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Bayer presents first Phase 1 results from its most advanced clinical Immuno-Oncology program, aryl hydrocarbon receptor (AhR) inhibitor BAY2416964 New preclinical data on Bayer’s DGK zeta inhibitor being featured in oral presentation in New Drugs on the Horizon session New preclinical data on mutEGFR HER2 program, currently in Phase 1, will be presented Bayer progresses novel research ...
ByBayer AG
Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced the following: Phase III clinical trial, Flamingo-01, has officially started Multiple sites have begun the screening ...
Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced the following: As previously disclosed, clinical trial contracts and budgets have been executed at multiple hospitals ...
FDA review of manufacturing plans and pharmacy procedures associated with a recently placed clinical hold on the FLAMINGO-01 phase III clinical trial is underway with formal feedback from the FDA expected shortly. Greenwich is prepared to address FDA manufacturing and pharmacy procedure hold issues so that FLAMINGO-01 can commence as soon as possible. Negotiations of clinical trial contracts ...
CAMBRIDGE, Mass., May 19, 2022 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to XMT-2056, the ...
Regor Therapeutics Group announced that the investigational new drug (IND) application of RGT-419B capsule, a CDK2/4/6 small molecule inhibitor, had been approved by the National Medical Products Administration (NMPA) of China. A Phase I clinical study will be conducted in Chinese patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) ...
Regor Therapeutics Group, a clinical-stage biotech company focusing on immunology, oncology, and metabolic disorders, announced today that the first patient has been dosed in the Phase I clinical trial of the Company’s next generation targeted inhibitor RGT-419B for the treatment of breast cancer. RGT-419B is a new generation CDK2/4/6, small molecule inhibitor with an optimized kinase ...
CAMBRIDGE, Mass., March 15, 2022 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced that it will present an analysis based on the June 10th, 2021 data cut from the expansion cohort of the ...
The Phase III clinical trial, Flamingo-01, is now registered on clinicaltrials.gov with identifier NCT05232916 (view here), where more details about the trial design and a preliminary listing of the initial clinical sites can be found Company management will be attending the upcoming American Association for Cancer Research (AACR) Annual Meeting 2022, which will be held from April 8-13, 2022 ...
Collaboration focused on discovering novel ADCs for three targets by leveraging Mersana’s ADC expertise and the Dolasynthen platform with Janssen’s proprietary antibodies Mersana receives $40 million upfront payment and potentially more than $1 billion in total milestones, plus mid-single-digit to low double-digit percentage royalties on net sales CAMBRIDGE, Mass., Feb. 03, ...
The GP2 Phase III clinical trial poster was presented in person at the 2021 annual San Antonio Breast Cancer Symposium (SABCS). The Company was a SABCS sponsor and held a clinical trial planning meeting with investigators at the conference. The poster can be seen here. Critical steps toward study initiation have been completed, including manufacturing, contracting with clinical trial partners, ...
Regor Therapeutics, a clinical-stage biotech company, announced today authorization from the US Food and Drug Administration (FDA) to proceed with Regor's Phase 1 clinical development plans for RGT-419B. RGT-419B is a new generation CDK2/4/6, small molecule inhibitor with an optimized kinase activity spectrum. It is expected to improve the safety of and combat the resistance to currently ...
Dr. Daugherty has 40+ years of experience managing biotechnology projects and companies focused on cancer, immunology, vaccines, and nutraceuticals Dr. Daugherty will serve as medical monitor for the upcoming Phase III clinical trial and for potential future clinical trials, focusing on assessing any safety issues that arise on a real-time basis, leveraging his MD from the University of ...
Expanded deal focuses on Synaffix’s GlycoConnect™ site-specific ADC bioconjugation technology and adds license options for six new programs to existing deal Mersana currently developing two programs based on GlycoConnect™ site-specific ADC bioconjugation technology (XMT-1592 and XMT-1660) Synaffix B.V., a biotechnology company focused on commercializing its clinical-stage ...
Thermo Fisher Scientific and Daiichi Sankyo have expanded their partnership by signing a new agreement to co-develop a companion diagnostic (CDx) that will utilize Thermo Fisher's next-generation sequencing (NGS)-based Oncomine Dx Target Test. The CDx will be designed to identify non-small cell lung cancer (NSCLC) patients with human epidermal growth factor receptor 2 (HER2) mutations who may be ...
Seno Medical Instruments, Inc. (Seno Medical), the leader in new technology for breast cancer diagnosis using opto-acoustic (OA/US) imaging to differentiate benign from malignant masses, reported results of a study demonstrating that morphologic and functional OA/US features provide a non-invasive approach to helping distinguish breast cancer molecular subtypes. The data were presented on ...