Business
Biomea Fusion Reports Third Quarter 2021 Financial Results and Business Highlights
Announced FDA clearance of Investigational New Drug Application (IND) for BMF-219, the company’s first development candidate from the FUSION platformPhase I
About this update from Biomea Fusion, Inc.
[{"type":"text","content":"Announced FDA clearance of Investigational New Drug Application (IND) for BMF-219, the company’s first development candidate from the FUSION platformPhase I trial to enroll adult patients with relapsed or refractory acute leukemia, including those with an MLL/KMT2A gene rearrangement or NPM1 mutationScientific rationale for irreversible menin inhibition in diffuse large B cell lymphoma (DLBCL) now expected in Q4 2021Pathway validation in diabetes anticipated in Q1 2022Opened Biomea Innovation Research Center, to enable the Research & Development (R&D) team to rapidly discover and develop novel irreversible covalent small molecules by leveraging the FUSION platform to build a broad portfolio of therapeutics REDWOOD CITY, Calif., Nov. 03, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel small molecules to treat and improve the lives of patients with genetically defined cancers, reported financial results for the third quarter of 2021. “The Third Quarter was a historic one for the company as it advanced its first investigational drug into a clinical stage program. BMF-219, our internally discovered and developed small molecule, has shown broad anti-cancer activity pre-clinically and we now have the opportunity to explore this potential in patients in need.” said Thomas Butler, Biomea’s CEO and Chairman of the Board. “In September, we received FDA clearance of our IND for BMF-219, and we are now working diligently to initiate a Phase I study for the treatment of relapsed or refractory acute leukemia. We look forward to providing clinical development updates as we deepen our understanding of menin’s role in various cancers and the potential impact of irreversible inhibition for these patient populations. Our vision for this company has always been to develop a suite of novel covalent inhibitors that can act as single agent therapies or in combination, together, to build best-in-class medicine for patients. We have executed on this promise by hiring world-class drug hunters, and developers, and by custom designing and opening a state-of-the-art Research Center. We now have our first molecule ready for the clinic, and a number of exciting programs advancing through pre-clinical development.” Mr. Butler continued, “As we...