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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 (BMEA) reported a net loss of $41.6 million for 2021, significantly up from $5.3 million in 2020, driven by increased R&D and G&A expenses. Research and development expenses soared to $28.0 million, primarily due to costs associated with BMF-219, an irreversible covalent menin inhibitor currently in a Phase I trial. The company plans to expand trials for BMF-219 into seven cancers and diabetes, anticipating a second clinical candidate announcement in mid-2022. As of year-end 2021, cash and equivalents totaled $175.7 million, supporting future initiatives.
Biomea Fusion has appointed Dr. Steve Morris as Chief Medical Officer, who previously served as a consultant since 2020. He will lead the clinical development of BMF-219, an irreversible covalent menin inhibitor currently in a Phase I trial aimed at treating patients with specific acute leukemias. Biomea plans to expand clinical studies for BMF-219 into seven tumor types and diabetes. Dr. Morris' extensive research background includes significant contributions to the understanding of oncogenes like ALK, enhancing the company's clinical prospects in oncology.
Biomea Fusion (Nasdaq: BMEA) has initiated a Phase I clinical trial for BMF-219, the first irreversible covalent menin inhibitor aimed at treating relapsed/refractory acute leukemias. The trial involves enrolling patients with MLL1/KMT2A gene rearrangements or NPM1 mutations across 20 clinical sites in the U.S. This milestone marks Biomea's transition to a clinical stage company, with expectations for further pipeline candidates to be announced soon. Biomea aims to leverage its FUSION™ System for developing targeted therapies in oncology and metabolic diseases.
Biomea Fusion (Nasdaq: BMEA), a clinical-stage biopharmaceutical company, announced its participation at the H.C. Wainwright BioConnect Conference held from January 10-13, 2022. CEO Thomas Butler will provide a corporate update during a fireside chat. The company is focused on developing irreversible small molecules for treating genetically defined cancers and metabolic diseases, utilizing its proprietary FUSION™ discovery platform. This innovative approach aims to offer significant advantages in drug efficacy and patient outcomes.
Biomea Fusion (BMEA) plans to initiate clinical studies for its irreversible covalent menin inhibitor, BMF-219, targeting seven cancer indications and diabetes in 2022. The company aims to file an Investigational New Drug (IND) application within 12 months for their second program. BMF-219 has shown promising results in preclinical studies, effectively inhibiting menin-dependent oncogenic signaling and normalizing glucose levels in diabetic models. Clinical trials for liquid tumors and diabetes are set to commence in 2022, reflecting Biomea's strategic focus on novel treatments for genetically defined cancers.
Biomea Fusion (Nasdaq: BMEA) announced that its irreversible menin inhibitor, BMF-219, demonstrated significant efficacy in animal models for type 2 diabetes. In studies using Zucker Diabetic Fatty rats and Streptozotocin-Induced Diabetes models, BMF-219 normalized glucose levels in most subjects after two weeks. These effects persisted even post-treatment, indicating the compound's potential as a groundbreaking diabetes treatment. Biomea plans to discuss the next steps, including a Phase 1/2 clinical trial, with regulators this quarter, showcasing the promising capabilities of BMF-219 in addressing Beta-cell dysfunction.
Biomea Fusion, Inc. (Nasdaq: BMEA) has relocated its headquarters to a new 27,000 sq. ft. facility in Redwood City, California, enhancing its operational capabilities. The move supports the company’s growth initiatives for 2022 and beyond. Additionally, Biomea is expanding its R&D Innovation Center by 18,000 sq. ft., expected to be complete in the second half of 2022, to focus on biology, medicinal chemistry, and drug research. Biomea is committed to developing irreversible small molecules for treating genetically defined cancers, aiming to be a leader in this field.
Biomea Fusion, a clinical-stage biopharmaceutical company focused on innovative cancer treatments, announced its participation in the 40th Annual J.P. Morgan Healthcare Conference. CEO Thomas Butler will present on January 12, 2022, at 12:00 PM PT. The presentation will highlight Biomea's proprietary FUSION™ platform, aimed at developing irreversible small molecules for genetically defined cancers, offering potential advantages such as greater selectivity and durability. A live audio webcast will be available on the company's website for 30 days post-presentation.
Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company focused on irreversible small molecules for genetically defined cancers, has been added to the NASDAQ Biotechnology Index, effective December 20, 2021. This index includes NASDAQ-listed companies in the Biotechnology and Pharmaceuticals sectors that meet specific criteria. Biomea’s proprietary FUSION™ discovery platform aims to enhance treatment selection, potentially improving patient outcomes through more selective and durable drug responses.
Biomea Fusion, a clinical-stage biopharmaceutical company (Nasdaq: BMEA), announced participation in two virtual conferences. CEO Thomas Butler will present at the Jefferies London Healthcare Conference on November 18 at 3:00am ET and at the Piper Sandler 33rd Annual Virtual Healthcare Conference on November 22 at 10:00am ET. Biomea will also conduct 1x1 investor meetings during these events. The company is advancing BMF-219, an irreversible inhibitor targeting genetically defined leukemias, into a first-in-human trial.
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