/or materially from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including the process of designing and conducting preclinical and clinical trials, enrollment rates, safety outcomes, efficacy results, regulatory interactions and decisions, and the ability to translate preclinical findings into clinical benefit, manufacturing and supply risks, competition, changes in standard of care, the timing and success of commercialization efforts, the outcome of collaborations and licensing arrangements, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of financial resources to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. A further description of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, are in IDEAYA's filings with the Securities and Exchange Commission, including IDEAYA's most recent Annual Report on Form 10-K and any current and periodic reports filed with the U.S. Securities and Exchange Commission.Investor and Media Contact
IDEAYA Biosciences
Joshua Bleharski, Ph.D.
Chief Financial Officer
investor@ideayabio.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-first-patient-in-for-phase-1-trial-of-ide574-a-potential-first-in-class-dual-inhibitor-of-kat67-to-target-multiple-solid-tumor-indications-including-breast-prostate-crc-and-lung-cancer-302734096.htmlSOURCE IDEAYA Biosciences, Inc.
Original: IDEAYA Biosciences Announces First-Patient-In for Phase 1 Trial of IDE574, a Potential First-In Class Dual Inhibitor of KAT6/7 to Target Multiple Solid Tumor Indications, including Breast, Prostate, CRC, and Lung Cancer
US Market News
2月前
IDEAYA Biosciences Announces First-Patient-In for Phase 1 Combination Study of IDE849, DLL3 TOP1 ADC, and IDE161, PARG Inhibitor, in DLL3 Upregulated Solid Tumor Indications, including SCLC, NETs, NECs, and MelanomaMarch 30, 2026 6:00 AM
PR Newswire (US)
FPI achieved for first-in-class combination of IDE849 (DLL3 TOP1 ADC) and IDE161 (PARG inhibitor). IDE161 (PARG) induced accumulation of TOP1 lesions enhances the efficacy and durability of TOP1 ADCs in multiple preclinical modelsIDE849 Phase 1 study advancing globally to determine RP2D, including current dose evaluation at 3.5 mg/kg IV Q3W. Multiple PRs observed at 2.4 mg/kg IV Q3W expansion cohort, including 3 PRs out of 4 SCLC patients pre-treated with IMDELLTRA®Targeting IDE849 monotherapy, and IDE849 and IDE161 combination clinical data update in H2 2026SOUTH SAN FRANCISCO, Calif., March 30, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced first-patient-in for a Phase 1 clinical trial combination study to evaluate IDE849, a potential first-in-class delta-like ligand 3 (DLL3)-targeting Topo-I-payload antibody drug conjugate (ADC) program, and IDE161, a potential first-in-class poly(ADP-ribose) glycohydrolase (PARG) inhibitor. The Phase 1 combination study will be evaluated in DLL3 upregulated solid tumor indications, including small cell lung cancer (SCLC), neuroendocrine tumors (NETs), neuroendocrine carcinomas (NECs), and melanoma.
"We are excited about the progress in our Phase 1 IDE849 monotherapy study to determine the RP2D and to initiate a registrational study by year-end, and the advancement of our wholly owned first-in-class clinical combination of IDE849 and IDE161 in DLL3 upregulated solid tumor indications," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. "We are leveraging our deep scientific expertise in DNA damage repair to enable this rational combination with IDE161, with the goal of inducing accumulation of TOP1 lesions to enhance the clinical efficacy and durability of our proprietary TOP1-payload ADCs, including IDE849 and IDE034, a Phase 1 B7H3/PTK7 bispecific TOP1 ADC," said Michael White, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.IDEAYA is advancing a multi-site global Phase 1 clinical trial for IDE849 in DLL3 upregulated solid tumor indications, including SCLC, NETs, and NECs, and melanoma (NCT07174583). The study will be enrolling patients globally, including in North America, Europe, Australia, South America, and Asia. In this ongoing Phase 1 dose escalation study, IDE849 is currently evaluating a 3.5 mg/kg IV dose once every 3-weeks (Q3W). Next, to determine the recommended Phase 2 dose (RP2D), IDEAYA is also enrolling patients in a IDE849 expansion cohort at the 2.4 mg/kg IV dose Q3W, where multiple partial responses (PRs) have been observed by RECIST 1.1, including 3 PRs out of 4 SCLC patients pre-treated with IMDELLTRA® (tarlatamab-dlle). The preliminary safety and efficacy profile observed to date in the IDEAYA sponsored study is consistent with the clinical data presented by our China-region partner Jiangsu Hengrui Pharmaceuticals Co. Ltd., at the IASLC World Conference on Lung Cancer 2025 (WCLC 2025).In addition, IDE849 is being evaluated in a clinical combination with IDEAYA's potential first-in-class Phase 1 PARG inhibitor, IDE161. IDEAYA has presented preclinical combination mechanism and synergy efficacy data of IDE161/PARG with TOP1-payload based ADCs at WCLC 2025. IDE161 prevents the removal of poly(ADP-ribose) chains generated by PARP during the DNA damage response, leading to persistent PARylation and impaired resolution of DNA repair complexes. Together with TOP1-payload ADCs, this unique mechanism-of-action results in sustained TOP1 cleavage complexes and the accumulation of DNA damage that delivers enhanced anti-tumor activity. We believe this potential first-in-class combination has the potential to enhance durability of IDEAYA's TOP1-payload based ADC pipeline, including IDE849 and IDE034 (Phase 1 B7H3/PTK7 Bispecific TOP1 ADC).DLL3 has been reported to be upregulated in multiple solid tumor types, including in SCLC, NETs, NSCLC, melanoma, among others. DLL3 has limited extracellular expression in normal tissues, making it a promising potential therapeutic target in these solid tumors, for which there remains significant unmet medical need.About IDEAYA BiosciencesIDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets.Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to IDEAYA's expectations, plans, and beliefs related to its clinical development programs, including the ongoing Phase 1 clinical trial evaluating IDE849 as a monotherapy and in combination with IDE161; the potential safety, tolerability, efficacy, and durability of IDE849 and IDE161; the potential therapeutic benefit and mechanism of action of IDE849, IDE161, and their combination; the potential of IDE849 and IDE161 to be first-in-class therapies; IDEAYA's plans to determine the recommended Phase 2 dose (RP2D) for IDE849; the timing and progress of IDEAYA's clinical trials, including plans to initiate a registrational study for IDE849; the expected timing of clinical data updates, including potential updates in the second half of 2026; and the potential applicability of IDEAYA's TOP1-payload ADC platform across multiple tumor types. Such forward-looking statements are based on management's current expectations, assumptions and beliefs and involve substantial risks and uncertainties that could cause actual results, including, but not limited to, those, related to IDEAYA's clinical programs, commercial activities, and performance and/or achievements, to differ significantly and/or materially from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including the process of designing and conducting preclinical and clinical trials, enrollment rates, safety outcomes, efficacy results, regulatory interactions and decisions, and the ability to translate preclinical findings into clinical benefit, manufacturing and supply risks, competition, changes in standard of care, the timing and success of commercialization efforts, the outcome of collaborations and licensing arrangements, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of financial resources to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. A further description of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, are in IDEAYA's filings with the Securities and Exchange Commission, including IDEAYA's most recent Annual Report on Form 10-K and any current and periodic reports filed with the U.S. Securities and Exchange Commission.Investor and Media Contact
IDEAYA Biosciences
Joshua Bleharski, Ph.D.
Chief Financial Officer
investor@ideayabio.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-first-patient-in-for-phase-1-combination-study-of-ide849-dll3-top1-adc-and-ide161-parg-inhibitor-in-dll3-upregulated-solid-tumor-indications-including-sclc-nets-necs-and-melanoma-302727304.htmlSOURCE IDEAYA Biosciences, Inc.
Original: IDEAYA Biosciences Announces First-Patient-In for Phase 1 Combination Study of IDE849, DLL3 TOP1 ADC, and IDE161, PARG Inhibitor, in DLL3 Upregulated Solid Tumor Indications, including SCLC, NETs, NECs, and Melanoma
US Market News
3月前
IDEAYA Biosciences Upcoming Investor Relations Events and Updated Darovasertib Topline Results Guidance from Phase 2/3 OptimUM-02 TrialMarch 22, 2026 10:00 AM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif., March 22, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in upcoming investor relations events and provided updated guidance related to the timing of its upcoming topline data release from the Phase 2/3 OptimUM-02 trial in first-line HLA-A2*-negative metastatic uveal melanoma.
Darovasertib Phase 2/3 OptimUM-02 Trial Topline Results Investor and Analyst Webcast:Updated Topline Results Guidance: The database lock is projected in the first half of April, followed by the topline data analysis thereafterLive investor and analyst webcast will be hosted by IDEAYA management and a guest key opinion leaderPre-registration will be available prior to the event through IDEAYA's investor relations events page at https://ir.ideayabio.com/eventsBank of America Merrill Lynch Health Care Conference
Tuesday, May 12th, 2026Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Bank of AmericaStifel 2026 Targeted Oncology Virtual Forum
Tuesday, May 19th, 2026Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Laura Prendergast, Managing Director, PhDA live audio webcast of the events will be available under the "Investors/Events" section of the IDEAYA website at https://ir.ideayabio.com/events and/or through the conference host. A replay of the webcasts will be accessible for 30 days following the live events.About IDEAYA BiosciencesIDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.Forward-Looking StatementsThis press release contains forward-looking statements, including, but not limited to, statements related to the expected timing of database lock, analysis and topline results from the Phase 2/3 OptimUM-02 trial; the anticipated timing and content of and participation in and/or presentation at investor and analyst events and webcasts; and IDEAYA's expectations regarding its clinical development activities. Forward-looking statements are based on IDEAYA's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, risks related to the timing, progress, and results of clinical trials, including the OptimUM-02 trial; the timing of data readouts, database analysis; the risk that topline results may not be predictive of final results; the potential for delays in clinical development; regulatory developments; and other risks described in IDEAYA's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. IDEAYA undertakes no obligation to update or revise any forward-looking statements, except as required by law.Investor and Media Contact
IDEAYA Biosciences
Joshua Bleharski, Ph.D.
Chief Financial Officer
investor@ideayabio.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-upcoming-investor-relations-events-and-updated-darovasertib-topline-results-guidance-from-phase-23-optimum-02-trial-302721438.htmlSOURCE IDEAYA Biosciences, Inc.
Original: IDEAYA Biosciences Upcoming Investor Relations Events and Updated Darovasertib Topline Results Guidance from Phase 2/3 OptimUM-02 Trial
US Market News
3月前
IDEAYA Biosciences Announces Upcoming Presentations at AACR 2026 Highlighting Multiple Clinical Stage Pipeline ProgramsMarch 18, 2026 6:00 AM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif., March 18, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, today announced the publication of abstracts for three poster presentations at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 17-22 in San Diego, California. The presentations will highlight preclinical data from three potential first-in-class programs from IDEAYA's clinical stage pipeline: IDE034, a PTK7/B7H3 bi-specific topoisomerase-1 (TOP1) antibody-drug conjugate (ADC); IDE574, a potent dual inhibitor of the lysine acetyltransferase (KAT) 6 and 7; and IDE892, an MTA-cooperative inhibitor of PRMT5. The company is currently conducting Phase 1 clinical studies to evaluate safety, tolerability, PK and efficacy of these three programs across a broad range of large solid tumor indications, including lung, colorectal, pancreatic, breast, and prostate cancer.
"We are excited for the opportunity to showcase data from our earlier stage clinical pipeline at this year's AACR. These programs align closely with our clinical focus within TOP1 ADCs and DNA damage repair (DDR) mechanisms, synthetic lethality and modulation of epigenetic pathways to overcome resistance mechanisms in cancer. Our goal is to identify first-in-class and best-in-class product profiles to deliver robust monotherapy efficacy and rational combinations that have the potential to drive deeper, more durable responses for patients living with cancer," said Michael White, Ph.D., Chief Scientific Officer of IDEAYA Biosciences.Details of the poster presentations are as follows:Author: Munoz Delgado, D. et al.
Title: IDE034, A bispecific antibody-drug conjugate co-targeting PTK7 and B7-H3, exhibits avidity-driven selectivity and enhanced antitumor activity versus mono-specific ADCs
Poster Number: 232
Session Title: DNA Damage and Repair 1Date and Time: Sunday, April 19, 2026 at 2:00pm-5:00pm PDTAuthor: Gupta, M. et al.
Title: The KAT6/7 inhibitor IDE574 disrupts tumor lineage identity and drug tolerance to deliver robust antitumor activity in biomarker selected indications
Poster Number: 4483
Session Title: Epigenetic Modulators 1Date and Time: Tuesday, April 21, 2026 at 9:00am-12:00pm PDTAuthor: Rao, A. et al.
Title: IDE892 is a highly potent and selective PRMT5 inhibitor, with MTA-positive and SAM-negative cooperativity, optimized for development in MTAP-del cancers in combination with the allosteric MAT2A inhibitor IDE397
Poster Number: 4505
Session Title: Epigenetic Modulators 1Date and Time: Tuesday, April 21, 2026 at 9:00am-12:00pm PDTThe poster presentations will be made available on IDEAYA's corporate website following the meeting: https://ir.ideayabio.com/. About IDEAYA BiosciencesIDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.Forward-Looking StatementsThis press release contains forward-looking statements, including, but not limited to, statements regarding the potential first-in-class profile, safety, tolerability, pharmacokinetics and therapeutic benefit of IDE034, IDE574 and IDE892; the potential of these programs to drive deeper, more durable responses for patients; the mechanistic rationale for targeting TOP1, DNA damage repair pathways, synthetic lethality, and epigenetic modulation; the advancement and progress of ongoing Phase 1 clinical trials; the potential for future combination strategies, including IDE892 in combination with IDE397; and the broader development strategy and clinical potential of IDEAYA's pipeline. Such forward-looking statements are based on management's current expectations, assumptions and beliefs and involve substantial risks and uncertainties that could cause actual results, including, but not limited to, those related to IDEAYA's clinical programs, commercial activities, and performance and/or achievements, to differ significantly and/or materially from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including the process of designing and conducting preclinical and clinical trials, enrollment rates, safety outcomes, efficacy results, regulatory interactions and decisions, and the ability to translate preclinical findings into clinical benefit, manufacturing and supply risks, competition, changes in standard of care, the timing and success of commercialization efforts, the outcome of collaborations and licensing arrangements, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of financial resources to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. A further description of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, are in IDEAYA's filings with the Securities and Exchange Commission, including IDEAYA's most recent Annual Report on Form 10-K and any current and periodic reports filed with the U.S. Securities and Exchange Commission.Investor and Media ContactIDEAYA Biosciences
Joshua Bleharski, Ph.D.
Chief Financial Officer
investor@ideayabio.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-upcoming-presentations-at-aacr-2026-highlighting-multiple-clinical-stage-pipeline-programs-302715276.htmlSOURCE IDEAYA Biosciences, Inc.
Original: IDEAYA Biosciences Announces Upcoming Presentations at AACR 2026 Highlighting Multiple Clinical Stage Pipeline Programs
US Market News
3月前
IDEAYA Biosciences Announces First-Patient-In for Phase 1 Trial of IDE892, a Potential Best-In-Class PRMT5 Inhibitor for MTAP-Deleted Solid Tumors, and Provides MTAP and CDKN2A Pipeline UpdateMarch 9, 2026 6:00 AM
PR Newswire (US)
Potential best-in-class profile, including ~1,400-fold selective binding to MTA-PRMT5 versus SAM-PRMT5 complexes, and single-digit nanomolar potency in MTAP-deleted cell linesIDE892 is being evaluated as a monotherapy agent in MTAP-deleted solid tumors, including NSCLC and PDAC, and targeting combination FPI with IDE397 (MAT2A) in mid-2026Targeting nomination of a first-in-class CDKN2A development candidate in H2 2026 and IND in H1 2027; prevalence of CDKN2A-deficiency has been reported at over 80% in PDACIDEAYA will deprioritize combination activities with Trodelvy as part of a strategic prioritization of its proprietary MTAP-deleted and CDKN2A pipelineSOUTH SAN FRANCISCO, Calif., March 9, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, today announced that the first patient has been enrolled in its Phase 1 clinical trial evaluating IDE892, an investigational MTA-cooperative PRMT5 inhibitor being developed for patients with MTAP-deleted solid tumors, including non-small cell lung cancer and pancreatic cancer. The trial will assess safety, tolerability, pharmacokinetics, and pharmacodynamics of IDE892 as a monotherapy agent and in combination with IDE397, IDEAYA's MAT2A inhibitor, in mid-2026. Dual inhibition of IDE892 and IDE397 has demonstrated durable and well-tolerated tumor regressions in preclinical MTAP-deleted tumor models, including in NSCLC.
"We are excited to have enrolled the first patient in our Phase 1 clinical trial evaluating IDE892 in patients with MTAP-deleted solid tumors, including non-small cell lung cancer and pancreatic cancer. We designed IDE892 with potential best-in-class properties, including specific biophysical and pharmacokinetic properties that we believe will maximize its therapeutic window and clinical efficacy, both as a monotherapy agent and as a combination partner with our MAT2A inhibitor, IDE397. Next, we look forward to advancing our first-in-class CDKN2A-defiency program to progress our broader corporate strategy of enabling wholly owned rational combinations targeting MTAP-deletion," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.IDE892 was designed to be a potential best-in-class PRMT5 inhibitor, with ~1,400-fold selective binding to MTA-PRMT5 versus SAM-PRMT5 complexes and observed single-digit nano-molar potency in endogenous MTAP-deleted cell lines, and greater than 50-fold potency differential in MTAP-deleted versus MTAP wild type HCT116 isogenic cell lines. In addition, IDE892 inhibited the arginine dimethylation of a key PRMT5 substrate involved in mRNA splicing, spliceosome protein SmB (SmB-SDMA), with pico-molar potency in MTAP-deleted cell lines with greater than 100-fold potency differential versus an MTAP wild type cell line. IDE892 has demonstrated monotherapy regressions in MTAP-deleted preclinical models, and durable complete responses in combination with IDE397. Loss of MTAP leads to the accumulation of methylthioadenosine (MTA) and increased dependence on PRMT5 and MAT2A, two key enzymes involved in methylation and RNA splicing. In MTAP-deleted tumors, this biology establishes a robust synthetic lethal vulnerability that underpins the mechanistic rationale for combining IDE892 and IDE397. In preclinical studies, dual inhibition of PRMT5 and MAT2A with the combination of IDE892 and IDE397 resulted in potent anti-tumor activity in MTAP-deleted tumor models, including complete and durable responses at well-tolerated doses below those required for monotherapy activity.IDEAYA has also advanced its CDKN2A-deficiency program and is on track to select a potential first-in-class development candidate in H2 2026 with a target IND in H1 2027. IDEAYA has demonstrated robust monotherapy efficacy with its CDKN2A lead in multiple preclinical models, including in a KRAS mutation pancreatic model. IDEAYA plans to evaluate its CDKN2A-deficiency program preclinically as a monotherapy agent, and in combination with assets in its MTAP-deletion portfolio and potentially other RAS and KRAS targeted assets. CDKN2A-defiency is common in cancer, with a prevalence of over 80% in pancreatic cancer (M. Schutte, et al., Cancer Research, 1997; IDEAYA analysis, TCGA) and is typically co-deleted in MTAP-deletion solid tumors and a common co-alteration with KRAS mutations, particularly in pancreatic cancer, creating rational combination opportunities with MTAP-deletion and KRAS targeted therapies, respectively.As part of IDEAYA's strategic prioritization of its proprietary MTAP-deleted pipeline, including IDE397 and IDE892, and the advancement of its CDKN2A-deficiency program, the company has deprioritized its clinical combination activities with Trodelvy and will be concluding enrollment in the ongoing Phase 1/2 trials with Gilead. Based on preliminary data from these trials supporting the mechanistic rationale for the combination in MTAP-deleted cancers, IDEAYA may evaluate additional combinations between IDE397 and other TOP1 payload ADCs in this setting, including IDE034, its B7H3/PTK7 bispecific TOP1 ADC. MTAP deletion is estimated to occur in 15–20% of non-small cell lung cancer, up to 40% of pancreatic cancer, and approximately 15% of all solid tumors, and is commonly co-deleted with CDKN2A due to the proximity of the two genes on chromosome 9p21. There are no approved therapies for patients with MTAP deletion, highlighting the significant unmet need and important new opportunities for precision therapies.About IDEAYA BiosciencesIDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.Forward-Looking StatementsThis press release contains forward-looking statements, including, but not limited to, statements related to the potential best-in-class profile, safety, efficacy and therapeutic benefit of IDE892, IDE397 and IDEAYA's CDKN2A-deficiency program; the mechanistic rationale and potential clinical benefit of PRMT5 and MAT2A co-inhibition; the timing, progress, design and results of IDE892's Phase 1 clinical trial; the anticipated timing of first-patient-in for the IDE892 and IDE397 combination in mid-2026; the timing of CDKN2A development candidate selection in the second half of 2026 and IND submission in the first half of 2027; the potential for combination strategies involving IDE892, IDE397 and CDKN2A assets; the prevalence of MTAP deletion and CDKN2A deficiency in certain cancers; projected cost savings associated with strategic prioritization decisions; and the potential market opportunity for IDEAYA's product candidates. Such forward-looking statements are based on management's current expectations, assumptions and beliefs and involve substantial risks and uncertainties that could cause actual results, including, but not limited to, those related to IDEAYA's clinical programs, commercial activities, and performance and/or achievements, to differ significantly and/or materially from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including the process of designing and conducting preclinical and clinical trials, enrollment rates, safety outcomes, efficacy results, regulatory interactions and decisions, and the ability to translate preclinical findings into clinical benefit, manufacturing and supply risks, competition, changes in standard of care, the timing and success of commercialization efforts, the outcome of collaborations and licensing arrangements, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of financial resources to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. A further description of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, are in IDEAYA's filings with the Securities and Exchange Commission, including IDEAYA's most recent Annual Report on Form 10-K and any current and periodic reports filed with the U.S. Securities and Exchange Commission.Investor and Media ContactIDEAYA Biosciences
Joshua Bleharski, Ph.D.
Chief Financial Officer
investor@ideayabio.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-first-patient-in-for-phase-1-trial-of-ide892-a-potential-best-in-class-prmt5-inhibitor-for-mtap-deleted-solid-tumors-and-provides-mtap-and-cdkn2a-pipeline-update-302707246.htmlSOURCE IDEAYA Biosciences, Inc.
Original: IDEAYA Biosciences Announces First-Patient-In for Phase 1 Trial of IDE892, a Potential Best-In-Class PRMT5 Inhibitor for MTAP-Deleted Solid Tumors, and Provides MTAP and CDKN2A Pipeline Update
US Market News
3月前
IDEAYA Biosciences Announces First-Patient-In for Phase 1 Trial of IDE034, a Potential First-In-Class B7H3/PTK7 Bispecific TOP1 ADCFebruary 25, 2026 6:00 AM
PR Newswire (US)
Phase 1 dose escalation trial to determine safety, tolerability and PK of IDE034Potential as a monotherapy and in combination with proprietary PARG inhibitor, IDE161B7H3/PTK7 co-expressed in 30-40% of multiple solid tumor types, including lung, breast, ovarian and colorectal cancersSOUTH SAN FRANCISCO, Calif., Feb. 25, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, today announced that the first patient has been enrolled in its Phase 1 dose escalation/expansion trial evaluating IDE034, an investigational PTK7/B7H3 bispecific TOP1 ADC. The company is planning to evaluate safety, tolerability and PK of IDE034 as a monotherapy in the Phase 1 trial, and also plans to test combinations with agents that target the DNA damage response (DDR) pathway, such as their proprietary PARG inhibitor, IDE161. Dosing of the first patient with IDE034 triggers a $5 million milestone payment from IDEAYA to Biocytogen, pursuant to the Option and License Agreement between the companies.
"This is an important milestone for IDE034 as well as our broader ADC/DDR portfolio focused on exploring combinations of highly selective TOP1 ADCs with agents targeting the DDR pathway. We are excited to begin dosing patients with IDE034, a B7H3/PTK7 bispecific ADC that has demonstrated promising signs of efficacy as a monotherapy and synergy in combination with IDE161 across several preclinical tumor cell models. IDE034 is our second proprietary TOP1 ADC, building on the progress we have made with IDE849, our DLL3 TOP1 ADC currently in Phase 1 for SCLC and NEC, and represents another potentially first-in-class therapy for cancer patients in need of new and improved treatment options," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.IDE034 is a potentially first-in-class B7H3/PTK7 bispecific TOP 1 ADC designed to be internalized only when its target antigens are co-expressed on the same tumor cell, which may enhance its selectivity and tolerability profile relative to monovalent antibody formats. IDEAYA estimates that B7H3/PTK7 are co-expressed in approximately 30-40% of certain large solid tumor types, including lung, breast, ovarian and colorectal cancers, while exhibiting minimal dual antigen expression in normal tissue. In preclinical tumor models, IDE034 has also demonstrated compelling combination potential with IDE161, the company's oral PARG inhibitor, that suggests these mechanisms may synergize to enhance the efficacy and durability of TOP1 ADCs. About IDEAYA BiosciencesIDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements regarding the clinical development, potential safety, tolerability, pharmacokinetic profile, efficacy and therapeutic potential of IDE034, both as a monotherapy and in combination with IDEAYA's proprietary PARG inhibitor, IDE161; the design, conduct, timing and outcomes of the Phase 1 clinical trial of IDE034; the potential benefits of IDEAYA's ADC/DDR portfolio and combination strategies; and the prevalence of B7H3/PTK7 co-expression in certain tumor types. Such forward-looking statements are based on management's current expectations, assumptions and beliefs and involve substantial risks and uncertainties that could cause actual results, including, but not limited to, those related to IDEAYA's preclinical and clinical programs, commercial activities, and performance and/or achievements, to differ significantly and/or materially from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including the process of designing and conducting preclinical and clinical trials, enrollment rates, safety outcomes, efficacy results, regulatory interactions and decisions, and the ability to translate preclinical findings into clinical benefit, manufacturing and supply risks, competition, changes in standard of care, the timing and success of commercialization efforts, the outcome of collaborations and licensing arrangements, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of financial resources to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. A further description of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, are in IDEAYA's filings with the Securities and Exchange Commission, including IDEAYA's most recent Annual Report on Form 10-K and any current and periodic reports filed with the U.S. Securities and Exchange Commission.Investor and Media ContactIDEAYA Biosciences
Joshua Bleharski, Ph.D.
Chief Financial Officer
investor@ideayabio.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-first-patient-in-for-phase-1-trial-of-ide034-a-potential-first-in-class-b7h3ptk7-bispecific-top1-adc-302696480.htmlSOURCE IDEAYA Biosciences, Inc.
Original: IDEAYA Biosciences Announces First-Patient-In for Phase 1 Trial of IDE034, a Potential First-In-Class B7H3/PTK7 Bispecific TOP1 ADC
US Market News
3月前
IDEAYA Biosciences Announces Appointment of Dr. Theodora (Theo) Ross, M.D., Ph.D., as Chief Development OfficerFebruary 23, 2026 6:00 AM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif., Feb. 23, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, today announced the appointment of Dr. Theodora (Theo) Ross into the newly created role of Chief Development Officer. In this role, Dr. Ross will be responsible for leading early clinical development for IDEAYA's emerging oncology pipeline and play a crucial role in guiding the company's long-term R&D strategy. Dr. Ross joins IDEAYA from AbbVie, where she served as Vice President, Head of Early Oncology R&D and Site Head for the Bay Area.
"We are thrilled to welcome Dr. Ross to IDEAYA as we advance our deep pipeline of potential first-in-class clinical-stage assets. Theo is an exceptionally talented and accomplished clinician with a proven track-record leading clinical execution and pipeline strategy for multiple global pharma companies. We look forward to her joining the IDEAYA leadership team to help drive our ambitious clinical development plan forward to support our next phase of growth," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences."I am honored and excited to join IDEAYA as the company advances one of the most innovative and scientifically driven oncology pipelines in biotech. I believe the greatest progress comes when we follow the science with rigor and focus, and when we prioritize what matters most to amplify the impact we can have for patients. IDEAYA has demonstrated that discipline by concentrating on programs and targets with strong scientific rationale and clinical promise, and I can't wait to contribute to that continued focus," said Dr. Ross.Dr. Ross brings over 30 years of experience in oncology, most recently having served as Vice President and Head of Early Oncology R&D and Site Head for AbbVie in the Bay Area. During her tenure, she led the advancement of five early clinical stage programs from first-in-human to Phase 1/2 clinical proof-of-concept studies across various solid tumor indications and served as the R&D champion for the $10 billion acquisition of Immunogen for AbbVie's first marketed solid tumor oncology asset, Elahere. Dr. Ross has also held the roles of Vice President of Global Development, Head of Precision Medicine, and Thoracic Oncology at Amgen and Vice President of Translational Medicine at Merck. Prior to her time in industry and relevant to the mission of IDEAYA, Dr. Ross was the head of the Cancer Genetics Department at University of Texas Southwestern Medical Center (UTSW) and had a 20-year tenure as an oncologist, laboratory scientist and professor at prominent cancer centers and academic institutions, including UTSW and the University of Michigan. Dr. Ross received her B.A. from Kalamazoo College and her M.D. and Ph.D. from Washington University. She completed her residency in internal medicine at Brigham and Women's Hospital, Harvard Medical School, and an oncology fellowship at Dana-Farber Cancer Institute, Harvard Medical School.About IDEAYA BiosciencesIDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. IDEAYA's corporate presentation is available on its website: https://ir.ideayabio.com/. Forward-Looking StatementsThis press release contains forward-looking statements, including, but not limited to, statements regarding IDEAYA's clinical development plans; the advancement and potential of its pipeline, including potential first-in-class clinical-stage assets; the expected contributions of Dr. Ross to IDEAYA's early clinical development efforts and long-term R&D strategy; the potential therapeutic impact of IDEAYA's product candidates; and IDEAYA's anticipated next phase of growth. Such forward-looking statements are based on management's current expectations, assumptions and beliefs and involve substantial risks and uncertainties that could cause actual results, including, but not limited to, those related to IDEAYA's clinical programs, commercial activities, and performance and/or achievements, to differ significantly and/or materially from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including the process of designing and conducting preclinical and clinical trials, enrollment rates, safety outcomes, efficacy results, regulatory interactions and decisions, and the ability to translate preclinical findings into clinical benefit, manufacturing and supply risks, competition, changes in standard of care, the timing and success of commercialization efforts, the outcome of collaborations and licensing arrangements, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of financial resources to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. A further description of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, are in IDEAYA's filings with the Securities and Exchange Commission, including IDEAYA's most recent Annual Report on Form 10-K and any current and periodic reports filed with the U.S. Securities and Exchange Commission.Investor and Media ContactIDEAYA Biosciences
Joshua Bleharski, Ph.D.
Chief Financial Officer
investor@ideayabio.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-appointment-of-dr-theodora-theo-ross-md-phd-as-chief-development-officer-302693873.htmlSOURCE IDEAYA Biosciences, Inc.
Original: IDEAYA Biosciences Announces Appointment of Dr. Theodora (Theo) Ross, M.D., Ph.D., as Chief Development Officer
US Market News
4月前
IDEAYA Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides a Business UpdateFebruary 17, 2026 6:00 AM
PR Newswire (US)
130 required PFS events confirmed by BICR in the Phase 2/3 OptimUM-02 trial of darovasertib and crizotinib combination in 1L HLA*A2-negative metastatic uveal melanoma (mUM); topline results expected by approximately the last week of MarchDarovasertib is anticipated to be in three randomized, Phase 3 registrational trials in uveal melanoma, including the metastatic, neoadjuvant and adjuvant settings, by H1 '26Initiation of IDE849 (DLL3 TOP1 ADC) monotherapy registrational study in the second line/refractory setting (2L+) of small cell lung cancer (SCLC) and/or neuroendocrine carcinomas (NEC) targeted by the end of 2026Preliminary clinical data update from IDEAYA-sponsored global Phase 1 trial of IDE849 expected by the end of 2026~$1.05 billion of cash, cash equivalents, and marketable securities as of December 31, 2025; expected to fund operations into 2030SOUTH SAN FRANCISCO, Calif., Feb. 17, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, provided a business update and announced financial results for the fourth quarter and full year ended December 31, 2025.
"We had a strong quarter of clinical execution, clinical pipeline expansion and commercial readiness activities. The key highlights include completing full enrollment of 437 patients in OptimUM-02, our Phase 2/3 registrational trial in first line HLA*A2-negative mUM, submission of IND filings for IDE034, a potential first-in-class B7H3/PTK7 bispecific TOP1 ADC, and IDE574, a KAT6/7 dual inhibitor, and continued build out of our U.S. commercial organization in anticipation of our upcoming topline PFS results," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.Selected Recent Developments and Upcoming MilestonesDarovasertib in Uveal Melanoma (UM)Topline results, including progression free survival (PFS) data, from ongoing registrational Phase 2/3 OptimUM-02 trial of the darovasertib and crizotinib combination in first line (1L) patients with HLA*A2-negative metastatic UM are expected by approximately the last week of March, pending completion of ongoing data collection, cleaning and analysis.130 PFS events required to trigger the topline readout have been confirmed by blinded independent central review (BICR);Randomized PFS analysis will be based on the intent-to-treat population (ITT) enrolled in the Phase 2b/3 portion of the trial, which comprises a total of approximately 313 patients randomized 2:1 to the treatment arm versus control;Topline PFS results, if positive, are anticipated to enable a potential accelerated approval filing in the United States.Darovasertib is anticipated to be in three randomized, Phase 3 registrational trials across all stages of uveal melanoma by H1 '26:OptimUM-02 (mUM): full enrollment of 437 patients is complete; overall survival (OS) data from these patients, when available, are expected to support a filing for full approval in 1L HLA*A2-negative mUM;OptimUM-10 (neoadjuvant): targeting to complete full enrollment of approximately 450 patients across enucleation and plaque brachytherapy cohorts by H1 '27;OptimUM-11 (adjuvant): trial initiation in collaboration with Servier planned in Q2 '26.Enrollment of approximately 100 HLA*A2-positive mUM patients in single-arm, Phase 2 OptimUM-01 trial of darovasertib in combination with crizotinib is expected to be complete by Q2 '26.Data may support a potential future submission to the U.S. Food and Drug Administration (FDA) to expand the labeled use of darovasertib and/or a national comprehensive cancer network (NCCN)/compendia listing to enable use of the combination in these patients.Targeting to submit two manuscripts for publication with data from 1) treatment naïve mUM patients and 2) HLA*A2-positive mUM patients enrolled in the OptimUM-01 trial in H1 '26 and H2 '26, respectively.Antibody-drug Conjugates (ADC) / DNA Damage Response (DDR) CombinationsIDE849 (DLL3 TOP1 ADC): targeting to provide a preliminary clinical data update from IDEAYA-sponsored global Phase 1 trial and initiate a monotherapy registrational study in the second line/refractory setting (2L+) of SCLC and/or NEC by the end of 2026.IDE034 (B7H3/PTK7 bispecific TOP1 ADC): received investigational new drug (IND) clearance from the U.S. FDA in Q4 '25; expect to achieve first-patient-in (FPI) in Phase 1 dose escalation trial in Q1 '26;Dosing of the first patient with IDE034 will trigger a $5 million milestone payment from IDEAYA to Biocytogen, pursuant to the Option and License Agreement between the companies.IDE161 (PARG): initiation of clinical combination studies with IDE849 in SCLC, NEC and other DLL3-overexpressing solid tumors in Q2 '26.MTAP PathwayIDE397 (MAT2A): planning to provide updated data from Phase 1/2 combination trial with Trodelvy in MTAP-deleted urothelial cancer (UC) at a medical conference in 2026.IDE892 (PRMT5): targeting initiation of Phase 1 monotherapy dose escalation trial in Q1 '26 to enable a combination trial with IDE397 in MTAP-deleted solid tumors in Q2 '26.Nomination of a development candidate for a potential first-in-class program targeting CDKN2A, the most common co-alteration of MTAP, expected in H2 '26 followed by IND submission to the U.S. FDA in H1 '27. Next Generation TherapiesIDE574 (KAT6/7): obtained IND clearance from the U.S. FDA in January 2026; targeting to initiate a Phase 1 dose escalation trial in patients with breast, lung, prostate and colorectal cancers Q1 '26.CorporateDarovasertib commercial readiness activities are advancing in the United States and globally with our partner, Servier.In December 2025, GlaxoSmithKline (GSK) notified IDEAYA of its intention to terminate the Collaboration, Option and License Agreement, dated June 15, 2020. Pursuant to the terms of the Agreement, GSK will transfer the Werner Helicase (IDE275) and Pol Theta (IDE705) clinical programs to IDEAYA in accordance with the applicable provisions of the Agreement.Fourth Quarter and Full Year 2025 Financial Results As of December 31, 2025, IDEAYA had cash, cash equivalents and marketable securities of approximately $1.05 billion, compared to $1.08 billion as of December 31, 2024. The decrease was primarily driven by net cash used in operations, offset by the $210.0 million upfront payment received from Servier related to the exclusive license agreement for darovasertib during the year ended December 31, 2025.Collaboration revenue for the three months ended December 31, 2025, totaled $10.9 million compared to $7.0 million for the three months ended December 31, 2024. Collaboration revenue was recognized for the performance obligations satisfied through December 31, 2025 related to the research and development services that are recognized over time under the Servier exclusive license agreement for darovasertib. As of December 31, 2025, the remaining balance for the research and development services performance obligations is $161.8 million related to the clinical trial cost reimbursements anticipated under the license agreement that will be recognized as IDEAYA collaboration revenue over time as the research and development services are completed.Research and development (R&D) expenses for the three months ended December 31, 2025 totaled $86.6 million compared to $140.2 million for the three months ended December 31, 2024. The decrease was primarily driven by a $75.0 million upfront payment under the license agreement for IDE849 with Hengrui Pharma during the three months ended December 31, 2024, offset by higher clinical trial and CMC manufacturing expenses to support our programs and personnel-related expenses during the three months ended December 31, 2025.General and administrative (G&A) expenses for the three months ended December 31, 2025 totaled $18.8 million compared to $11.0 million for the three months ended December 31, 2024. The increase was primarily due to higher personnel-related expenses, higher consulting and legal patent fees to support company growth and darovasertib commercial preparation activities.The net loss for the three months ended December 31, 2025, was $83.3 million compared to the net loss of $130.3 million for the three months ended December 31, 2024. Total stock compensation expense for the three months ended December 31, 2025, was $11.8 million compared to $9.5 million for the three months ended December 31, 2024.The net loss for the year ended December 31, 2025, was $113.7 million compared to the net loss of $274.5 million for the year ended December 31, 2024. Total stock compensation expense for the year ended December 31, 2025, was $46.1 million compared to $34.7 million for the year ended December 31, 2024.About IDEAYA BiosciencesIDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. IDEAYA's corporate presentation is available on its website: https://ir.ideayabio.com/. Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements regarding the expected timing and results of clinical trials, including patient enrollment, and data readouts; the potential for accelerated approval or full regulatory approval of darovasertib, alone or in combination with crizotinib; the anticipated design, initiation, enrollment, timing and outcomes of IDEAYA's ongoing and planned Phase 1, Phase 2, and Phase 3 clinical trials across its pipeline programs, including IDE849, IDE034, IDE161, IDE397, IDE892 and IDE574; the therapeutic potential, safety, tolerability, efficacy, and combination potential of IDEAYA's product candidates; the expected prevalence of target patient populations; commercial readiness activities and future commercialization efforts; anticipated collaboration activities and transfers of clinical programs; and IDEAYA's expectations regarding its cash runway and ability to fund operations into 2030. Such forward-looking statements are based on management's current expectations, assumptions and beliefs and involve substantial risks and uncertainties that could cause actual results, including, but not limited to, those related to IDEAYA's clinical programs, commercial activities, and performance and/or achievements, to differ significantly and/or materially from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including the process of designing and conducting preclinical and clinical trials, enrollment rates, safety outcomes, efficacy results, regulatory interactions and decisions, and the ability to translate preclinical findings into clinical benefit, manufacturing and supply risks, competition, changes in standard of care, the timing and success of commercialization efforts, the outcome of collaborations and licensing arrangements, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of financial resources to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. A further description of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, are in IDEAYA's filings with the Securities and Exchange Commission, including IDEAYA's most recent Annual Report on Form 10-K and any current and periodic reports filed with the U.S. Securities and Exchange Commission.Investor and Media ContactIDEAYA Biosciences
Joshua Bleharski, Ph.D.
Chief Financial Officer
investor@ideayabio.com IDEAYA Biosciences, Inc.Condensed Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts)
Three Months Ended
Year Ended
December 31,
December 31,
2025
2024
2025
2024
(Unaudited)
(Unaudited)
Collaboration revenue
$10,876
$7,000
$218,710
$7,000
Operating expenses:
Research and development
86,599
140,183
314,704
294,673
General and administrative
18,847
10,955
63,319
39,302
Total operating expenses
105,446
151,138
378,023
333,975
Loss from operations
(94,570)
(144,138)
(159,313)
(326,975)
Interest income and other income,
net
11,297
13,826
45,615
52,498
Net loss
(83,273)
(130,312)
(113,698)
(274,477)
Unrealized gains (losses) on
marketable securities
215
(3,024)
1,455
250
Comprehensive loss
$(83,058)
$(133,336)
$(112,243)
$(274,227)
Net loss per share
attributable to common
stockholders, basic and diluted
$(0.94)
$(1.49)
$(1.28)
$(3.36)
Weighted-average number of shares
outstanding, basic and diluted
88,582,694
87,340,758
88,485,238
81,678,069
IDEAYA Biosciences, Inc.Condensed Balance Sheet Data(in thousands)
December 31,
December 31,
2025
2024
(Unaudited)
Cash and cash equivalents and short-term and
long-term marketable securities
$1,049,685
$1,082,151
Total assets
1,109,324
1,124,091
Total liabilities
86,390
64,944
Total liabilities and stockholders' equity
1,109,324
1,124,091
View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-reports-fourth-quarter-and-full-year-2025-financial-results-and-provides-a-business-update-302688513.htmlSOURCE IDEAYA Biosciences, Inc.
Original: IDEAYA Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides a Business Update
US Market News
4月前
IDEAYA Biosciences to Participate in Upcoming February 2026 Investor Relations EventsFebruary 2, 2026 6:00 AM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif., Feb. 2, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in the upcoming investor relations events.
Citi's 2026 Virtual Oncology Leadership Summit
Wednesday, February 18th, 2026 at 1:00 PM ETFireside chat with Darrin Beaupre, Chief Medical Officer; Michael White, Chief Scientific Officer; and Joshua Bleharski, Chief Financial Officer, hosted by Yigal D. Nochomovitz, Ph.D., Director, SMid Cap Biotech AnalystIDEAYA Biosciences' Virtual Fireside Chat hosted by Umer Raffat of Evercore ISI
Monday, February 23rd, 2026 at 12:00 PM ETFireside chat with Yujiro S. Hata, President and Chief Executive Officer; Darrin Beaupre, Chief Medical Officer; Michael White, Chief Scientific Officer; and Joshua Bleharski, Chief Financial Officer, hosted by Umer Raffat, Senior Managing Director, Biotech and Pharma Equity Research.A live audio webcast of the events will be available under the "Investors/Events" section of the IDEAYA website at https://ir.ideayabio.com/events and/or through the conference host. A replay of the webcasts will be accessible for 30 days following the live events.About IDEAYA BiosciencesIDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.Forward-Looking StatementsThis press release contains forward-looking statements, including, but not limited to, statements related to participation in and/or presentation at certain investor relations events. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's current and future filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K filed on February 18, 2025.Investor and Media Contact
IDEAYA Biosciences
Joshua Bleharski, Ph.D.
Chief Financial Officer
investor@ideayabio.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-to-participate-in-upcoming-february-2026-investor-relations-events-302675666.htmlSOURCE IDEAYA Biosciences, Inc.
Original: IDEAYA Biosciences to Participate in Upcoming February 2026 Investor Relations Events
xr_biotech_consult
7年前
"We have made significant progress on our Phase 1/2 tissue-agnostic basket trial evaluating IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations, including metastatic uveal melanoma (MUM), cutaneous melanoma and colorectal cancer. This clinical trial progress, considered together with recent FDA feedback providing guidance on the regulatory pathway for IDE196 for treatment of MUM, are important enabling steps to advance this clinical-stage program," said Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences.
IDEAYA continues to advance its MAT2A synthetic lethality program to treat patients having tumors with MTAP deletion. The Company remains committed to the research and development of a differentiated MAT2A inhibitor that could meaningfully enhance patient outcomes across a broad range of indications. IDEAYA also continues to progress its broad pipeline of synthetic lethality programs, including Pol theta for patients having tumors with BRCA or other homologous recombination deficiency (HRD) mutations, and Werner (WRN) for patients having tumors with high microsatellite instability (MSI).
Key highlights for IDEAYA's research and development programs include:
Clinical Program IDE196
IDE196
Advanced IDEAYA's Phase 1/2 tissue-type agnostic basket trial, which was initiated in June 2019 to evaluate IDE196 in solid tumors harboring activating GNAQ/11 mutations, and is entitled "A phase 1/2 study of IDE196 in patients with solid tumors harboring GNAQ/11 mutations or PRKC fusions" (ClinicalTrials.gov Identifier: NCT03947385)
Completed enrollment in the Phase 1 dose escalation portion of the Phase 1/2 clinical trial at sites in the U.S. and Australia
Anticipate selection of the dosing regimen and initiation of the Phase 2 portion of the clinical trial by year-end 2019
Expect to introduce a tablet formulation of IDE196 in Q1 2020 for use in the Phase 2 portion of the clinical trial
Enrolled our first cutaneous melanoma patient harboring a tumor with an activating GNAQ/GNA11 mutation in October 2019, a key milestone for evaluating IDE196 in solid tumors outside of metastatic uveal melanoma (MUM)
Expanded our relationship with Foundation Medicine, participating in their Smart Trials™ program for identification of non-MUM patients having tumors with activating GNAQ/11 mutations for potential enrollment in our Phase 1/2 basket trial
Anticipate release of interim data from the Phase 1/2 basket trial in Q2/Q3 2020
Obtained FDA feedback in End-of-Phase 1 meeting in Q4 2019, providing guidance on the regulatory pathway for IDE196 for treatment of MUM
Company's proposed single-arm Phase 2 IDE196-001 clinical trial may be adequate to support an NDA seeking Accelerated Approval for IDE196 monotherapy in metastatic uveal melanoma (MUM)
The single-arm potentially registration-enabling Phase 2 clinical trial will target enrollment of 60 evaluable MUM patients
The primary endpoint is overall response rate (ORR) as determined by blinded independent central review (BICR), supported by BICR-determined duration of response (DOR) as a secondary endpoint
The 13-week GLP-compliant toxicology studies in 2 species is scheduled to initiate in November 2019, in support of FDA requirement that study results be submitted prior to enrollment of more than approximately 50 patients in the investigational arm of the clinical trial that will support a marketing application
Continued the ongoing Phase 1 clinical trial, entitled "A Phase I, multi-center, open-label, study of LXS196, an oral protein kinase C inhibitor, in patients with metastatic uveal melanoma" (ClinicalTrials.gov Identifier: NCT02601378), being conducted by Novartis
A confirmed Complete Response at the 200 mg BID dose level was observed at month 31 in one of four patients previously reported with confirmed Partial Response out of 30 total (28 evaluable) BID patients in this ongoing monotherapy arm of the Novartis clinical trial
Based on confirmation of the single arm trial design and anticipated rate of enrollment, we are anticipating submission of a New Drug Application (NDA) to the FDA in Q4 2021 to Q1 2022 for IDE196 in MUM.
Synthetic Lethality Preclinical Pipeline
MAT2A
We believe that data presented at the AACR/NCI/EORTC conference in October 2019 demonstrates clinical activity of MAT2A as a biological target in patients having tumors with MTAP deletion.
Continuing our preclinical evaluation of potential drug candidates, including in the HCT116 engineered in-vivo model, and in multiple endogenous in-vivo models
Goal is to select a MAT2A inhibitor development candidate in the first half of 2020 with differentiated properties relative to Agios' presented published compounds and Agios' publicly-disclosed properties of AG270
Expect to file an IND for a differentiated MAT2A inhibitor development candidate in second half of 2020
"We continue to aggressively progress our programs, expand our capabilities and enhance our team. IDEAYA remains committed to its vision of improving lives through transformative precision medicines, and believes that the IDE196 tissue-type agnostic basket trial and our pipeline of synthetic lethality programs are key elements of this goal," said Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences.
Corporate Updates
IDEAYA anticipates that existing cash, cash equivalents and short-term marketable securities of $109.4 million (as of September 30, 2019) will be sufficient to fund planned operations into the third quarter of 2021.
Financial Results
As of September 30, 2019, IDEAYA had cash, cash equivalents and short-term marketable securities totaling $109.4 million. This compared to cash, cash equivalents and short-term marketable securities of $90.0 million at December 31, 2018. The increase was primarily due to the receipt of $50.2 million in net proceeds from IDEAYA's initial public offering, which was completed in May 2019, offset by cash used in operations.
Research and development expenses for the three months ended September 30, 2019 totaled $8.9 million compared to $12.5 million for the same period in 2018. The decrease was primarily due to license fees for our IDE196 license agreement with Novartis during the three months ended September 30, 2018, offset by an increase in costs in connection with IDEAYA's Phase 1/2 clinical trial to evaluate IDE196 in solid tumors, and costs for personnel, consulting, and laboratory supplies in support of our research programs during the three months ended September 30, 2019.
General and administrative expenses for the three months ended September 30, 2019 totaled $2.7 million compared to $1.1 million for the same period in 2018. The increase was primarily due to an increase in costs for personnel, directors' and officers' liability insurance premiums, and professional fees in connection with becoming a publicly traded company as well as external legal patent expenses for our product candidates.
The net loss for the three months ended September 30, 2019 was $11.0 million compared to $13.0 million for the same period in 2018. Total stock compensation expense for the three months ended September 30, 2019 was $0.5 million compared to $0.3 million for the same period in 2018.
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