US Market News
1週前
Actinium Presents New ATNM-400 Data in KRAS and EGFR Mutant Models at SNMMI 2026 Supporting a Mutation-Agnostic Opportunity In Non-Small Cell Lung CancerJune 3, 2026 8:00 AM
PR Newswire (US) New KRAS-mutant data show ATNM-400 outperformed standard-of-care inhibitors sotorasib and adagrasib as a monotherapy. Treatment with these agents increased expression of the ATNM-400 target greater than 3.5x and enhanced their effect in combination
Additional data in the EGFR-mutant setting demonstrated powerful synergy with osimertinib due to enhanced target expression in treated animals resulting in complete tumor regression in the combination arm
The data with EGFR and KRAS mutations which account for approximately 40-50 percent of all NSCLC cases provide compelling evidence of the potential of ATNM-400 as a monotherapy or in combination with inhibitory agents against these mutations
ATNM-400 is a radioconjgate comprising an antibody coupled to Actinium-225 which causes cell death via double stranded DNA breaks independent of cellular mechanisms and offers broad potential as a mutation agnostic agent in NSCLC where its target is expressed in over 90 percent of tumors with greater expression as resistance emergesNEW YORK, June 3, 2026 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, on June 2, 2026, presented new preclinical data on ATNM-400 in non-small cell lung cancer (NSCLC) at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting in Los Angeles, California.The new KRAS-mutant data, together with a growing body of EGFR-mutant data, demonstrate ATNM-400's activity across the two major mutation driver classes in NSCLC and support a distinct strategic opportunity. ATNM-400 can be developed as a potential mutation-agnostic backbone for the broader NSCLC market, alone or in combination with standard-of-care therapies, rather than as another mutation-specific drug for a narrow subset.NSCLC accounts for roughly 85% of the more than two million lung cancer cases diagnosed globally each year, a market more than twice the size of prostate cancer. It is also highly heterogeneous: no single mutation dominates, so treatments are fragmented across mutation-specific therapies such as EGFR, KRAS, BRAF, ALK and others, each marketed by different companies, each addressing only a molecular subset, and each ultimately limited by acquired resistance. ATNM-400, Actinium's first-in-class Actinium-225 (Ac-225) antibody radioconjugate, is designed to break out of that single-mutation paradigm. Rather than blocking a specific mutant protein, it delivers a high-linear-energy-transfer alpha-particle payload that induces dense, irreversible double-strand DNA breaks and tumor-cell death independent of a tumor's driver mutation or signaling pathway, the mechanistic basis of its mutation-agnostic activity.ATNM-400's target antigen, from previously published immunohistochemistry studies, is present in approximately 98% of NSCLC tumors and highly expressed in approximately 70% of those tumors. It is conserved across EGFR-, KRAS-, and other driver-defined subgroups, and further increased in tumors that have become resistant to EGFR, KRAS, and immune-checkpoint therapies. In new KRAS-mutant studies presented at SNMMI, sotorasib (active ingredient in LUMAKRAS®/Amgen) and adagrasib (active ingredient in KRAZATI®/BMS) increased ATNM-400's target up to 3.5- and 3.8-fold, respectively, and adding ATNM-400 deepened tumor-cell killing beyond either inhibitor alone. These results demonstrate the same target-expression increasing, synergy-enabling biology shown previously with the EGFR inhibitor osimertinib, which produced tumor growth inhibition of 107% when combined with ATNM-400.These combination benefits also broaden ATNM-400's commercial opportunity. The franchises it could enhance are substantial; the KRAS inhibitor class in NSCLC is projected to exceed $5 billion in peak sales, and the EGFR-mutant segment has peak sales estimates over $15 billion, led by osimertinib (active ingredient in TAGRISSO®/AZ), which generated $7.3 billion in 2025. This positions ATNM-400 to participate in these established markets by enhancing the standard of care, while also reaching the broader NSCLC population beyond any single mutation.Sandesh Seth, Actinium's Chairman and CEO, said, "Today's data further strengthen our conviction that ATNM-400 represents a fundamentally different approach to treating NSCLC solid tumors. While most targeted therapies are designed for a single mutation-defined patient population, ATNM-400 combines the mutation-independent cell-killing power of Actinium-225 with a target that is broadly expressed across tumors and becomes even more abundant as resistance emerges. The consistency of activity we have now demonstrated across both EGFR- and KRAS-driven NSCLC supports our vision for ATNM-400 as a potential mutation-agnostic backbone therapy that can be used alone or in combination across large patient populations. We believe this opportunity could extend beyond lung cancer and may position ATNM-400 as a foundational therapy across multiple solid tumor indications."Highlights from the SNMMI 2026 Poster PresentationPoster Titled: ATNM-400: A First-in-Class Actinium-225 Antibody Radioconjugate Demonstrating Durable, Mutation-Agnostic Anti-Tumor Activity in Non-Small Cell Lung Cancer ModelsNew data demonstrated ATNM-400's potential as a mutation-agnostic antibody radioconjugate therapy for NSCLC:Across a panel of four lung cancer cell lines spanning EGFR- and KRAS-driver mutations, ATNM-400 bound and was internalized specifically by the three target-positive lines (NCI-H1975, NCI-H358 and Calu-3) but not by the target-negative line (A549), confirming that its activity is driven by target expression rather than by any particular mutation.In a KRAS G12C model (NCI-H358), PET imaging of radiolabeled ATNM-400 showed the drug concentrating in the tumor with low uptake in healthy tissue, visually confirming that it reaches its target in a living animal and delivers its alpha payload where intended while largely sparing normal organs.In a KRAS G13D model (Calu-3), a single dose of ATNM-400 drove tumor regression (124% and 135% inhibition at two dose levels), indicating marked antitumor potencywith full body-weight recovery. Deep responses from one dose with a clean tolerability profile point to a wide therapeutic window and dosing flexibility, favorable attributes for clinical translation.Treatment with both approved KRAS inhibitors (sotorasib and adagrasib) raised ATNM-400's target expression dose-dependently—up to roughly 3.5- to 3.8-fold—reaching statistical significance at every dose (p < 0.0001). The effect occurred with both agents, indicating a class-wide consequence of KRAS G12C inhibition that builds a rationale for combining ATNM-400 with these therapies.ATNM-400 plus sotorasib or adagrasib decreased cancer-cell viability beyond either inhibitor alone. The data demonstrate that ATNM-400 has development potential not only as a monotherapy but also in combination with these leading KRAS therapies and possibly the entire KRAS-mutant class.In an EGFR-mutant model (NCI-H1975), ATNM-400 monotherapy achieved 75% tumor growth inhibition versus 40% for osimertinib; combined with osimertinib it reached 107% inhibition with complete cures in 100% of mice. Osimertinib raised target expression, providing a clear rationale for the combination.About Actinium Pharmaceuticals, Inc.Actinium is a pioneer in targeted radiotherapies designed to improve outcomes for patients with cancer. The company employs a biology-driven approach to develop differentiated radiopharmaceuticals for solid tumors and hematologic malignancies. Its mission is to transform cancer treatment through innovative radioconjugates that maximize therapeutic efficacy while minimizing toxicity to healthy tissue by combining expertise in tumor biology, translational medicine, and radiochemistry. Since inception, Actinium has focused on developing innovative radiotherapies. Its pipeline reflects this strategy across three areas: (1) solid tumor therapeutics including ATNM-400 and Actimab-A with pan-tumor potential; (2) Actimab-A as a therapeutic backbone for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in collaboration with the National Cancer Institute (NCI); and (3) targeted conditioning agents including Iomab-B for bone marrow transplant and Iomab-ACT for cell and gene therapy conditioning. ATNM-400 targets a novel antigen distinct from PSMA and has demonstrated preclinical activity across metastatic castration-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), and breast cancer. Actimab-A has shown improved survival in relapsed/refractory AML with CLAG-M and is advancing toward a Phase 2/3 trial, with additional development ongoing through a CRADA with the NCI. Actinium is also advancing preclinical solid tumor programs and holds approximately 250 patents and patent applications, including intellectual property related to cyclotron-based production of Ac-225. For more information, please visit www.actiniumpharma.com.Forward-Looking StatementsThis press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements, including statements as related to regaining compliance with the rules of the NYSE American and submission of a compliance plan, are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on Form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.Investors: investorrelations@actiniumpharma.com View original content to download multimedia:https://www.prnewswire.com/news-releases/actinium-presents-new-atnm-400-data-in-kras-and-egfr-mutant-models-at-snmmi-2026-supporting-a-mutation-agnostic-opportunity-in-non-small-cell-lung-cancer-302789401.htmlSOURCE Actinium Pharmaceuticals, Inc. Original: Actinium Presents New ATNM-400 Data in KRAS and EGFR Mutant Models at SNMMI 2026 Supporting a Mutation-Agnostic Opportunity In Non-Small Cell Lung Cancer
US Market News
2週前
Actinium Pharmaceuticals to Present ATNM-400 Program Update at SNMMI 2026 Conference on May 31-June 2 and Provides NYSE American Listing Standards NoticeMay 29, 2026 5:30 PM
PR Newswire (US) NEW YORK, May 29, 2026 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, today announced it will provide a program update on its first-in-class Actinium-225 (225Ac) antibody radioconjugate, ATNM-400, highlighting new data that will be showcased across three presentations at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting, taking place May 30-June 2, 2026, in Los Angeles, California. Two of the presentations showcase ATNM-400's differentiated profile across prostate cancer and non-small cell lung cancer (NSCLC), while a third demonstrates the importance of radioconjugate optimization for radiotherapies in the context of the Company's pipeline candidates. With the SNMMI 2026 program now finalized, the Company is providing updated presentation details, including poster titles, presenters, dates, and times. The data to be presented reinforce the meaningful progress of the ATNM-400 program and its potential as a mutation-agnostic, pan-tumor therapy, while also demonstrating the strength of the underlying radioconjugate platform that supports Actinium's broader pipeline. The Company anticipates multiple catalysts for ATNM-400, Actimab-A and Iomab-ACT in 2H:2026 that are expected to demonstrate the clinical potential of these programs.ATNM-400 SNMMI 2026 Presentation DetailsPoster Title: ATNM-400: A First-in-Class Non-PSMA Actinium-225 Antibody Radioconjugate Demonstrates Superior Efficacy to PSMA-617 Radioligands and ARPIs With Favorable Safety Profile in Prostate Cancer Models
Presenter: Sumit Mukherjee Ph.D., Actinium Pharmaceuticals, Inc.
Session: Oncology: Discovery & Translational Meet the Author Session
Date & Time: Tuesday, June 2, 2026 11:30am-12:15pm PT | Los Angeles, CaliforniaPoster Title: ATNM-400: A First-in-Class Actinium-225 Antibody Radioconjugate Demonstrating Durable, Mutation-Agnostic Anti-Tumor Activity in Non-Small Cell Lung Cancer Models
Presenter: Shiva Kazerounian Ph.D., Actinium Pharmaceuticals, Inc.
Session: Oncology: Discovery & Translational Meet the Author Session
Date & Time: Tuesday, June 2, 2026, 11:30am-12:15pm PT | Los Angeles, CaliforniaPoster Title: Optimizing Chelator-to-Antibody Ratio Improves Tumor Targeting and Pharmacokinetics of 225Ac-Labeled Antibodies
Presenter: Shiva Kazerounian Ph.D., Actinium Pharmaceuticals, Inc.
Session: MTA05 RPSC/CMIIT POPs and Science Pavilion Mixer
Date & Time: Sunday, May 31, 2026, 7:30-8:00pm PT | Los Angeles, CaliforniaThe posters will be available on the Company website shortly after the presentations at https://ir.actiniumpharma.com/presentations-webinars.NYSE American Continued Listing Standards Notice
Actinium also announced today that it has received a notice (the "Notice") from the NYSE American LLC ("NYSE American") indicating that the Company is not in compliance with the continued listing standards set forth in Section 1003(a)(ii) of the NYSE American Company Guide (the "Company Guide"), which requires a listed company to maintain stockholders' equity of $4.0 million or more if it has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years. As of March 31, 2026, the Company reported stockholders' equity of approximately $2.3 million and had net losses in its last five fiscal years ended December 31, 2025. The Notice also indicates that the Company is also not currently eligible for any exemption in Section 1003(a) of the Company Guide. The notice has no immediate effect on the listing or trading of the Company's common stock on the NYSE American and the Company's shares will continue to trade under the symbol "ATNM," subject to compliance with other listing requirements of the Company Guide.In connection with the non-compliance with Sections 1003(a)(ii) and (iii) of the Company Guide, the Company must submit a compliance plan by June 26, 2026, advising of actions the Company has taken or will take to regain compliance with the continued listing standards by November 27, 2027 (the "Plan Period Deadline"). If the NYSE American determines to accept the plan, the Company will be notified in writing and will be subject to periodic reviews, including quarterly monitoring, for compliance with the plan.If the Company does not submit a plan or if the plan is not accepted, delisting proceedings will commence. Furthermore, if the plan is accepted but the Company is not in compliance with the continued listing standards by the Plan Period Deadline which is eighteen months from the receipt of the notice or November 27, 2027, or if the Company does not make progress consistent with the plan during the plan period, Exchange staff will initiate delisting proceedings as appropriate. The Company may appeal a staff delisting determination in accordance with Section 1010 and Part 12 of the Company Guide.Actinium currently intends to submit a plan to regain compliance within the required timeframe. There can be no assurance that the Company will be able to achieve compliance with the NYSE American's continued listing standards within the required timeframe of eighteen months from date of receipt of the notice or November 27, 2027.About Actinium Pharmaceuticals, Inc.Actinium is a pioneer in targeted radiotherapies designed to improve outcomes for patients with cancer. The company employs a biology-driven approach to develop differentiated radiopharmaceuticals for solid tumors and hematologic malignancies. Its mission is to transform cancer treatment through innovative radioconjugates that maximize therapeutic efficacy while minimizing toxicity to healthy tissue by combining expertise in tumor biology, translational medicine, and radiochemistry. Since inception, Actinium has focused on developing innovative radiotherapies. Its pipeline reflects this strategy across three areas: (1) solid tumor therapeutics including ATNM-400 and Actimab-A with pan-tumor potential; (2) Actimab-A as a therapeutic backbone for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in collaboration with the National Cancer Institute (NCI); and (3) targeted conditioning agents including Iomab-B for bone marrow transplant and Iomab-ACT for cell and gene therapy conditioning. ATNM-400 targets a novel antigen distinct from PSMA and has demonstrated preclinical activity across metastatic castration-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), and breast cancer. Actimab-A has shown improved survival in relapsed/refractory AML with CLAG-M and is advancing toward a Phase 2/3 trial, with additional development ongoing through a CRADA with the NCI. Actinium is also advancing preclinical solid tumor programs and holds ~250 patents and patent applications, including intellectual property related to cyclotron-based production of Ac-225. For more information, please visit www.actiniumpharma.com.Forward-Looking Statements
This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements, including statements as related to regaining compliance with the rules of the NYSE American and submission of a compliance plan, are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.Investors: investorrelations@actiniumpharma.com View original content to download multimedia:https://www.prnewswire.com/news-releases/actinium-pharmaceuticals-to-present-atnm-400-program-update-at-snmmi-2026-conference-on-may-31-june-2-and-provides-nyse-american-listing-standards-notice-302786103.htmlSOURCE Actinium Pharmaceuticals, Inc. Original: Actinium Pharmaceuticals to Present ATNM-400 Program Update at SNMMI 2026 Conference on May 31-June 2 and Provides NYSE American Listing Standards Notice
US Market News
2週前
Actinium Pharmaceuticals Receives Two Patent Allowances Spanning Its Actimab-A and Iomab-ACT ProgramsMay 29, 2026 5:31 PM
PR Newswire (US) Together the allowances deepen protection across two priority franchises and reinforce a patent estate of approximately 250 issued and pending patents and patent applications worldwideNEW YORK, May 29, 2026 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, today announced that the Canadian Intellectual Property Office (CIPO) has issued Notices of Allowance for two patent applications spanning the Company's Actimab-A and Iomab-ACT programs. The allowances broaden Actinium's intellectual property protection across both hematologic malignancies and next-generation conditioning for gene-edited cell-based therapies in Canada, an important market within the Company's growing global patent estate. These Canadian allowances build on protection already secured in other major markets, including a previously granted Japanese patent for the Actimab-A program and an issued U.S. patent for the Iomab-ACT program, with additional applications pending in the United States, Europe and China. The Notices of Allowance follow examination by CIPO, with issuance of the patents expected in the ordinary course. The allowances deepen Actinium's intellectual property protection across two of its priority franchises and reinforce a global patent estate of approximately 250 issued and pending patents and patent applications."These two allowances reflect the breadth and depth of the innovation across our radiotherapy platform and our commitment to protecting it in every key market," said Adeela Kamal, Ph.D., EVP-R&D of Actinium Pharmaceuticals. "Securing coverage for both our Actimab-A CLAG-M combination in AML and our Iomab-ACT conditioning approach for gene-edited cell-based therapies underscores the strength of our science and the durability of the franchises we are building. We will continue to expand and defend our intellectual property worldwide as we advance these programs toward patients."Actimab-A + CLAG-M Combination for AMLThe allowed application covers the use of Actimab-A in combination with the CLAG-M chemotherapy regimen for the treatment of AML. Actimab-A is one of Actinium's most advanced clinical-stage candidates and may serve as a therapeutic backbone for myeloid malignancies. The Canadian allowance complements a counterpart patent already granted in Japan, with applications pending in the United States and Europe. The Canadian patent issuing from Application No. 3,087,346 titled "Combination Immunotherapy and Chemotherapy for the Treatment of a Hematological Malignancy" will have a patent term running into January 2039.Iomab-ACT for Gene-Edited Cell-Based TherapiesThe allowed application covers Actinium's targeted CD45 conditioning approach used to prepare patients for gene-edited cell-based therapies. Iomab-ACT is designed as a targeted conditioning agent intended to enable adoptive cell therapies. The Canadian allowance builds on a patent already granted in the United States, with additional applications pending in the United States, Europe and China. The Canadian patent issuing from Application No. 3,078,963 titled "Anti-CD45-Based Conditioning Methods and Uses Thereof in Conjunction with Gene-Edited Cell-Based Therapies" will have a patent term running into October 2038.About Actinium Pharmaceuticals, Inc.Actinium is a pioneer in targeted radiotherapies designed to improve outcomes for patients with cancer. The company employs a biology-driven approach to develop differentiated radiopharmaceuticals for solid tumors and hematologic malignancies. Its mission is to transform cancer treatment through innovative radioconjugates that maximize therapeutic efficacy while minimizing toxicity to healthy tissue by combining expertise in tumor biology, translational medicine, and radiochemistry. Since inception, Actinium has focused on developing innovative radiotherapies. Its pipeline reflects this strategy across three areas: (1) solid tumor therapeutics including ATNM-400 and Actimab-A with pan-tumor potential; (2) Actimab-A as a therapeutic backbone for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in collaboration with the National Cancer Institute (NCI); and (3) targeted conditioning agents including Iomab-B for bone marrow transplant and Iomab-ACT for adoptive cell therapy conditioning. ATNM-400 targets a novel antigen distinct from PSMA and has demonstrated preclinical activity across metastatic castration-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), and breast cancer. Actimab-A has shown improved survival in relapsed/refractory AML with CLAG-M and is advancing toward a Phase 2/3 trial, with additional development ongoing through a CRADA with the NCI. Actinium is also advancing preclinical solid tumor programs and holds ~250 patents and patent applications, including intellectual property related to cyclotron-based production of Ac-225. For more information, please visit www.actiniumpharma.com. Forward-Looking StatementsThis press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements, including statements as related to regaining compliance with the rules of the NYSE American and submission of a compliance plan, are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.Investors: investorrelations@actiniumpharma.com View original content to download multimedia:https://www.prnewswire.com/news-releases/actinium-pharmaceuticals-receives-two-patent-allowances-spanning-its-actimab-a-and-iomab-act-programs-302786081.htmlSOURCE Actinium Pharmaceuticals, Inc. Original: Actinium Pharmaceuticals Receives Two Patent Allowances Spanning Its Actimab-A and Iomab-ACT Programs
US Market News
2月前
Actinium Highlights Transcriptional Reprogramming as a Key Mechanism Underpinning Mutation-Agnostic Activity of Actimab-A in AML at the 2026 American Association of Cancer Research Annual MeetingApril 22, 2026 7:00 AM
PR Newswire (US)
Actimab-A combinations enhanced in vivo AML cell killing across multiple preclinical models, independent of mutation status, when combined with standard-of-care targeted and non-targeted therapies including revumenib (menin-KMT2A inhibitor), gilteritinib (FLT3 inhibitor), and azacitidine (hypomethylating agent) - three pillars of modern AML treatment - supporting its potential role as a universal combination backboneTranscriptional reprogramming identified as a central mechanism showing that Actimab-A combinations don't just add cytotoxicity, they reprogram AML cells from proliferation toward differentiation and apoptosis, providing the mechanistic basis for deeper, more durable MRD-negative responses and reinforcing Actimab-A's role as a universal combination backbone across AMLRobust cytotoxicity observed in primary AML patient samples across key mutations (FLT3, KMT2A, NPM1, IDH1, IDH2, or TP53), reinforcing Actimab-A's potential as a mutation-agnostic backbone therapy, complementing the manageable safety profile of Actimab-A observed across prior clinical trials in over 150 AML patientsNEW YORK, April 22, 2026 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, today highlighted data presented at the American Association for Cancer Research (AACR) Annual Meeting supporting transcriptional reprogramming as a central mechanism driving the mutation-agnostic anti-leukemic activity of Actimab-A (lintuzumab-Ac225) in acute myeloid leukemia (AML).Preclinical translational data demonstrated that lintuzumab-Ac225 delivers potent cytotoxic activity across AML models harboring common mutations, including FLT3, NPM1, KMT2A, and TP53, as well as in primary patient samples. Importantly, combining Actimab-A with standard-of-care therapies - the menin inhibitor revumenib, the FLT3 inhibitor gilteritinib, and the hypomethylating agent azacitidine - resulted in enhanced leukemic cell killing in vivo across all tested models, independent of mutation status. These results support a combination-driven clinical strategy aimed at improving depth and durability of response. The findings provide the mechanistic foundation for Actimab-A's observed clinical activity and, together with the manageable safety profile demonstrated across prior Actimab-A trials in more than 150 AML patients, reinforce its suitability as a combination backbone across multiple treatment settings.Actimab-A is Actinium's lead clinical radiotherapy delivering Actinium-225, a potent alpha-emitter radioisotope payload that produces lethal double-strand DNA breaks to kill CD33-expressing AML cells. CD33 is expressed ubiquitously in AML and other myeloid malignancies. Actimab-A has been evaluated in more than 150 AML patients across multiple treatment settings, including as monotherapy and in combination with the chemotherapy regimen CLAG-M and with the BCL-2 inhibitor venetoclax, where it has demonstrated compelling clinical activity and a manageable safety profile. Under our Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), Actimab-A is being advanced through the NCI's National Clinical Trials Network, including an ongoing frontline triplet trial combining Actimab-A with venetoclax and the hypomethylating agent ASTX-727 in newly diagnosed AML patients. The data presented at AACR 2026 further support Actimab-A's mutation-agnostic mechanism of action and its synergistic activity with targeted therapies approved for patients with the most commonly expressed AML mutations.Key Data and Highlights of the Actimab-A AACR PresentationNew data on Actimab-A's mechanism and combination potential in primary AML patient samples further support its positioning as a foundational backbone therapy across multiple AML treatment settings, significantly expanding its commercial opportunity across the AML treatment continuum. In the relapsed/refractory AML setting Actimab-A in combination with the intensive chemotherapy regimen CLAG-M produced an 83% overall response rate and 75% MRD-negativity in a Phase 1 trial which forms the basis of a Phase 2/3 registrational study for which Actinium has FDA alignment and is seeking a development partner. Actimab-A is also being studied in newly diagnosed patients via the ongoing NCI-sponsored frontline triplet trial of Actimab-A with venetoclax and ASTX-727; and has shown promise in post-remission and MRD-directed settings; as well as myelodysplastic syndrome (MDS) and other CD33-expressing myeloid malignancies.Transcriptional Reprogramming as a Key Mechanism for Actimab-A Combination ActivityCombination treatment produced consistent pathway-level changes compared with monotherapy. Gene set enrichment analyses (GSEA) showed enhanced myeloid differentiation signatures with the addition of Actimab-A (lintuzumab-Ac225) to revumenib, gilteritinib, and azacitidine.Across models, combinations were associated with downregulation of proliferative programs, including MYC target genes, E2F targets, and G2/M checkpoint signatures, together with enrichment of p53-associated stress response and apoptosis pathways.Together, these findings show that Actimab-A combinations don't just add cytotoxicity — they reprogram AML cells from proliferation toward differentiation and apoptosis, providing the mechanistic basis for deeper, more durable MRD-negative responses and reinforcing Actimab-A's role as a universal combination backbone across AML.Broad Activity of Actimab-A as Monotherapy and in Combination in Primary AML Patient SamplesActimab-A (LinT-Ac225) showed robust cytotoxicity in primary AML patient samples, independent of FLT3, KMT2A, NPM1, IDH1, IDH2, or TP53 mutation status, positioning Actimab-A to treat the full AML population, including TP53-mutant patients who lack effective targeted options, and to serve as a universal combination partner rather than a mutation-restricted therapy.Combining standard-of-care therapies (SOC) – revumenib (menin-KMT2A inhibitor), gilteritinib (FLT3 inhibitor), and azacitidine (hypomethylating agent) – with Actimab-A enhanced anti-leukemic efficacy across models - demonstrating synergy with one drug from each of the three pillars of modern AML care (targeted kinase inhibitors, menin inhibitors, and hypomethylating agents) and supporting Actimab-A's positioning as a universal combination partner across frontline, relapsed/refractory, and unfit AML populations.Sandesh Seth, Actinium's Chairman and CEO, said, "The data presented at AACR 2026 represent a significant step forward in our mission to establish Actimab-A as the foundational backbone therapy across the AML treatment continuum. For the first time, we have clear molecular evidence – through transcriptional profiling – of how Actimab-A reprograms AML cells to activate p53-driven apoptosis and shut down proliferative signaling, providing the mechanistic basis for deeper, more durable MRD-negative responses and mutation-agnostic activity we have consistently observed clinically. As the only CD33-targeted radiotherapy in development for myeloid malignancies, Actimab-A uniquely leverages the broad, stable expression of CD33 and the potent, mutation-agnostic Ac-225 payload to complement – not compete with – the targeted therapies that define today's AML standard of care. Building on compelling clinical results across more than 150 patients in multiple treatment settings, and the high visibility of our NCI CRADA – including the ongoing frontline triplet trial with venetoclax and ASTX-727 – these findings will strengthen investigator enthusiasm for Actimab-A and reinforce the significant commercial opportunity ahead as we seek a partner for the registrational Phase 2/3 Actimab-A + CLAG-M study for which we have FDA alignment. We are focused on executing across our ongoing and planned clinical programs to deliver meaningful improvements in outcomes for AML patients, who continue to face high unmet medical need that is not addressed by currently available therapies."The Actimab-A AACR presentation is available for viewing on the Presentations & Webinars page of Actinium's website HERE.Title: Actimab-A, a CD33-Targeted Actinium-225 Radioconjugate, Drives Mutation-Agnostic Anti-Leukemic Activity and Synergizes with Standard Therapies in AML Through Transcriptional ReprogrammingAbstract Number: 5827About Actimab-AActimab-A (lintuzumab-Ac225) is Actinium's lead CD33-targeted radiotherapy and the only CD33-targeted radiotherapy in clinical development for myeloid malignancies. Actimab-A pairs a humanized anti-CD33 monoclonal antibody (lintuzumab) with the potent alpha-emitter Actinium-225 (Ac-225), which delivers high-energy, short-range radiation that produces lethal double-strand DNA breaks in CD33-expressing leukemic cells while sparing surrounding healthy tissue. Because CD33 is expressed on the blasts of the large majority of AML patients and the Ac-225 payload kills cells independent of genetic background, Actimab-A is positioned as a mutation-agnostic backbone that can be combined with the targeted and non-targeted therapies that define today's AML standard of care.Actimab-A has been studied in more than 150 patients with AML across multiple treatment settings, including as monotherapy and in combination with the intensive chemotherapy regimen CLAG-M and with the BCL-2 inhibitor venetoclax. In a Phase 1 trial in relapsed/refractory AML, Actimab-A plus CLAG-M produced an 83% overall response rate and 75% MRD-negativity at the recommended Phase 2 dose, with meaningful overall survival benefits in a high-risk population including patients with TP53 mutations and prior venetoclax exposure, and a manageable safety profile. Under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), Actimab-A is being advanced across the NCI's National Clinical Trials Network – which includes approximately 2,000 clinical trial sites through groups such as ECOG, SWOG, and Alliance – and is the subject of an ongoing frontline triplet combination trial with venetoclax and the hypomethylating agent ASTX-727 (Taiho Oncology) in newly diagnosed AML patients. Actimab-A is advancing toward a Phase 2/3 registrational program, with the goal of establishing Actimab-A as a foundational backbone therapy for patients with AML, myelodysplastic syndrome (MDS), and other CD33-expressing myeloid malignancies – a patient population that continues to face high unmet medical need.About Actinium Pharmaceuticals, Inc.Actinium is a pioneer in targeted radiotherapies designed to improve outcomes for patients with cancer. The company employs a biology-driven approach to develop differentiated radiopharmaceuticals for solid tumors and hematologic malignancies. Its mission is to transform cancer treatment through innovative radioconjugates that maximize therapeutic efficacy while minimizing toxicity to healthy tissue by combining expertise in tumor biology, translational medicine, and radiochemistry. Since inception, Actinium has focused on developing innovative radiotherapies. Its pipeline reflects this strategy across three areas: (1) solid tumor therapeutics including ATNM-400 and Actimab-A with pan-tumor potential; (2) Actimab-A as a therapeutic backbone for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in collaboration with the National Cancer Institute (NCI); and (3) targeted conditioning agents including Iomab-B for bone marrow transplant and Iomab-ACT for cell and gene therapy conditioning. ATNM-400 targets a novel antigen distinct from PSMA and has demonstrated preclinical activity across metastatic castration-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), and breast cancer. Actimab-A has shown improved survival in relapsed/refractory AML with CLAG-M and is advancing toward a Phase 2/3 trial, with additional development ongoing through a CRADA with the NCI. Actinium is also advancing preclinical solid tumor programs and holds ~250 patents and patent applications, including intellectual property related to cyclotron-based production of Ac-225. For more information, please visit www.actiniumpharma.com.For more information, please visit: https://www.actiniumpharma.com/Forward-Looking StatementsThis press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.Investors:
investorrelations@actiniumpharma.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/actinium-highlights-transcriptional-reprogramming-as-a-key-mechanism-underpinning-mutation-agnostic-activity-of-actimab-a-in-aml-at-the-2026-american-association-of-cancer-research-annual-meeting-302749761.htmlSOURCE Actinium Pharmaceuticals, Inc.
Original: Actinium Highlights Transcriptional Reprogramming as a Key Mechanism Underpinning Mutation-Agnostic Activity of Actimab-A in AML at the 2026 American Association of Cancer Research Annual Meeting
US Market News
2月前
Actinium Pharmaceuticals, Inc. Announces Compelling Pan-Tumor Data for ATNM-400 Demonstrating Broad Efficacy Across Prostate, Lung, and Breast Cancer Models at the 2026 American Association of Cancer Research Annual MeetingApril 22, 2026 7:00 AM
PR Newswire (US)
ATNM-400 demonstrates pan-tumor activity across prostate, lung, and breast cancer models, supporting multi-indication development potentialIn prostate cancer, ATNM-400 demonstrates efficacy across both high PSMA-expressing and, importantly, low PSMA-expressing prostate cancer models, unlike many PSMA-targeted radioligand therapies that work only in PSMA-high settingsIn EGFR-mutant non-small cell lung cancer, ATNM-400 demonstrates greater tumor growth inhibition than osimertinib (a tyrosine kinase inhibitor) plus chemotherapy and outperforms the approved Trop-2 ADC Dato-DXd (DATROWAY®), the EGFR-cMET bispecific antibody amivantamab (RYBREVANT®) and the experimental EGFR-HER3 ADC izalontamab brengitecan, supporting potential use across first-, second-, and third-line treatment settingsIn breast cancer, new head-to-head data shows ATNM-400 achieves efficacy comparable to the approved HER2-ADC trastuzumab deruxtecan (ENHERTU®) in trastuzumab-resistant models, with durable tumor control observed after treatment discontinuation - extending the Company's prior SABCS 2025 data and supporting potential for less frequent dosing of ATNM-400 compared to ADCsATNM-400 is well tolerated, with no in vivo toxicities observed at efficacious doses, providing a favorable therapeutic index that supports monotherapy and combination developmentNEW YORK, April 22, 2026 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, today announced preclinical results for ATNM-400 across prostate, lung, and breast cancer models presented at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA. ATNM-400 is a novel, first-in-class targeted radiotherapy utilizing the Actinium-225 (Ac-225) radioisotope that targets a non-PSMA membrane antigen overexpressed in advanced and therapy-refractory solid tumors across multiple oncology indications.ATNM-400 is a novel, first-in-class targeted radiotherapy whose differentiation stems from both its target and its isotope. The target is a non-PSMA membrane antigen associated with treatment resistance in advanced solid tumors that is overexpressed across prostate cancer, non-small cell lung cancer (NSCLC), and breast cancer, and is further upregulated following treatment with standard-of-care therapies — providing a strong mechanistic rationale for ATNM-400 in the treatment-resistant disease settings that represent the greatest unmet need, and for combination regimens designed to exploit this treatment-induced target upregulation. The isotope, Actinium-225 (Ac-225), is a potent alpha emitter that, compared to beta emitters such as Lu-177, delivers high-energy radiation capable of inducing irreversible double-stranded DNA breaks, with a shorter path length that may limit off-target effects and enhance therapeutic precision. Together, this target-and-isotope combination positions ATNM-400 to overcome conventional resistance pathways and deliver durable tumor control while potentially avoiding toxicities such as interstitial lung disease that limit the use of antibody-drug conjugates — expanding the population of patients who could benefit from treatment.Key Data and Highlights From the ATNM-400 AACR PresentationNew preclinical data support ATNM-400 as a differentiated Ac-225 radioconjugate with potential applicability across multiple high-value solid tumor indications. ATNM-400 demonstrates a favorable tolerability profile, with no significant toxicity observed at therapeutic doses; and additionally:In Prostate CancerDemonstrates in vivo efficacy across prostate cancer models with low, medium, and high PSMA expression, including PSMA-negative models.Shows superior anti-tumor efficacy versus vehicle control, unconjugated antibody, and 177Lu–PSMA-617 (active ingredient in PLUVICTO®) in both high -PSMA, (C4-2) and low (22Rv1) PSMA-expressing models, addressing both patients unlikely to respond to PSMA-targeted radioligand therapy (low-PSMA, 22Rv1) and those who relapse on it (C4-2).Activity in PSMA-negative (DU145) models supports a differentiated profile, suggesting ATNM-400 could address mCRPC patients who are ineligible for or have progressed on PSMA-targeted radioligand therapy due to low or absent PSMA expression— a population with no currently approved targeted radiotherapy option.In Lung CancerNew data in the NCI-H1975 EGFR-mutant NSCLC model - a clinically relevant model of osimertinib-resistant disease - shows ATNM-400 as monotherapy or in combination with osimertinib exceeds the tumor growth inhibition of osimertinib plus chemotherapy, the current standard of care in post-osimertinib progression. These results extend the Company's prior data demonstrating 100% complete tumor regression with the ATNM-400 plus osimertinib combination.ATNM-400 monotherapy demonstrates greater anti-tumor activity than Dato-DXd (TROP-2 ADC approved in EGFR-mutant lung cancer) and izalontamab brengitecan (HER3-EGFR bispecific ADC in development for EGFR-mutant lung cancer). ATNM-400 also demonstrates greater anti-tumor activity than the EGFR-cMET bispecific antibody amivantamab (RYBREVANT®) as shown in prior studies.In Breast CancerNew head-to-head data in the BT474 Clone-5 trastuzumab-resistant HER2+ breast cancer model which is a clinically relevant model of the post-trastuzumab setting, where treatment options are limited, demonstrate that ATNM-400, both as monotherapy and in combination with trastuzumab deruxtecan, achieves anti-tumor activity comparable to the approved HER2-ADC trastuzumab deruxtecan (ENHERTU®). These results extend the Company's SABCS 2025 data and position ATNM-400 as a potential alternative for patients who cannot tolerate HER2 ADCs due to interstitial lung disease, a known class-related toxicity.In the same post-trastuzumab failure setting, ATNM-400 produces durable tumor growth inhibition after treatment discontinuation which exceeds both vehicle control and trastuzumab deruxtecan, supporting the potential for less frequent dosing and more durable disease control than ADCs.Sandesh Seth, Actinium's Chairman and CEO, said, "The data we presented at AACR are an important new piece of a much larger picture for ATNM-400. As a single agent, ATNM-400 continues to demonstrate activity across prostate, lung, and breast cancer in the treatment-resistant settings that represent the greatest unmet need, and also in combinations which can expand the available opportunity to additional patient populations. These data build on our previously disclosed results showing significant tumor regression when ATNM-400 is combined with osimertinib in EGFR-mutant lung cancer, and when combined with enzalutamide in prostate cancer, with similar combination potential emerging in breast cancer. What is becoming increasingly clear is that ATNM-400's target antigen is upregulated by standard-of-care therapies, which creates a strong mechanistic rationale for ATNM-400 to rescue patients who progress approved agents and also to extend the benefit of these approved agents through combinations. We look forward to continuing to advance ATNM-400 toward the clinic with additional data to come in 2026."The ATNM-400 AACR presentation is available for viewing on the Presentations & Webinars page of Actinium's website HERE.Title: Preclinical Development of ATNM-400, a First-in-Class Actinium-225 Radioconjugate with Pan-Tumor Efficacy in Solid TumorsAbstract Number: 5824About Actinium Pharmaceuticals, Inc.Actinium is a pioneer in targeted radiotherapies designed to improve outcomes for patients with cancer. The company employs a biology-driven approach to develop differentiated radiopharmaceuticals for solid tumors and hematologic malignancies. Its mission is to transform cancer treatment through innovative radioconjugates that maximize therapeutic efficacy while minimizing toxicity to healthy tissue by combining expertise in tumor biology, translational medicine, and radiochemistry. Since inception, Actinium has focused on developing innovative radiotherapies. Its pipeline reflects this strategy across three areas: (1) solid tumor therapeutics including ATNM-400 and Actimab-A with pan-tumor potential; (2) Actimab-A as a therapeutic backbone for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in collaboration with the National Cancer Institute (NCI); and (3) targeted conditioning agents including Iomab-B for bone marrow transplant and Iomab-ACT for cell and gene therapy conditioning. ATNM-400 targets a novel antigen distinct from PSMA and has demonstrated preclinical activity across metastatic castration-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), and breast cancer. Actimab-A has shown improved survival in relapsed/refractory AML with CLAG-M and is advancing toward a Phase 2/3 trial, with additional development ongoing through a CRADA with the NCI. Actinium is also advancing preclinical solid tumor programs and holds ~250 patents and patent applications, including intellectual property related to cyclotron-based production of Ac-225. For more information, please visit www.actiniumpharma.com.For more information, please visit: https://www.actiniumpharma.com/ Forward-Looking StatementsThis press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.Investors:
investorrelations@actiniumpharma.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/actinium-pharmaceuticals-inc-announces-compelling-pan-tumor-data-for-atnm-400-demonstrating-broad-efficacy-across-prostate-lung-and-breast-cancer-models-at-the-2026-american-association-of-cancer-research-annual-meeting-302749720.htmlSOURCE Actinium Pharmaceuticals, Inc.
Original: Actinium Pharmaceuticals, Inc. Announces Compelling Pan-Tumor Data for ATNM-400 Demonstrating Broad Efficacy Across Prostate, Lung, and Breast Cancer Models at the 2026 American Association of Cancer Research Annual Meeting
US Market News
2月前
Actinium Pharmaceuticals Announces New Pan-Tumor Preclinical Data for ATNM-400 in Solid Tumors and Differentiated Mechanism for Actimab-A in AML to be Presented at 2026 AACR Annual MeetingApril 6, 2026 7:30 AM
PR Newswire (US)
New data underscoring the potential of ATNM-400 as a first-in-class Ac-225 radioconjugate with broad pan-tumor efficacy across multiple solid tumor models
Actimab-A demonstrates mutation-agnostic efficacy and a novel mechanism that enhances response to standard AML therapies
Multiple data catalysts for ATNM-400 and Actimab-A in 2026; and posters for each to be presented on April 21, 2026 at AACR 2026 in San Diego, CANEW YORK, April 6, 2026 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, today announced the publication of two abstracts that will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 17–22, 2026, in San Diego, California.
The Company will present previously undisclosed data demonstrating the expanding potential of its Ac-225 radiotherapy platform across both solid tumors and hematologic malignancies. Both presentations will occur on April 21, 2026 in the session Radiopharmaceutical Platforms for Theranostic Precision Oncology.Sandesh Seth, Actinium's Chairman and CEO, said, "These new data further validate the strength and versatility of our Ac-225 radiotherapy platform. ATNM-400 continues to show compelling pan-tumor activity, including activity in tumors resistant to current targeted therapies, supporting its potential as a first-in-class asset in large solid tumor indications. In parallel, Actimab-A's newly identified mechanism of transcriptional reprogramming provides important insight into its mutation-agnostic activity and ability to enhance standard-of-care therapies. Together, these findings reinforce our strategy to build a differentiated pipeline with multiple value-driving opportunities."ATNM-400 AACR 2026 Presentation DetailsPoster Number: 5824Session: Radiopharmaceutical Platforms for Theranostic Precision OncologyDate & Time: April 21, 2026 – 2:00 PM – 5:00 PM PT | Poster Section 16, Board #18Actimab-A AACR 2026 Presentation DetailsPoster Number: 5827Session: Radiopharmaceutical Platforms for Theranostic Precision OncologyDate & Time: April 21, 2026 – 2:00 PM – 5:00 PM PT | Poster Section 16, Board #21About Actinium Pharmaceuticals, Inc.
Actinium is a pioneer in targeted radiotherapies designed to improve outcomes for patients with cancer. The company employs a biology-driven approach to develop differentiated radiopharmaceuticals for solid tumors and hematologic malignancies. Its mission is to transform cancer treatment through innovative radioconjugates that maximize therapeutic efficacy while minimizing toxicity to healthy tissue by combining expertise in tumor biology, translational medicine, and radiochemistry. Since inception, Actinium has focused on developing innovative radiotherapies. Its pipeline reflects this strategy across three areas: (1) solid tumor therapeutics including ATNM-400 and Actimab-A with pan-tumor potential; (2) Actimab-A as a therapeutic backbone for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in collaboration with the National Cancer Institute (NCI); and (3) targeted conditioning agents including Iomab-B for bone marrow transplant and Iomab-ACT for cell and gene therapy conditioning. ATNM-400 targets a novel antigen distinct from PSMA and has demonstrated preclinical activity across metastatic castration-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), and breast cancer. Actimab-A has shown improved survival in relapsed/refractory AML with CLAG-M and is advancing toward a Phase 2/3 trial, with additional development ongoing through a CRADA with the NCI. Actinium is also advancing preclinical solid tumor programs and holds ~250 patents and patent applications, including intellectual property related to cyclotron-based production of Ac-225. For more information, please visit www.actiniumpharma.com.Forward-Looking StatementsThis press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.Investors: investorrelations@actiniumpharma.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/actinium-pharmaceuticals-announces-new-pan-tumor-preclinical-data-for-atnm-400-in-solid-tumors-and-differentiated-mechanism-for-actimab-a-in-aml-to-be-presented-at-2026-aacr-annual-meeting-302733914.htmlSOURCE Actinium Pharmaceuticals, Inc.
Original: Actinium Pharmaceuticals Announces New Pan-Tumor Preclinical Data for ATNM-400 in Solid Tumors and Differentiated Mechanism for Actimab-A in AML to be Presented at 2026 AACR Annual Meeting
US Market News
4月前
Actinium Pharmaceuticals, Inc. to Present Two Abstracts at the 2026 AACR Annual MeetingFebruary 17, 2026 7:42 AM
PR Newswire (US)
AACR Presentations to Feature ATNM-400 and Actimab-A Programs Across Solid Tumors and Hematologic Oncology ApplicationsNEW?YORK, Feb. 17, 2026 /PRNewswire/ --?Actinium Pharmaceuticals, Inc. (NYSE American:?ATNM) ("Actinium" or the "Company"), a pioneer in the development of differentiated targeted radiotherapies, today announced that it will present two abstracts at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 17–22, 2026 in San Diego, California.
Both abstracts are scheduled for presentation in the Experimental and Molecular Therapeutics category under the session titled Radiopharmaceutical Platforms for Theranostic Precision Oncology on April 21, 2026.In accordance with AACR embargo policies, details of the abstracts, including titles and full text, will become publicly available on March 17, 2026, at 4:30 PM ET via the AACR Online Program Planner.Presentation DetailsPresentation #1: Session Category: Experimental and Molecular Therapeutics
Session Title: Radiopharmaceutical Platforms for Theranostic Precision Oncology
Session Date & Time: April 21, 2026 | 2:00 PM – 5:00 PM PT
Location: Poster Section 16
Poster Board Number: 18
Poster Number: 5824Presentation #2: Session Category: Experimental and Molecular Therapeutics
Session Title: Radiopharmaceutical Platforms for Theranostic Precision Oncology
Session Date & Time: April 21, 2026 | 2:00 PM – 5:00 PM PT
Location: Poster Section 16
Poster Board Number: 21
Poster Number: 5827Actinium's Platform Strategy for Long-Term Value CreationThe AACR 2026 data will highlight Actinium's differentiated biology-driven approach to targeted radiotherapy development including:Targeting resistance-associated biology rather than tumor surface expression aloneLeveraging the high-linear energy transfer (LET) of Ac-225 to deliver potent, tumor-specific cytotoxicityBuilding a radiotherapy franchise comprised of multiple pan-tumor assetsSandesh?Seth, Chairman and CEO of Actinium Pharmaceuticals, commented, "We are pleased to have two abstracts accepted for presentation at AACR 2026. Participation in this meeting provides an important opportunity to engage with the Oncology research community. We look forward to sharing additional details once the abstracts are publicly released in accordance with AACR guidelines."About Actinium Pharmaceuticals, Inc.Actinium is a pioneer in the development of targeted radiotherapies intended to meaningfully improve patient outcomes. ATNM-400, Actinium's lead product candidate, is a novel, first-in-class, and multi-indication Actinium-225 (Ac-225) in development for prostate cancer, non-small cell lung cancer (NSCLC) and breast cancer. The antigen specifically targeted by ATNM-400 is highly expressed in metastatic castration-resistant prostate cancer (mCRPC), contributes directly to disease progression, poorer survival outcomes, and continues to be expressed at a high level even after androgen receptor inhibitor (ARPI) and Pluvicto® treatment. ATNM-400 is supported by preclinical data demonstrating tumor-specific uptake, higher efficacy than androgen receptor inhibitor enzalutamide (Xtandi®) and 177Lu-PSMA-617 radiotherapy, the active agent in Pluvicto®, durable tumor control and potent efficacy in prostate cancer models resistant to both enzalutamide and 177Lu-PSMA-617. In addition, ATNM-400 has demonstrated synergy with enzalutamide. In NSCLC, ATNM-400 showed superior efficacy to EGFR targeting therapies including osimertinib (TARGRISSO®, AstraZeneca), Dato-DXd (DATROWAY®, AstraZeneca/Daiichi Sankyo) and amivantamab (RYBREVANT®, J&J) with synergistic activity in combination with osimertinib. In breast cancer, ATNM-400 works as monotherapy in triple-negative breast cancer, hormone-positive breast cancer and also in HER2-therapy trastuzumab (HERCEPTIN® Roche) resistant breast cancer and endocrine therapy-resistant breast cancer models. The data generated to date with ATNM-400 supports its potential across treatment settings to be used either as a monotherapy, or in combination or sequenced with other therapies. Actinium's most advanced product candidate in development is Actimab-A, a CD33 targeting therapeutic, that is a potential backbone therapy for acute myeloid leukemia (AML) and other myeloid malignancies leveraging the mutation agnostic alpha-emitter radioisotope payload Actinium-225 (Ac-225). Actimab-A has demonstrated potential activity in relapsed and refractory acute myeloid leukemia (r/r AML) patients in combination with the chemotherapy CLAG-M including high rates of Complete Remissions (CR) and measurable residual disease (MRD) negativity leading to improved survival outcomes and is being advanced to a pivotal Phase 2/3 trial. In addition, Actinium is engaged with the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) for development of Actimab-A in AML and other myeloid malignancies. The first clinical trial under the CRADA will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. Additionally, Actinium is developing Actimab-A as a potential pan tumor therapy in combination with PD-1 checkpoint inhibitors including KEYTRUDA® and OPDIVO® by depleting myeloid derived suppressor cells (MDSCs), which represents a potential multi-billion-dollar addressable market. Iomab-ACT, Actinium's next generation conditioning candidate, is being developed with the goal of improving patient access and outcomes for potentially curative cell and gene therapies. Iomab-B is an induction and conditioning agent prior to bone marrow transplant in patients with r/r AML, which Actinium is seeking a potential strategic partner for the U.S. In addition, the company's R&D efforts are primarily focused on advancing several preclinical programs for solid tumor indications. Actinium holds approximately 240 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron.For more information, please visit: https://www.actiniumpharma.com/Forward-Looking StatementsThis press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.Investors:
investorrelations@actiniumpharma.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/actinium-pharmaceuticals-inc-to-present-two-abstracts-at-the-2026-aacr-annual-meeting-302689485.htmlSOURCE Actinium Pharmaceuticals, Inc.
Original: Actinium Pharmaceuticals, Inc. to Present Two Abstracts at the 2026 AACR Annual Meeting
Monroe1
2年前
Actinium Pharmaceuticals Appoints Accomplished Biopharma Industry Executive June Almenoff, M.D., Ph.D. to its Board of Directors
November 04 2024 - 7:30AM
PR Newswire (US)
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- Dr. Almenoff brings more than 25 years of drug development and leadership
experience to the Actinium Board of Directors
- Dr. Almenoff to join Actinium's Nominating and Corporate Governance Committee
NEW YORK, Nov. 4, 2024 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, today announced the appointment of June Almenoff, M.D., Ph.D. to its Board of Directors. Dr. Almenoff is an accomplished biopharma executive with over 25 years of senior leadership and drug development experience. She currently serves as a Board Director and advisor to numerous biopharma companies.
(PRNewsfoto/Actinium Pharmaceuticals, Inc.)
Andes Seth, Actinium's Chairman and CEO, stated, "Through her career, June has amassed significant experience in translational research, drug development and business development that has resulted in multiple approved products and value creation. Her experience will be invaluable to Actinium and we are delighted to add Dr. Almenoff to the Actinium Board."
Dr. Almenoff served as President and Chief Medical Officer of Furiex Pharmaceuticals, which was acquired by Actavis plc (now AbbVie) for $1.2B. Furiex developed eluxadoline (Viberzi®), which was approved both in the United States and Europe. She also served as Chief Medical Officer of RedHill Biopharma Ltd (Nasdaq: RDHL) leading a team whose work led to the recognition of Talicia® as a first-line therapy for H. pylori. Earlier in her career, Dr. Almenoff was at GlaxoSmithKline (GSK) for 12 years, where she held various positions of increasing responsibility. She was a Vice President in the Clinical Safety Organization, chaired a PhRMA-FDA working group, and worked in the area of scientific licensing. She also led the development of pioneering data analytics systems, which have been widely adopted by industry and regulators to minimize clinical risk for pharmaceutical products.
Dr. Almenoff has strong expertise in translational medicine, clinical development, commercial strategy, and business development across many therapeutic areas, and has led or contributed to numerous regulatory submissions, product approvals and launches. She is a member of the investment advisory board of the Harrington Discovery Institute, a director on the board of Avalo Therapeutics, Inc. (Nasdaq: AVTX) and Tenax Therapeutics (Nasdaq: TENX).
Dr. Almenoff added, "Targeted radiotherapy has become an important treatment option for patients in multiple oncology indications, which I believe will only continue to expand. I am impressed by Actinium's innovative R&D, clinical development experience and capabilities, as well as its proprietary Actinium-225 manufacturing technology. Collectively, Actinium has the vision and components to become a leading fully integrated specialty radiopharmaceutical company. I am excited to join the Actinium Board and look forward to working to help the company realize its vision and create value for patients and shareholders alike."
Dr. Almenoff received her B.A. cum laude from Smith College and graduated with Alpha Omega Alpha honors from the M.D.-Ph.D. program at the Icahn (Mt. Sinai) School of Medicine. She completed post-graduate medical training at Stanford University Medical Center and served on the faculty of Duke University School of Medicine. She is an adjunct professor at Duke, a Fellow of the American College of Physicians (FACP) and has authored over 70 publications.
About Actinium Pharmaceuticals, Inc.
Actinium develops Antibody Radiation Conjugates ("ARCs") and other targeted radiotherapies intended to meaningfully improve outcomes for people who have failed existing oncology therapies. Iomab-B is an induction and conditioning agent prior to bone marrow transplant in patients with relapsed and refractory acute myeloid leukemia ("r/r AML"), which Actinium is seeking a potential strategic partner for in the U.S. The company continues to advance its development for product candidate Actimab-A, a therapeutic agent that has demonstrated potential activity in r/r AML patients. In addition, Actinium is engaged with the National Cancer Institute ("NCI") under the Cooperative Research and Development Agreement ("CRADA") for development of Actimab-A in AML and other myeloid malignancies. Iomab-ACT, Actinium's next generation conditioning candidate, is being developed with the goal of improving patient access and outcomes for potentially curative cell and gene therapies. In addition, the company's R&D efforts are primarily focused on advancing several preclinical programs for solid tumor indications. Actinium holds more than 235 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron.
For more information, please visit: https://www.actiniumpharma.com/