KEYTRUDA® (pembrolizumab)
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Recursion Announces Vicki Goodman, M.D., as Incoming Chief Medical Officer
Globenewswire· 2026-03-25 11:59
Core Insights - Recursion has appointed Dr. Vicki Goodman as the new Chief Medical Officer, effective April 6, 2026, succeeding Dr. David Mauro [1][6] - Dr. Goodman brings over two decades of experience in oncology drug development and has held senior leadership roles in both biotech and large pharmaceutical companies [2][4][5] - The company is focused on advancing its clinical pipeline and achieving key clinical and regulatory milestones, leveraging Dr. Goodman's expertise to enhance its development programs [2][3] Company Overview - Recursion is a clinical-stage TechBio company that aims to decode biology to significantly improve lives, with a focus on developing investigational medicines across various therapeutic areas including oncology, rare diseases, neuroscience, and immunology [8] - The company utilizes an AI-native, end-to-end drug discovery and development platform known as Recursion OS, which integrates biology, chemistry, and clinical development into a unified intelligence system [8] - Recursion's infrastructure includes automated biology and chemistry laboratories in Salt Lake City, Utah, and Milton Park, Oxfordshire, designed to generate proprietary data at an industrial scale [9] Leadership Transition - Dr. David Mauro, the outgoing CMO, has contributed significantly to strengthening Recursion's medical organization and advancing its clinical portfolio over the past three years [6][7] - The leadership transition is seen as a strategic move to enhance the company's capabilities in navigating critical regulatory and clinical development stages [3][7]
Pyxis Oncology Provides Business Update and Reports Fourth Quarter and Full Year 2025 Financial Results
Globenewswire· 2026-03-23 11:00
Core Insights - Pyxis Oncology has completed target enrollment in the Phase 1 monotherapy dose expansion study of micvotabart pelidotin (MICVO) for 2L+ recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in Q1 2026, with updated data expected mid-2026 [1][5] - The company has appointed Thomas Civik as Interim Chief Executive Officer, focusing on clinical execution and operations to deliver robust datasets [3][6] - Financial results for the year ended December 31, 2025, show revenues of $13.9 million, a decrease from $16.1 million in 2024, with a net loss of $79.6 million [8][10] Clinical Development Updates - The Phase 1 monotherapy study of MICVO in 2L+ R/M HNSCC reported a 46% confirmed objective response rate (ORR) and a 92% disease control rate (DCR) [4] - In combination with KEYTRUDA, MICVO showed a 71% confirmed ORR and a 100% DCR in 1L/2L+ R/M HNSCC [4] - The ongoing studies are designed to evaluate the impact of modified weight-based dosing on safety and efficacy, with results anticipated in mid-2026 [7][11] Financial Performance - Total revenues for 2025 were $13.9 million, down from $16.1 million in 2024, primarily due to changes in milestone revenues and royalty rights [10][15] - Research and development expenses increased to $73.7 million in 2025 from $58.7 million in 2024, attributed to higher clinical trial costs [10][16] - The company reported a net loss of $79.6 million for 2025, slightly higher than the $77.3 million loss in 2024 [10][16] Leadership and Corporate Updates - Thomas Civik was appointed as Interim CEO in February 2026, bringing extensive experience in advancing cancer therapeutics [6][10] - Heather Knowles joined as Senior Vice President, Head of Global Clinical Operations, enhancing the company's clinical development capabilities [10] - The company has also appointed Alex Kane as Senior Vice President, Investor Relations and Capital Markets, to strengthen investor engagement [10] Pipeline and Future Outlook - Pyxis Oncology expects to report updated data from the ongoing MICVO Phase 1/2 combination study with KEYTRUDA in the second half of 2026 [7][11] - The company has received Fast Track Designation from the FDA for MICVO in treating adult patients with R/M HNSCC [12]
Evaxion to present new data at AACR Annual Meeting
Globenewswire· 2026-03-17 20:30
Core Insights - Evaxion A/S, a clinical-stage TechBio company, is set to present two abstracts at the AACR Annual Meeting in April 2026, focusing on its AI-Immunology™ platform and personalized cancer vaccines [1][6]. Group 1: Abstract Presentations - The first abstract will present new biomarker and immunogenicity data for the personalized cancer vaccine EVX-01, which is currently being evaluated for advanced melanoma treatment [2][3]. - The second abstract will discuss the identification of endogenous retrovirus-derived neoantigens for personalized vaccines targeting glioblastoma, a type of brain cancer with limited treatment options [4][6]. Group 2: Clinical Trials and Collaborations - The data for EVX-01 comes from a phase 2 trial that combines the vaccine with MSD's KEYTRUDA® therapy in patients with advanced melanoma, where each vaccine is tailored to the individual patient's biology [3]. - Evaxion will also engage in the AACR Oncology Industry Partnering event to explore potential business partnerships and scientific collaborations [4][6]. Group 3: Company Overview - Evaxion utilizes its proprietary AI-Immunology™ platform to develop novel vaccine candidates for cancer and infectious diseases, emphasizing rapid and efficient target discovery and drug design [7]. - The company has a clinical pipeline that includes both personalized and off-the-shelf cancer vaccine candidates, addressing significant unmet medical needs [7].
KEYTRUDA® (pembrolizumab) Plus Paclitaxel With or Without Bevacizumab Significantly Improved Key Secondary Endpoint of Overall Survival (OS) Versus Paclitaxel With or Without Bevacizumab in Patients With Platinum-Resistant Recurrent Ovarian Cancer
Businesswire· 2026-02-27 15:15
Core Insights - Merck announced results from the final analysis of the pivotal Phase 3 KEYNOTE-B96 trial, demonstrating that KEYTRUDA® (pembrolizumab) in combination with chemotherapy significantly improved overall survival for patients with platinum-resistant recurrent ovarian cancer [1] Group 1: Trial Results - The KEYNOTE-B96 trial, also known as ENGOT-ov65, showed significant improvement in overall survival (OS) as a key secondary endpoint [1]
KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) Reduced Risk of Event-Free Survival Events by 47% and Risk of Death by 35% for Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer When Given Before and After Surgery
Businesswire· 2026-02-27 15:00
Core Insights - Merck announced that the combination of KEYTRUDA® (pembrolizumab) and Padcev® (enfortumab vedotin-ejfv) significantly improved patient outcomes in muscle-invasive bladder cancer (MIBC) [1] Efficacy Results - The combination therapy reduced the risk of event-free survival (EFS) events by 47% compared to neoadjuvant chemotherapy and surgery [1] - Additionally, it reduced the risk of death by 35% when administered before and after surgery in patients eligible for cisplatin-based chemotherapy [1]
Merck and Mayo Clinic Announce New Research and Development Collaboration to Support AI-Enabled Drug Discovery and Precision Medicine
Businesswire· 2026-02-18 11:45
Core Insights - Merck and Mayo Clinic have announced a strategic collaboration to leverage AI and advanced analytics for drug discovery and precision medicine, integrating Mayo Clinic's clinical insights and genomic data with Merck's AI capabilities [1] Collaboration Details - The partnership will utilize Mayo Clinic's Platform architecture and multimodal clinical data to enhance disease understanding and improve target identification for drug development [1] - This collaboration marks Mayo Clinic's first strategic partnership of this scale with a global biopharmaceutical company [1] Focus Areas - The initial focus will be on three therapeutic areas: - Neurology: Multiple sclerosis - Dermatology: Atopic dermatitis - Gastroenterology: Inflammatory bowel disease (IBD) [1] Technology Integration - Merck will access Mayo Clinic's de-identified clinical data, including laboratory results, medical imaging, clinical notes, and molecular data, to validate AI models and translate research insights into actionable strategies [1] - The collaboration aims to speed up the development of innovative therapies by combining clinical expertise with advanced AI tools [1] Company Background - Merck, known as MSD outside the U.S. and Canada, has a long history of developing important medicines and vaccines, aspiring to be a premier research-intensive biopharmaceutical company [1] - Mayo Clinic is a nonprofit organization focused on innovation in clinical practice, education, and research, committed to providing compassionate care [1]
KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Plus Paclitaxel ± Bevacizumab, Approved for Certain Adults with PD-L1+ (CPS ≥1) Platinum-Resistant Ovarian Carcinoma as Second or Third Line Treatment
Businesswire· 2026-02-11 11:45
Core Viewpoint - Merck has received FDA approval for KEYTRUDA® and KEYTRUDA QLEX™ for treating adults with PD-L1+ platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer [1] Group 1: Product Approval - The FDA approved KEYTRUDA® (pembrolizumab) for the treatment of adults with PD-L1+ (Combined Positive Score [CPS] 1) [1] - KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) plus paclitaxel, with or without bevacizumab, is also approved for the same indication [1]
Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC)
Businesswire· 2026-02-11 11:45
Core Viewpoint - Agilent Technologies Inc. has received FDA approval for PD-L1 IHC 22C3 pharmDx as the only FDA-approved companion diagnostic for identifying first-line patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 and may be eligible for treatment with KEYTRUDA® [1] Group 1 - The FDA has approved PD-L1 IHC 22C3 pharmDx as a companion diagnostic [1] - This diagnostic is specifically indicated for patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma [1] - The approval aids in identifying patients whose tumors express PD-L1 and who may be eligible for KEYTRUDA® treatment [1]
KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) Significantly Improved Event-Free Survival, Overall Survival and Pathologic Complete Response Rates for Cisplatin-Eligible Patients with MIBC When Given Before and After Surgery
Businesswire· 2025-12-17 11:45
Core Insights - Merck announced positive topline results from the Phase 3 KEYNOTE-B15 trial for patients with muscle-invasive bladder cancer (MIBC) eligible for cisplatin-based chemotherapy [1] - The trial evaluated the combination of KEYTRUDA® (pembrolizumab) and Padcev® (enfortumab vedotin-ejfv) as neoadjuvant and adjuvant treatment, showing statistically significant results [1] Company Summary - Merck, known as MSD outside the United States and Canada, is focusing on innovative cancer treatments [1] - The positive results from the KEYNOTE-B15 trial may enhance Merck's position in the oncology market [1] Industry Summary - The trial results contribute to the growing body of evidence supporting immunotherapy and targeted therapy combinations in treating bladder cancer [1] - The findings may influence treatment protocols and patient outcomes in the field of oncology [1]
Adagene Announces FDA Fast Track Designation for Muzastotug (ADG126)
Globenewswire· 2025-12-16 12:00
Core Insights - The FDA has granted Fast Track Designation to Adagene's muzastotug in combination with Merck's KEYTRUDA® for treating adult patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) without active liver metastases, highlighting the potential of this therapy to meet an unmet medical need [1][2][3] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence to create innovative therapies [4][7] - The company employs its proprietary SAFEbody technology to enhance the safety and efficacy of antibody therapies by targeting the tumor microenvironment while minimizing systemic toxicity [6][7] Clinical Development - Muzastotug is a next-generation masked anti-CTLA-4 SAFEbody designed to overcome Treg resistance in tumors, showing promising efficacy and safety in heavily pretreated patient populations [2][3] - The ongoing Phase 2 trial will evaluate muzastotug in combination with pembrolizumab, with a focus on late-line patients with MSS CRC without liver metastases [5][7] - The primary endpoint for the Phase 2 trial is overall response rate (ORR), while the Phase 3 trial will focus on overall survival (OS) as the primary endpoint [5] Future Plans - Adagene plans to share updated topline Phase 1b/2 clinical data in the coming months and is preparing for a registration trial set to begin in 2027 [3][5]