Biomea Fusion, Inc. - BMEA STOCK NEWS

Biomea Fusion, Inc. (BMEA) has initiated the Phase II trial of COVALENT-111, evaluating BMF-219, a covalent menin inhibitor aimed at type 2 diabetes treatment. Following FDA IND clearance, the trial is now enrolling patients in a randomized, placebo-controlled study. BMF-219 may restore healthy beta cells in the pancreas, crucial for insulin production. Initial Phase II data is anticipated in the first half of 2023, potentially establishing a new treatment approach that could reduce dependence on insulin therapy.

Biomea Fusion (Nasdaq: BMEA) has received FDA clearance for its IND application for BMF-219, enabling the expansion of the COVALENT-111 study to U.S. sites. The trial evaluates BMF-219’s efficacy in treating type 2 diabetes by restoring beta cell health. The Phase I portion has been completed, showing a favorable safety and pharmacokinetics profile. Initial Phase II data is anticipated in the first half of 2023. Management will discuss the study during a conference call on December 15, 2022, at 4 PM EST, highlighting the significance of menin inhibition in diabetes treatment.

Biomea Fusion, Inc. (BMEA) has presented promising preclinical data for BMF-500, a novel covalent FLT3 inhibitor, at the 64th ASH Annual Meeting. BMF-500 exhibits picomolar affinity for FLT3 mutations and demonstrates multi-fold higher potency compared to gilteritinib. In mouse models, it led to complete tumor regression in FLT3-ITD acute myeloid leukemia, maintaining effects without continuous exposure. Biomea plans to file an IND for BMF-500 in H1 2023 and aims to initiate clinical trials soon thereafter.

Biomea Fusion, a clinical-stage biopharmaceutical company focused on covalent small molecules for genetically defined cancers and metabolic diseases, will participate in the Piper Sandler 34th Annual Healthcare Conference. This event will take place in New York, NY, on November 29, 2022, with a fireside chat scheduled for 3:30 PM ET. Investor meetings are also planned for the same day. A webcast of the fireside chat will be available on Biomea’s investor page, providing insights into their innovative therapies and development strategies.

Biomea Fusion reported its third quarter 2022 financial results, highlighting significant advancements in its clinical pipeline. The company is expanding the clinical development of BMF-219, its lead covalent menin inhibitor, now enrolling in multiple trials for liquid and solid tumors, including KRAS-mutated cancers. The cash position stood at $133.8 million. However, Biomea noted a rising net loss of $22.9 million in the quarter, up from $12.6 million in Q3 2021, primarily due to increased R&D expenses.

Biomea Fusion reported promising preclinical findings for BMF-500, its investigational covalent FLT3 inhibitor, highlighting its potential as the most potent and selective FLT3 inhibitor to date. Key results indicate that BMF-500 achieves greater cytotoxicity in acute myeloid leukemia (AML) cell lines compared to gilteritinib, and demonstrates sustained FLT3 inhibition, leading to complete tumor regression in mouse models. With around one-third of AML patients affected by FLT3 mutations, the company aims to file an IND for BMF-500 in early 2023, potentially enhancing treatment options in this critical area.

Biomea Fusion (Nasdaq: BMEA) announced a significant milestone with the dosing of the first patient in the Phase II trial of BMF-219 for type 2 diabetes. This therapy targets menin, a protein inhibiting beta cell regeneration, a critical aspect of diabetes pathology. Following a successful Phase I trial, the company plans to file an IND with the FDA to expand the trial to U.S. sites by Q4 2022. Initial Phase II data is expected in the first half of 2023, addressing a global need for innovative diabetes treatments.

Biomea Fusion (Nasdaq: BMEA) recently announced the dosing of its first patient with chronic lymphocytic leukemia (CLL) in the COVALENT-101 trial, evaluating the investigational covalent menin inhibitor BMF-219. This expanded trial aims to address the high unmet need in relapsed/refractory CLL patients. Preclinical data showed BMF-219's potent cell lethality across various CLL models, demonstrating nearly 100% efficacy even against samples resistant to standard treatments. CEO Thomas Butler emphasized the potential of BMF-219 as a transformative therapy for CLL.

Biomea Fusion has received FDA clearance for its Investigational New Drug (IND) application for BMF-219, a covalent menin inhibitor targeting KRAS solid tumors. The company will initiate a Phase I/Ib clinical trial (COVALENT-102) for patients with unresectable NSCLC, CRC, and PDAC bearing KRAS mutations. This trial expands BMF-219's scope, which also includes a Phase I trial in blood cancers. BMF-219 is notable as the first menin inhibitor entering solid tumor trials, with preclinical studies demonstrating strong anti-cancer activity against various KRAS mutations.