Clinical-stage biopharmaceutical company Biomea Fusion Inc. (BMEA:NASDAQ), which concentrates its work on discovering and developing covalent small molecules for use in treating genetically defined cancers and metabolic diseases, today announced that "the first patient has been dosed in the Multiple Myeloma (MM) cohort of COVALENT-101, the company's Phase I clinical trial evaluating BMF-219, Biomea's covalent menin inhibitor, in patients with R/R AML, ALL, DLBCL, and MM."
Biomea Fusion's leading lead product candidate known as BMF-219 is an oral selective covalent inhibitor of MENIN which acts as an important transcriptional regulator that effects oncogenic signaling in multiple cancers.
The company's Chief Medical Officer Steve Morris, M.D. remarked, "From the very beginning of our journey, we have been exploring and validating the broad potential of covalently inhibiting the scaffold protein, menin, in a host of liquid and solid tumors. Menin's broad role in a variety of tumor types is rather striking."
Dr. Morris continued, "Based on the outstanding translational work of our team, we have seen compelling preclinical activity using BMF-219 in MM subtypes, especially those that are driven by MYC, a protein essential to the growth of numerous tumor types."
Biomea Fusion's CEO, Chairman and Co-Founder Thomas Butler commented, "Today, we have taken the first step to explore the clinical potential of BMF-219, a single-agent covalent menin inhibitor, in treating relapsed / refractory multiple myeloma patients. This represents the second cancer type, as well as the first cancer type outside of AML, to be studied with BMF-219. We are committed to delivering innovative medicine to patients in need, including those with R/R MM."
The company indicated that the Phase 1 COVALENT-101 clinical trial is a multi-site dose escalation and expansion study designed to evaluate safety, efficacy and tolerability of a once daily oral dosing of BMF-219 in patients with relapsed or refractory (r/r) acute leukemias. The firm mentioned that the participants in the trial included subpopulations of r/r acute leukemias patients where it is believed that menin inhibition would offer strong potential for therapeutic benefit such as those patients identified with MLL1/KMT2A gene rearrangements or NPM1 mutations. Biomea advised that the scope of the trial was expanded to include additional cohorts for patients who have been diagnosed with R/R diffuse large B-cell lymphoma and R/R multiple myeloma.
The company listed that "MM is a cancer of plasma cells, which make antibodies (immunoglobulins) and are mainly located in the bone marrow." The firm stated that each year in the U.S. about 35,000 people are diagnosed with MM. The firm stated that on average, patients with MM have a 5-year relative survival rate of approximately 56%. However, in certain patients with relapsed or refractory disease where the need for treatment is the highest; overall survival can often be as little as 6 months.
Biomea Fusion is a clinical-stage biopharma firm based in Redwood City, Calif. that is working to discover and develop covalent small molecules for use in treatment of genetically defined cancers and metabolic diseases.
All of the firm's molecules are invented and created in-house using its proprietary FUSION™ System. Each of these covalent small molecules have been selected and engineered to target key mechanisms of specific disease progression in patients.
The company explained that "a covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response."
Biomea Fusion Inc. started the day with a market cap of around $261 million with approximately 29.2 million shares outstanding and a short interest of about 8.0%. BMEA shares opened 3.5% lower today at $8.64 (-$0.31, -3.46%) from yesterday's $8.95 closing price. The stock has traded today between $8.32 and $10.26 per share and closed for trading at $10.20 (+$1.25, +13.97%).
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