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Yahoo
8 hours ago
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Immatics IMA203 PRAME Cell Therapy Data Presented at 2025 ASCO Annual Meeting Continues to Show Strong Anti-tumor Activity and Durability in Patients with Metastatic Melanoma
Extended Phase 1b trial follow-up on IMA203 PRAME cell therapy in 33 heavily pretreated patients with metastatic melanoma demonstrates favorable tolerability and promising clinical activity with ongoing deep and durable objective responses up to >2.5 years IMA203 PRAME cell therapy one-time infusion in all melanoma patients shows cORR of 56%; mDOR of 12.1 months at mFU of 13.4 months; mPFS of 6.1 months; mOS of 15.9 months Cutaneous melanoma subgroup post-checkpoint inhibitor shows cORR of 50%, mDOR not reached at mFU of 16.7 months; mPFS of 6.0 months Uveal melanoma subgroup, including tebentafusp-refractory patients shows cORR of 67%, mDOR of 11.0 months at mFU of 13.4 months; mPFS of 8.5 months Positive Phase 1b data and high PRAME prevalence in melanoma reinforce the basis for the ongoing SUPRAME Phase 3 trial in previously treated advanced or metastatic cutaneous melanoma, as well as the continued Phase 1b expansion in uveal melanoma ASCO presentations further substantiate Immatics' global leadership in precision targeting of PRAME and potential of IMA203 to be the Company's first PRAME product Stafford, Texas and Tuebingen, Germany, May 31, 2025 – Immatics N.V. (NASDAQ: IMTX, 'Immatics' or the 'Company'), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced the presentation of expanded data from the ongoing Phase 1b clinical trial evaluating IMA203 PRAME cell therapy in heavily pretreated patients with metastatic melanoma. The longer follow-up of patients demonstrates a consistent and favorable tolerability profile as well as durable responses with a confirmed ORR of 56%. In addition, the Company provided details from a Trial in Progress poster on SUPRAME, the ongoing Phase 3 clinical trial evaluating IMA203 in patients with unresectable or metastatic cutaneous melanoma who have received prior treatment with a checkpoint inhibitor. The data from the ongoing Phase 1b trial will be presented on Saturday, May 31, 2025, during an oral presentation by Martin Wermke, M.D. The Trial in Progress poster (TiP) will be presented at the conference on Monday, June 2, 2025, by Jason Luke, M.D., FACP, FASCO. The IMA203 slides, including the ASCO data and additional data, are accessible in the 'Events & Presentations' section of the Investor & Media section of the Company's website. 'Patients with advanced melanoma post-failure of checkpoint inhibition are left to face frequent and often rapid disease progression and limited long-term survival. These individuals are in urgent need of new treatments that deliver deeper and more durable responses,' said Cedrik Britten, M.D., Chief Medical Officer at Immatics. 'We believe the data presented today emphasize the strength, durability and tangible therapeutic potential of our one-time infusion PRAME cell therapy, IMA203, in this patient population. These positive results reinforce our commitment to actively advance IMA203 through the ongoing Phase 3 SUPRAME trial to bring this PRAME therapy to the market as soon as possible.' 'PRAME is a highly prevalent target that is expressed in more than 50 cancers. This, combined with the data presented at ASCO, further strengthens our position as the global leader in precision targeting of PRAME. We view our progress in melanoma as a critical step in our journey to building the broadest PRAME franchise with the most indications and modalities and delivering novel PRAME immunotherapies to cancer patients with high unmet medical needs,' said Harpreet Singh, Ph.D., Chief Executive Officer and Co-Founder at Immatics. Oral Presentation Summary - IMA203 Phase 1b Trial Patient Population: Heavily pretreated patients with metastatic melanoma As of April 7, 2025, 33 heavily pretreated patients with metastatic melanoma were administered a one-time infusion of IMA203 at the recommended Phase 2 dose (RP2D, 1 to 10 billion total TCR T cells) in the Phase 1b dose expansion. The treated patient population consisted of cutaneous melanoma (n=14), uveal melanoma (n=16), mucosal melanoma (n=2) and melanoma of unknown primary (n=1). Patients had a median of 2 lines of prior systemic treatments. The subgroup of patients with cutaneous melanoma had a median of 2.5 lines of prior systemic treatments, thereof a median of 2 lines of prior immune checkpoint inhibitors. Safety: Favorable tolerability The safety population included 74 patients combined from the Phase 1a dose escalation and Phase 1b dose expansion across all dose levels and all tumor types. IMA203 has maintained a favorable tolerability profile. The most frequent treatment-emergent adverse events were anticipated cytopenias associated with lymphodepletion. Expected and manageable cytokine release syndrome (CRS) was mostly Grades 1 and 2, which is consistent with the mechanism of action (Grade 1: 37%, Grade 2: 47%, Grade 3: 11%, Grade 4: 0%). No patients experienced long-term CRS. Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred infrequently, was manageable and mostly mild (Grade 1: 5%, Grade 2: 4%, Grade 3: 4%, Grade 4: 0%). No IMA203-related Grade 5 events were observed. Tolerability in the Phase 1b melanoma subset was generally consistent with the full IMA203 tolerability profile. Anti-tumor activity and durability: Encouraging anti-tumor activity of IMA203 PRAME cell therapy, including durable responses up to >2.5 years with longer follow-upAll melanoma1,2 (n=33) Cutaneous melanoma (n=14) Uveal melanoma2 (n=16) cORR 56% (18/32) 50% (7/14) 67% (10/15) ORR 64% (21/33) 57% (8/14) 69% (11/16) DCR 91% (30/33) 93% (13/14) 88% (14/16) mDOR (range) / mFU [mo] 12.1 (1.8+, 32.6+) / 13.4 NR3 (4.2, 32.6+) / 16.7 11.0 (1.8+, 31.6) / 13.4 mPFS (range) / mFU [mo] 6.1 (1.4, 34.0+) / 14.4 6.0 (1.4, 34.0+) / 14.4 8.5 (1.4, 32.9) / 8.7 mOS (range) / mFU [mo] 15.9 (2.4, 34.2+) / 14.4 13.9 (2.4, 34.0+) / 14.4 16.2 (3.2+, 34.2+) / 14.5 The PFS rate was 53% at six months and 27% at 12 months. The overall survival rate was 61% at 12 months. In addition, 42% (14/33) of patients had a deep response (≥50% tumor reduction) with a mPFS of 12.9 months. Translational analyses demonstrated that treatment with IMA203 resulted in the shrinkage of metastatic target lesions throughout the body. This included reductions in difficult-to-treat metastases, such as liver, lung, lymph node, abdomen/peritoneum, skin and others. Some individual lesions had a complete resolution (-100%). All patients (n=3) who had a best overall response of progressive disease according to RECIST 1.1 experienced shrinkage of individual lesions. The positive Phase 1b data and high PRAME prevalence (~90-95% in melanoma) reinforce the potential of IMA203, which is currently being evaluated in the ongoing SUPRAME Phase 3 trial in previously treated advanced or metastatic cutaneous melanoma, as well as the continued Phase 1b expansion into uveal melanoma. Trial-in-Progress Poster Summary – IMA203 SUPRAME Phase 3 Trial Based on the positive clinical data and supported by the FDA RMAT designation4, Immatics advanced its PRAME cell therapy, IMA203, into the randomized-controlled Phase 3 SUPRAME trial (NCT06743126). SUPRAME is a prospective, multicenter, open-label, randomized, actively controlled Phase 3 clinical trial evaluating the efficacy, safety and tolerability of IMA203 vs. investigator's choice in ~360 patients with unresectable or metastatic cutaneous melanoma who have received prior treatment with a checkpoint inhibitor. Patient eligibility is determined by protocol inclusion/exclusion criteria, including HLA screening. If patients are HLA-A*02:01 positive and meet the eligibility criteria, they will undergo leukapheresis and be randomized 1:1. Patients in the IMA203 arm will undergo lymphodepletion with cyclophosphamide (500 mg/m2 x 4 days) and fludarabine (30 mg/m2 x 4 days), subsequent infusion of 1-10 x109 IMA203 PRAME-directed TCR T cells, followed by low-dose IL-25 (subcutaneous). Patients in the control arm will receive either nivolumab/relatlimab, nivolumab, ipilimumab, pembrolizumab, lifileucel (in the US), or chemotherapy based on investigator's choice. The primary endpoint is blinded independent central review ('BICR')-assessed (RECIST 1.1) PFS. Secondary endpoints include OS, ORR, safety and patient-reported outcomes about quality of life. The expected median PFS in this post-checkpoint inhibitor patient population6 is 2-3 months, and the IMA203 Phase 1b data presented today at ASCO indicate a continued median PFS of ≥6 months. SUPRAME is planned to be conducted in more than 50 sites in North America and Europe. Patient enrollment and randomization for the trial was initiated in early 2025 and is expected to be completed in 2026. A pre-specified interim data analysis will be triggered upon the occurrence of a defined number of events for PFS (progressive disease or death)7, anticipated to occur after approximately 200 patients. Immatics aims to submit a Biologics License Application (BLA) to the FDA in 1Q 2027 for full approval. About PRAMEPRAME is a target expressed in more than 50 cancers. Immatics is the global leader in precision targeting of PRAME and has the broadest PRAME franchise with the most PRAME indications and modalities. The Immatics PRAME franchise currently includes three product candidates, two therapeutic modalities and a combination therapy that target PRAME: IMA203 PRAME cell therapy, IMA203CD8 PRAME cell therapy (GEN2), IMA402 PRAME bispecific, IMA203 in combination with Moderna's PRAME adaptive immune modulating therapy. About IMA203 PRAME Cell TherapyIMA203 is a PRAME-directed TCR T-cell therapy engineered to recognize an intracellular PRAME-derived peptide presented by HLA-A*02:01 on the cell surface and initiate a potent and specific anti-tumor response. IMA203 PRAME cell therapy is currently being evaluated in a registration-enabling randomized controlled Phase 3 trial, 'SUPRAME,' in patients with unresectable or metastatic cutaneous melanoma who have disease progression on or after treatment with at least one checkpoint inhibitor. In parallel, the Phase 1b clinical trial in patients with PRAME cancers is ongoing with a focus on uveal melanoma. About ImmaticsImmatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer. Immatics intends to use its website as a means of disclosing material non-public information. For regular updates you can also follow us on LinkedIn and Instagram. Forward-Looking StatementsCertain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or the Company's future financial or operating performance. For example, statements concerning timing of data read-outs for product candidates, the timing, outcome and design of clinical trials, the nature of clinical trials (including whether such clinical trials will be registration-enabling), the timing of IND, CTA or BLA filings, estimated market opportunities of product candidates, the Company's focus on partnerships to advance its strategy, and other metrics are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as 'may', 'should', 'expect', 'plan', 'target', 'intend', 'will', 'estimate', 'anticipate', 'believe', 'predict', 'potential' or 'continue', or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management's control including general economic conditions and other risks, uncertainties and factors set forth in the Company's Annual Report on Form 20-F and other filings with the Securities and Exchange Commission (SEC). Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification. For more information, please contact: MediaReal ChemistryMatt Wrightmwright@ Immatics SilversteinHead of StrategyPhone: +1 346 319-3325InvestorRelations@ - END - 1 Melanoma efficacy population includes n=3 patients with other melanoma subtypes (n=2 mucosal melanoma, n=1 melanoma of unknown primary; data can be found in the IMA203 slides). 2 cORR excludes 1 uveal melanoma patient with ongoing unconfirmed PR.3 NR, not reachedPD: progressive disease; BL: baseline; PR: partial response; (c)ORR: (confirmed) objective response rate; DCR: disease control rate at week 6; mDOR: median duration of response; mFU: median follow-up; mPFS: median progression-free survival; mOS: median overall survival4Includes all benefits of Breakthrough Therapy Designation.5 1m IU daily days 1-5 and twice daily days 6-10, total dose is approx. only 5% of the overall dose for high-dose IL-2 given typically with TIL therapy (Sarnaik et al. 2021 Journal of Clinical Oncology).6 Ascierto et al., 2023, Diab et al., 2024.7 Centrally assessed by BICR using RECIST v1.1. 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Yahoo
11 hours ago
- Business
- Yahoo
Stevanato Group S.p.A. (STVN): A Bull Case Theory
We came across a bullish thesis on Stevanato Group S.p.A. (STVN) on Best Anchor Stocks' Substack. In this article, we will summarize the bulls' thesis on STVN. Stevanato Group S.p.A. (STVN)'s share was trading at $22.61 as of 22nd May. STVN's trailing and forward P/E were 43.55 and 37.45 respectively according to Yahoo Finance. A biopharmaceutical facility with technicians working on a manufacturing line of treatments and preventions. Stevanato's recent earnings release highlighted a sharp return to growth, with Q1 revenue up 9% to €256.6 million—far ahead of expectations—driven primarily by strong performance in its high-value products (HVPs) and the ramp-up of new facilities in Latina and Fishers. Despite this impressive beat, the stock gave up early gains, staying true to its volatile trading pattern. However, the real story lies in Stevanato's compelling margin expansion potential and what appears to be sandbagged guidance. Margins improved meaningfully in Q1, yet remain artificially depressed due to underutilized vial capacity, dilutive effects from new plant ramp-ups, and a still-recovering engineering division. Net income grew 41% on just 9% revenue growth, illustrating the leverage embedded in the model. Management's commentary suggests that over time, as engineering margins normalize and the HVP mix continues to increase—especially with major projects like Ez-Fill cartridges for likely customers such as Novo Nordisk—the company could unlock over 1,000 basis points in margin expansion. Furthermore, current HVP gross margins are estimated to be double those of bulk products, signaling substantial upside. While guidance for 2025 was only modestly raised and Adjusted EBITDA lowered slightly due to tariffs, this conservatism appears more like strategic sandbagging than a real slowdown. Based on Q1 results and seasonal trends, full-year revenue could exceed management's guidance by 2.5%, implying double-digit growth is very much in reach. With expanding margins, a durable growth runway driven by mix shift and replacement demand, and strategic positioning in the U.S., Stevanato offers a long-term upside narrative not reflected in current valuation multiples. Stevanato Group S.p.A. (STVN) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 11 hedge fund portfolios held STVN at the end of the fourth quarter which was 11 in the previous quarter. While we acknowledge the risk and potential of STVN as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is more promising than STVN but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey.
Yahoo
12 hours ago
- Business
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Gyre Therapeutics, Inc. (GYRE) Raises $23M in Public Stock Offering to Fund Liver Fibrosis Trials
Gyre Therapeutics, Inc. (NASDAQ:GYRE), a biopharmaceutical company developing innovative fibrosis-focused therapies, has successfully closed a public offering, raising approximately $23 million in gross proceeds. The offering included 2,555,555 shares of common stock at $9.00 per share, with Jefferies serving as lead book-running manager and H.C. Wainwright & Co. as co-manager. A research scientist in an idiopathic pulmonary fibrosis laboratory, carrying out clinical trials. The capital infusion, which follows the full exercise of underwriters' options, will support Gyre Therapeutics, Inc. (NASDAQ:GYRE)'s ongoing Phase 2 clinical trial of F351, a promising treatment targeting liver fibrosis in patients with metabolic dysfunction-associated steatohepatitis (MASH) in the United States. The funds will also bolster research and development, manufacturing scale-up, and general corporate operations. The shares were offered under a shelf registration statement previously approved by the SEC. Gyre Therapeutics, Inc. (NASDAQ:GYRE)'s latest fundraising effort underscores its commitment to advancing therapies for chronic diseases marked by fibrosis, aiming to address significant unmet medical needs. While we acknowledge the potential of GYRE to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than GYRE and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Sign in to access your portfolio
Globe and Mail
a day ago
- Business
- Globe and Mail
Fate Therapeutics Appoints Matthew Abernethy, M.B.A., to its Board of Directors
SAN DIEGO, May 30, 2025 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients, today announced the appointment of Matthew Abernethy, M.B.A., to its Board of Directors effective as of May 29, 2025. Mr. Abernethy brings to the Company over 15 years' experience in corporate finance and investor relations in the biotech and medical device industry. In addition, the Company announced that Timothy P. Coughlin stepped down from the Board of Directors, effective concurrently with Mr. Abernethy's appointment. 'Mr. Abernethy is a highly accomplished financial and business leader in the biopharmaceutical industry, and we are delighted to welcome him to our Board of Directors,' said Bob Valamehr, Ph.D., M.B.A., President and Chief Executive Officer of Fate Therapeutics. 'Matt's leadership in building a high-growth commercial biotech company and insights in capital strategy and long-term planning through key inflection points, will be invaluable as we continue to advance our pipeline of innovative cell therapy products in autoimmunity and oncology for broad patient access. I also would like to extend my deep gratitude to Tim for his many valuable contributions and years of service to Fate.' 'I feel privileged to be joining the Board of Directors of Fate Therapeutics at this transformative time when cell therapy has the potential to help many patients across both cancer and immunological disorders,' said Mr. Abernethy. 'Specifically, FT819 provides a highly differentiated, true off-the-shelf approach, with the potential to provide long term remission for patients with lupus and other autoimmune diseases. I look forward to joining Fate's Board of Directors with the aim to help many patients' lives over the years ahead.' Mr. Abernethy is a leading financial executive with extensive experience in biopharma and medical devices. Since November 2017, Mr. Abernethy has served as Chief Financial Officer of Neurocrine Biosciences, Inc. (Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, overseeing finance, accounting, information technology, and a variety of other functions. Prior to Neurocrine Biosciences, Inc., he held a variety of finance roles at Zimmer Biomet Holdings, Inc., a global medical technology leader, from February 2009 to November 2017. Mr. Abernethy began his career with KPMG LLP and became a certified public accountant (currently inactive). Mr. Abernethy holds a B.S. in Accounting and Business Administration from Grace College and an M.B.A. from the University of Chicago. About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company's pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit Forward-Looking Statements This release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the advancement of, plans related to, and the therapeutic potential of the Company's product candidates, the Company's clinical development and manufacturing strategies, and the Company's plans for the clinical investigation and manufacture of its product candidates. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company's research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company's product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company's product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company's product candidates are being developed, the amount and type of data to be generated, or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company's ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company's product candidates for clinical testing, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company's periodic filings with the Securities and Exchange Commission, including but not limited to the Company's most recently filed periodic report, and from time to time in the Company's press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.
Yahoo
2 days ago
- Business
- Yahoo
Maze Therapeutics to Participate in the Jefferies 2025 Global Healthcare Conference
SOUTH SAN FRANCISCO, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with renal, metabolic and cardiovascular diseases, today announced that Jason Coloma, Ph.D., chief executive officer of Maze Therapeutics, will present a company overview at the Jefferies 2025 Global Healthcare Conference on Thursday, June 5, 2025 at 2 p.m. ET. A live webcast will be available in the Investors section of the company's website at and archived for 60 days following the presentation. About Maze TherapeuticsMaze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which provides insights into the genetic variants in disease and links them with the biological pathways that drive disease in specific patient groups. The company's pipeline is led by two wholly owned programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for patients. For more information, please visit or follow the company on LinkedIn and X. IR/Corporate Contact:Amy Bachrodt, Maze Therapeuticsabachrodt@ Media Contact:Dan Budwick, 1ABdan@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
