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Biomea Fusion, Inc. (Nasdaq: BMEA) is a clinical-stage biopharmaceutical company established in 2017 by a team of experienced biotech executives. The company is committed to the discovery, development, and commercialization of innovative small molecule drugs, specifically targeting genetically defined cancers and metabolic diseases such as diabetes. Biomea Fusion leverages its proprietary FUSION™ System, which combines internal expertise with advanced computational drug design technology to create novel medicines aimed at improving patient outcomes.
Product Pipeline and Focus
Biomea Fusion's lead product candidate, BMF-219, is an orally bioavailable, potent, and selective irreversible inhibitor of menin, a crucial transcriptional regulator implicated in oncogenic signaling in various cancers. The company is actively exploring this candidate for its potential to regenerate insulin-producing beta cells to treat diabetes. The investigational BMF-219 is currently being evaluated in several clinical studies, including COVALENT-111 for Type 2 diabetes and COVALENT-112 for Type 1 diabetes. Another promising candidate, BMF-500, is targeted at acute leukemias and is in the early stages of clinical development.
Recent Achievements
2023 was a pivotal year for Biomea Fusion, marked by positive data readouts in both Type 2 diabetes and acute myeloid leukemia (AML). The company has also begun clinical trials for Type 1 diabetes, with dosing of the first patient in the U.S. in its ongoing Phase II study, COVALENT-112. This study aims to assess the safety, efficacy, and durability of BMF-219 in potentially restoring beta cell function in adults with Type 1 diabetes.
Current Projects and Future Directions
Biomea Fusion is diligently pursuing its goal to address the root causes of diseases, particularly diabetes, by focusing on regenerating beta cells to normalize blood sugar levels naturally. The company's ongoing and upcoming clinical trials, including the multi-arm COVALENT-112 and COVALENT-111, are designed to provide robust data to support future registrational studies. In 2024, Biomea Fusion plans to complete dosing and follow-up studies for over 200 patients, which will pave the way for late-stage clinical development in both Type 2 and Type 1 diabetes.
Partnerships and Collaborations
Biomea Fusion collaborates with global research institutions and clinical sites to advance its drug candidates. The company is dedicated to building strong relationships with stakeholders to expedite the development of its therapies and ultimately improve patient lives.
Visit the Biomea Fusion website and follow the company on LinkedIn, Twitter, and Facebook for more updates on their progress and upcoming milestones.
Biomea Fusion, a clinical-stage biopharmaceutical company (Nasdaq: BMEA), announced CEO Thomas Butler's participation in the Jefferies Healthcare Conference on June 8, 2022, at 2:30 PM ET. The event will feature a fireside chat where Butler will discuss the company's innovative approach to developing covalent small molecules aimed at treating genetically defined cancers and metabolic diseases. A live webcast of the chat will be available for 90 days post-event at Biomea Fusion Investors.
Biomea Fusion (Nasdaq: BMEA) announced its participation in the American Diabetes Association Scientific Sessions, presenting pre-clinical data on BMF-219, a covalent menin inhibitor, as a potential treatment for type 2 diabetes. The presentations on June 5, 2022, highlighted BMF-219's significant and durable reduction in HbA1c levels in diabetic rat models, suggesting improved beta cell function and glycemic control compared to liraglutide. A virtual investor event on June 6 will further discuss BMF-219’s therapeutic prospects.
Biomea Fusion (BMEA) announced significant findings related to BMF-219, a novel menin inhibitor effective against chronic lymphocytic leukemia (CLL). In preclinical studies, BMF-219 demonstrated over 98% cell lethality across various CLL tumor models, particularly in high-risk patient samples with TP53 alterations and NOTCH1 mutations. Moreover, BMF-219 showed superior activity compared to standard treatments like bendamustine and ibrutinib. Currently, it is undergoing a Phase I trial (COVALENT-101) for multiple hematologic malignancies, highlighting its potential to address unmet clinical needs.
Biomea Fusion, a clinical-stage biopharmaceutical company focused on developing novel covalent small molecules, announced its participation in the H.C. Wainwright Global Investment Conference. The event will be held virtually, and Biomea will engage in 1x1 meetings organized by the conference. The company aims to target genetically defined cancers and metabolic diseases using its proprietary FUSION™ System to enhance therapeutic efficacy.
Biomea Fusion has announced its investigational product candidate, BMF-500, a third-generation covalent FLT3 inhibitor showcasing picomolar IC50 values against FLT3 isoforms, likely becoming the most potent inhibitor in its category. Initial in vivo studies have shown complete tumor regression in mouse models, indicating potential efficacy in treating acute myeloid leukemia (AML). BMF-500 is developed in-house through Biomea's proprietary FUSION™ System and may synergize with BMF-219, enhancing treatment options for AML patients with FLT3 mutations.
Biomea Fusion reported a net loss of $16.4 million for Q1 2022, up from $5.9 million in Q1 2021. R&D expenses surged to $11.4 million, up from $3.8 million, due to increased personnel and clinical costs for BMF-219, a novel covalent menin inhibitor. The company holds a cash position of $165.6 million. The COVALENT-101 study expands enrollment to include DLBCL and MM patients, while preclinical data supporting BMF-219's efficacy will be presented at ASCO and ADA Scientific Sessions.
Biomea Fusion (Nasdaq: BMEA), a clinical-stage biopharmaceutical company, announced that CEO Thomas Butler will participate in a fireside chat at the Bank of America Securities 2022 Healthcare Conference. This event will occur on May 11, 2022, at 4:00 PM Pacific Time. Investors can access a live webcast of the chat, which will be available for 90 days post-presentation. Biomea Fusion focuses on developing covalent small molecules targeting genetically defined cancers and metabolic diseases, aiming to enhance treatment efficacy and patient outcomes.
Biomea Fusion, a clinical-stage biopharmaceutical company, announced the acceptance of two abstracts for the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. These abstracts focus on the preclinical activity of the irreversible Menin inhibitor, BMF-219, in chronic lymphocytic leukemia (CLL), and details of the ongoing COVALENT-101 Phase I trial involving BMF-219 for various blood cancers. The ASCO meeting will take place from June 3-7, 2022, in Chicago, IL. Biomea aims to develop covalent small molecules targeting genetically defined cancers.
Biomea Fusion, Inc. (Nasdaq: BMEA) presented promising data for its covalent menin inhibitor, BMF-219, at the AACR Annual Meeting. The drug showed significant cytotoxic activity in various preclinical models, including diffuse large B-cell lymphoma and multiple myeloma. BMF-219 demonstrated superior potency compared to existing KRAS inhibitors, achieving over 90% growth inhibition in multiple cell lines. A Phase I study (COVALENT-101) is currently enrolling patients with relapsed/refractory cancers, indicating potential for treating significant unmet needs in oncology.
Biomea Fusion (Nasdaq: BMEA) announced acceptance of a late-breaking abstract detailing preclinical data from an in vivo study of BMF-219, aimed at treating type 2 diabetes, for presentation at the American Diabetes Association's 82nd Scientific Sessions, taking place June 3-7, 2022, in New Orleans. The company focuses on developing covalent small molecules for genetically defined cancers and metabolic diseases, which may offer advantages over conventional drugs. Further details on the presentation will be disclosed following ADA's embargo policies.