TScan Therapeutics Inc【TCRX】株式ニュース

Cellares and TScan Therapeutics Announce Agreement to Evaluate Automated Manufacturing of TSC-101 for Patients with Hematologic MalignanciesJune 3, 2026 9:19 AM
Business Wire Collaboration will apply Cellares' fully automated Cell Shuttle® and Cell Q™ platforms to TScan’s lead TCR-T therapy candidate TSC-101 as a potentially scalable and cost-efficient path to commercialization Cellares, the first Integrated Development and Manufacturing Organization (IDMO), and TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today announced an agreement to evaluate automated clinical manufacturing of TSC-101, TScan's lead TCR-T therapy candidate for patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), through a comprehensive technical and operational assessment of Cellares' automated manufacturing and testing platforms. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260603703141/en/Cellares and TScan Therapeutics Announce Agreement to Evaluate Automated Manufacturing of TSC-101 TSC-101 is designed to treat residual disease and prevent relapse in patients with AML and MDS undergoing allogeneic hematopoietic cell transplantation (allo-HCT). The therapy candidate uses a gene modification approach to engineer T cells from a healthy donor into a patient-specific cell therapy product. As TScan advances TSC-101 towards a pivotal trial, which is expected to begin in the second quarter of 2026, the Company is evaluating Cellares’ automated manufacturing platform as a scalable and economical path to future commercial demand. Under the agreement, Cellares will automate the TSC-101 manufacturing and testing processes on the Cell Shuttle, its end-to-end manufacturing platform, and the Cell Q, its automated quality control and release testing system. These closed-system, fully automated workflows are designed to reduce process variability, minimize labor intensity, and enable consistent execution across runs and geographies, delivering the manufacturing economics and reliability that large-scale commercial production requires. “As we prepare for the initiation of our pivotal study of TSC-101 this quarter, we are increasing our efforts for commercial readiness. Establishing a scalable and cost-efficient manufacturing strategy is a critical component. Cellares’ fully automated Cell Shuttle platform represents a promising approach to automating and scaling cell therapy production, with the potential to reduce manual processes and eliminate capacity constraints,” said Ray Lockard, M.B.A., Chief Manufacturing and Quality Officer of TScan Therapeutics. “Through this evaluation, we aim to determine how this technology could strengthen our long-term manufacturing network and support broader patient access, supporting our goal of delivering transformative therapies to patients as efficiently and reliably as possible.” "Patients with AML or MDS who remain at risk of relapse following transplant represent exactly the kind of underserved population that automated manufacturing was designed to reach,” said Fabian Gerlinghaus, Co-founder and Chief Executive Officer of Cellares. "Bringing automation to a late-stage program like TSC-101, with its healthy donor-derived but patient-specific manufacturing model, is the kind of challenge the Cell Shuttle and Cell Q were built for, and we believe it represents the manufacturing economics any developer will need to reach a population of this scale." The agreement adds TCR-engineered T cell therapies to Cellares’ growing portfolio of automated cell therapy modalities, which includes CAR-T cell therapies, hematopoietic stem cell programs, and autologous progenitor T cell therapies. About TScan Therapeutics, Inc. TScan is a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer. The Company’s lead TCR-T therapy candidate is in development for the treatment of patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation (the ALLOHA™ Phase 1 heme trial). The Company is also in early stages of developing methods for in vivo engineering to treat solid tumors. In addition, the Company is applying its target discovery platform to discover novel targets in various T cell-mediated autoimmune disorders. About Cellares Cellares is the first Integrated Development and Manufacturing Organization (IDMO), providing global cell therapy development and manufacturing services through an Industry 4.0 approach to the mass manufacture of the living drugs of the 21st century. The company enables drug sponsors to develop, scale, and commercialize cell therapies with the capacity, reliability, and economics required to meet total patient demand. Cellares' fully automated platforms — Cell Shuttle? for end-to-end cell therapy manufacturing and Cell Q™ for automated in-process and release quality control — are deployed across its network of IDMO Smart Factories worldwide. These technologies deliver industry-leading manufacturing economics, higher process success rates, and the ability to produce up to 10× more cell therapy batches than conventional CDMOs with comparable footprint and headcount, resulting in the lowest cost of manufacturing in the industry. The Cell Shuttle is the first cell therapy manufacturing platform to receive the FDA's Advanced Manufacturing Technology (AMT) designation, and has demonstrated a 100% automation success rate across more than a dozen automated processes. Cellares has achieved key clinical validation milestones, including a successful IND Amendment enabling active clinical manufacturing on the Cell Shuttle platform, and the successful dosing of first patients in a partner clinical trial — marking the platform's transition from development-stage technology to clinically validated manufacturing infrastructure. These milestones span multiple therapeutic areas and cell therapy modalities, including both oncology and autoimmune indications. Headquartered in South San Francisco, California, Cellares operates its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, with additional facilities under construction in Europe and Japan. Through its global manufacturing network, Cellares is purpose-built to support both clinical and commercial programs and to expand access to life-saving cell therapies worldwide. For more information, visit www.cellares.com and follow Cellares on LinkedIn. TScan Therapeutics Forward-Looking Statements This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding the structure, timing, economics, reliability, and overall success of TScan Therapeutics, Inc.'s ("TScan") agreement with Cellares; TScan’s plans, progress, and timing related to TScan’s hematologic malignancies program, including initiation of a pivotal trial for TSC-101; TScan’s planned preclinical development and clinical trials for any of its programs; the potential benefits of any of TScan’s proprietary platforms or current or future product candidates in treating patients; and TScan’s goals and strategy. TScan intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan,” “on track,” or similar expressions or the negative of those terms. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. The express or implied forward-looking statements included in this release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: the beneficial characteristics, safety, efficacy, therapeutic effects and potential advantages of TScan’s TCR-T therapy product candidates; TScan’s expectations regarding its preclinical studies being predictive of clinical trial results; TScan’s cleared INDs being indicative or predictive of bringing TScan closer to its goal of providing customized TCR-T therapies to treat patients with cancer; the timing of the launch, initiation, progress, expected results and announcements of TScan’s preclinical studies, clinical trials and its research and development programs; TScan’s ability to enroll patients for its clinical trials within its expected timelines; TScan’s plans relating to developing and commercializing its TCR-T therapy product candidates, if approved, including sales strategy; estimates of the size of the addressable market for TScan’s TCR-T therapy product candidates; TScan’s manufacturing capabilities and the scalable nature of its manufacturing process; TScan’s estimates regarding expenses, future milestone payments and revenue, capital requirements and needs for additional financing; TScan’s expectations regarding competition; TScan’s anticipated growth strategies; TScan’s ability to attract or retain key personnel; TScan’s ability to establish and maintain development partnerships and collaborations; TScan’s expectations regarding federal, state and foreign regulatory requirements; TScan’s ability to obtain and maintain intellectual property protection for its proprietary platform technology and our product candidates; the sufficiency of TScan’s existing capital resources to fund its future operating expenses and capital expenditure requirements; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of TScan’s most recent Annual Report on Form 10-K and any other filings that TScan has made or may make with the SEC in the future. Any forward-looking statements contained in this release represent TScan’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, TScan explicitly disclaims any obligation to update any forward-looking statements. View source version on businesswire.com: https://www.businesswire.com/news/home/20260603703141/en/ Cellares Contacts
Business Development: bd@cellares.com
Investors: ir@cellares.com
Media: pr@cellares.com TScan Contacts
Investors and Media:
Caileigh Dougherty
AVP, Head of Corporate Communications & Investor Relations
857-399-9890
cdougherty@tscan.com Original: Cellares and TScan Therapeutics Announce Agreement to Evaluate Automated Manufacturing of TSC-101 for Patients with Hematologic Malignancies

Combination Therapies Reshape Oncology: A $748B Market Shifts Standard of CareMarch 19, 2026 10:00 AM
PR Newswire (US)

Issued on behalf of Oncolytics Biotech Inc.VANCOUVER, BC, March 19, 2026 /PRNewswire/ -- USANewsGroup.com News Commentary — The global oncology market is valued at $279.98 billion in 2026 and is on track to reach $748.17 billion by 2035[1], a structural realignment driven by the shift from single-agent treatments toward synergistic combination platforms and next-gen cell therapies. The immuno-oncology segment alone is projected to expand from $65.22 billion in 2025 to $170.19 billion by 2032[2], as a wave of combination therapy approvals converts tumors once resistant to immunotherapy into viable targets. Institutions are positioning for this shift through companies like Oncolytics Biotech (NASDAQ: ONCY), Gilead Sciences (NASDAQ: GILD), enGene Holdings (NASDAQ: ENGN), TScan Therapeutics (NASDAQ: TCRX), and Day One Biopharmaceuticals (NASDAQ: DAWN) (soon to be Servier), which are each advancing translational data or near-term regulatory milestones in the 2026 cycle.Goldman Sachs has projected 2026 will be a record-breaking year for biopharma dealmaking, with pharma and biotech companies remaining the primary target as a patent cliff looms which could result in the loss of hundreds of billions in revenue[3]. This structural shift creates a window for companies with asymmetric upside in high-value solid tumor markets, as the FDA's expanded accelerated approval framework—now covering gene therapies and next-generation combination regimens—compresses the timeline from translational data to commercial launch, making regulatory milestones the primary value driver for the 2026 immuno-oncology investment cycle[4]. Oncolytics Biotech (NASDAQ: ONCY) is presenting new mechanistic and translational data at the American Association for Cancer Research (AACR) Annual Meeting in San Diego this April, data that adds scientific depth to the company's push into some of cancer's hardest-to-treat corners.The two abstracts, drawn from the AWARE-1 breast cancer study and the GOBLET gastrointestinal cancer trial, both center on the same question: can pelareorep, the company's lead drug, make tumors more vulnerable to immunotherapy? The short answer, based on these findings, appears to be yes. In AWARE-1, biopsies showed pelareorep triggering the formation of tertiary lymphoid structures, essentially localized immune hubs that help the body mount a sustained attack on cancer cells.Tumors that would otherwise stay "cold" and invisible to the immune system showed signs of becoming "hot." In GOBLET Cohort 1, patients with pancreatic cancer who showed early immune activation after four weeks on a pelareorep-based regimen lived longer without their disease progressing than those who did not, 7.5 months compared to 5.6 months. That same treatment combination previously posted a 62% objective response rate in first-line pancreatic cancer patients, more than double what chemotherapy alone has historically produced.The data matter because they help explain the results Oncolytics has already reported in colorectal cancer, where the backdrop is equally encouraging. The company recently launched REO 033, a randomized Phase 2 trial testing pelareorep alongside bevacizumab and FOLFIRI in second-line RAS-mutated, microsatellite-stable metastatic colorectal cancer, a patient group with very few good treatment options today.The trial builds on earlier results from REO 022, where the same drug combination produced 27 months of overall survival, 11.2 months of progression-free survival, and a 33% objective response rate, against 16.6 months, 5.7 months, and roughly 10% for the standard of care. The FDA took notice, granting the regimen Fast Track Designation earlier this year. The second-line KRAS-mutant colorectal cancer market is estimated at $3 to $5 billion annually. REO 033 expects to open its first site next month, with preliminary data targeted for year-end 2026.Oncolytics is a clinical-stage biotechnology company that has spent years building a scientific case for pelareorep across multiple tumor types. Across anal cancer, pancreatic cancer, and now colorectal cancer, the drug is accumulating a consistent body of evidence as something that may make other gastrointestinal cancer treatments work better. That kind of backbone role, if confirmed in larger trials, could position Oncolytics as a meaningful partner in the broader immuno-oncology landscape, where combination strategies are increasingly where the field is heading.CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/In other industry developments:Gilead Sciences (NASDAQ: GILD) reported fourth quarter and full year 2025 financial results showing oncology revenues of $3.2 billion for the year, anchored by a 6% increase in Trodelvy sales to $1.4 billion on higher breast cancer demand, while Yescarta received a label update removing a limitation around Primary Central Nervous System Lymphoma, making it the only CAR-T therapy in relapsed or refractory large B-cell lymphoma to have that restriction lifted. The company also presented positive pivotal Phase 2 iMMagine-1 data for its Arcellx-partnered CAR T-cell therapy anitocabtagene autoleucel in 4L+ relapsed or refractory multiple myeloma at the 2025 American Society of Hematology meeting, with two additional cancer therapy launches anticipated in 2026."In 2026, our potential new launches include two cancer therapies and an additional HIV treatment option, and we look forward to building on the launches of Yeztugo and Livdelzi for liver disease," said Daniel O'Day, Chairman and CEO of Gilead Sciences.Gilead Sciences closed 2025 with $10.6 billion in cash and marketable debt securities and generated $10.0 billion in operating cash flow for the full year. For 2026, Gilead Sciences guides for total product sales of $29.6 billion to $30.0 billion and non-GAAP diluted EPS of $8.45 to $8.85, with anticipated oncology launches expected to contribute meaningfully to growth alongside continued HIV franchise momentum.enGene Holdings (NASDAQ: ENGN) reported Q1 2026 financial results reflecting continued advancement of its lead non-viral gene therapy candidate, detalimogene voraplasmid, toward a Biologics License Application submission targeted for the second half of 2026. The company's pivotal LEGEND cohort of 125 BCG-unresponsive NMIBC patients demonstrated a 63% complete response rate at any time and a 62% CR rate at 6 months, while enGene Holdings closed Q1 with $312.5 million in cash and marketable securities."As data from LEGEND's pivotal cohort in high-risk, BCG-unresponsive NMIBC continues to mature, we look forward to providing an update at a spring medical conference," said Ron Cooper, President and CEO of enGene Holdings. "With RMAT and CDRP designations for detalimogene, we are in active dialogue with the FDA to ensure regulatory and manufacturing readiness as we plan for a BLA submission in the second half of this year and potential launch in 2027."enGene Holdings expanded its Hercules Capital debt facility to $125 million in January 2026, providing additional non-dilutive capital ahead of its planned commercial launch. The company expects its current cash position to fund operations into the second half of 2028, and 12-month complete response data from the LEGEND pivotal cohort is expected in 2H 2026.TScan Therapeutics (NASDAQ: TCRX) reported Q4 and full year 2025 financial results while providing updates on its TCR-engineered T cell hematologic malignancies program, including the completion of enrollment in Cohort C of the Phase 1 ALLOHA trial and FDA clearance of INDs for two new CD45-targeting candidates, TSC-102-A01 and TSC-102-A03. Full year 2025 collaboration and license revenue reached $10.3 million versus $2.8 million in 2024, with cash and equivalents of $152.4 million expected to fund operations into 2H 2027."The regulatory and operational progress we have made over the last several months related to our heme program is exciting," said Gavin MacBeath, Ph.D., CEO of TScan Therapeutics. "We expect the momentum to continue into the second quarter when we plan to share the initial data from patients enrolled into Cohort C in the ALLOHA study as well as initiate TScan's first Phase 3 trial. The data we presented at ASH in December 2025 continue to support our decision to focus the Company's efforts on development of therapeutics for patients with heme malignancies. Additionally, the recent FDA clearance of INDs for TSC-102-A01 and TSC-102-A03 will allow us to bring our TCR-T therapies to twice as many patients who currently have limited options in the post-transplant setting."TScan Therapeutics discontinued its PLEXI-T solid tumor trial in November 2025 to concentrate resources on hematologic malignancies, and anticipates sharing preclinical proof-of-concept data from its autoimmunity program in 2H 2026. Updated Cohort C data and initiation of a Phase 1 study for TSC-102-A01 and TSC-102-A03 are both expected in the second half of 2026.Day One Biopharmaceuticals (NASDAQ: DAWN) announced a definitive acquisition agreement under which Servier will acquire all outstanding shares of Day One Biopharmaceuticals for $21.50 per share in cash, representing a total equity value of approximately $2.5 billion. The offer price represents a premium of approximately 68% over Day One Biopharmaceuticals' closing price on March 5, 2026, and approximately 86% over its one-month volume weighted average price, reflecting significant value recognition for the company's lead pediatric low-grade glioma program and broader oncology pipeline."Servier's successful track record in rare cancers and its commitment to advancing targeted therapies makes it the ideal home for our portfolio as part of Day One Biopharmaceuticals' mission to bring medicines to patients of all ages with life threatening diseases," said Jeremy Bender, Ph.D., CEO of Day One Biopharmaceuticals. "Joining Servier represents a unique opportunity to extend the reach of our science and our lead program in pediatric low-grade glioma."The transaction is subject to customary closing conditions, including shareholder tender and U.S. antitrust clearance, and is expected to close in Q2 2026. Day One Biopharmaceuticals' Board of Directors has unanimously recommended that shareholders tender their shares, and Servier expects to fund the acquisition through existing cash and investments.Article Source: usanewsgroup.comCONTACT:USA NEWS GROUP
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Original: Combination Therapies Reshape Oncology: A $748B Market Shifts Standard of Care