Icovamenib met the primary endpoint, displaying a meaningful statistically significant placebo-corrected mean reduction in HbA1c in the prespecified per protocol patient population Best response achieved in target, beta-cell deficient patients on one or more antidiabetic agents at baseline, showing a placebo-adjusted mean reduction of 1.47% in HbA1c at Week 26 with statistical significance, after only 12 weeks of dosing... Read More

REDWOOD CITY, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced that it will host a conference call and webcast on Tuesday, December 17, 2024 at 8:00 am EST to... Read More

In preclinical experiments, icovamenib enhanced beta cell function and responsiveness of human islets to GLP-1-based therapies. These effects were associated with an increase in the expression levels of both the GLP-1 receptor (GLP-1R) as well as intracellular insulin. Overall results showed synergy of the combination therapy, which may allow lower doses of GLP-1-based therapies to achieve glycemic targets, potentially... Read More

Preliminary data supports BMF-500’s potential as a transformative therapy for patients with FLT3 mutated relapsed or refractory (R/R) acute leukemia BMF-500 showed a favorable safety and tolerability profile, with no dose-limiting toxicities observed across all dose levels Pharmacokinetic and pharmacodynamic data confirmed on-target FMS-like tyrosine kinase 3 (FLT3) inhibition, demonstrating dose-proportional activity and... Read More

REDWOOD CITY, Calif., Dec. 06, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced that it will host a conference call and webcast on Monday, December 9, 2024 at 4:30 pm EST to... Read More

REDWOOD CITY, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA) (“Biomea” or the “Company”), a clinical stage biopharmaceutical company focused on the discovery and development of oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced that on December 2, 2024, the compensation committee of Biomea’s board of... Read More

Icovamenib Achieves a Mean Reduction in HbA1c Greater than 1% at Week 26 Following 4 Weeks of Dosing in Type 2 Diabetes Patients Characterized by Insulin Deficiency 32 patients from the 100mg and 200mg cohorts, doses selected for the expansion phase, were characterized based on baseline biomarkers and analyzed for efficacy. Patients identified as insulin deficient (approx. 50% of the broader patient population) and insulin... Read More

REDWOOD CITY, Calif., Nov. 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA) (“Biomea” or the “Company”), a clinical stage biopharmaceutical company focused on the discovery and development of oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced that on November 1, 2024, the compensation committee of Biomea’s board of... Read More

Preclinical data from ex vivo human islet experiments showed that icovamenib (BMF-219) was able to enhance the activity of glucagon-like peptide-1 (GLP-1)-based therapies, potentially leading to increased insulin secretion and improved glycemic control in patients with diabetes Phase II study (COVALENT-211), combining icovamenib with a GLP-1-based therapy, planned to begin in 2025 BMF-650, an investigational next-generation,... Read More

U.S. Food and Drug Administration (FDA) lifted Clinical Hold on COVALENT-111 (Type 2 Diabetes) & COVALENT-112 (Type 1 Diabetes) trials COVALENT-111 Phase 2b 26-week topline data of the dose expansion cohorts expected in December 2024 COVALENT-112 Phase 2a 26-week topline data of the open label portion expected in December 2024 On track to announce our third clinical candidate, BMF-650, for the treatment of diabetes and... Read More

REDWOOD CITY, Calif., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced that the World Health Organization (WHO) has approved “icovamenib” as the International... Read More

REDWOOD CITY, Calif., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced that it will host a conference call and webcast on Wednesday, October 30th at 4:30 pm ET to... Read More

BMF-219 is an investigational oral covalent menin inhibitor developed to regenerate insulin-producing beta cells Two trial-in-progress oral presentations to feature Phase II study design of oral covalent menin inhibitor BMF-219 in patients with type 2 diabetes (COVALENT-111) and in patients with type 1 diabetes (COVALENT-112) One late breaker oral presentation to highlight two case studies assessing BMF-219 in persons with... Read More

REDWOOD CITY, Calif., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with metabolic diseases, obesity and genetically defined cancers, today announced the formation of Biomea Fusion’s Global Scientific Advisory Board (SAB) with... Read More

REDWOOD CITY, Calif., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or the “Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold... Read More

REDWOOD CITY, Calif., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA) (“Biomea” or the “Company”), a clinical stage biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with metabolic diseases and genetically defined cancers, today announced that on August 1, 2024, the compensation committee of Biomea’s board of directors granted one new... Read More

COVALENT-111 Phase 2b on track for Q4 2024 readout COVALENT-112 Phase 2a on track for Q4 2024 readout Announcement of the third program in obesity on track for Q3 2024 REDWOOD CITY, Calif., July 31, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “the Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the... Read More

REDWOOD CITY, Calif., June 06, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or the “Company”) (Nasdaq: BMEA), announced that the Company has received notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold has been placed on Biomea’s ongoing Phase I/II clinical trials of the Company’s investigational covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes (COVALENT-111 and... Read More

REDWOOD CITY, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA) (“Biomea” or the “Company”), a clinical stage biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases, today announced that on June 1, 2024, the compensation committee of Biomea’s board of directors granted one new employee... Read More

REDWOOD CITY, Calif., May 30, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced the completion of enrollment of the first three dose expansion arms of COVALENT-111, with a total... Read More

Reported positive data from the escalation portion of Phase 1/2 study (COVALENT-111) in type 2 diabetes patients, displaying durable improved glycemic control while off therapy for 22 weeks, supporting the disease-modifying potential of BMF-219 to address a root cause of diabetes: a loss of healthy, insulin-producing beta cells Announced initial clinical data from our Phase 2 study (COVALENT-112) in type 1 diabetes from the... Read More

REDWOOD CITY, Calif., May 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc . (Nasdaq: BMEA) (“Biomea” or the “Company”), a clinical stage biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases, today announced that on May 1, 2024, the compensation committee of Biomea’s board of directors granted 8 new employees... Read More

REDWOOD CITY, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA) (“Biomea” or the “Company”), a clinical stage biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases, today announced that on April 1, 2024, the compensation committee of Biomea’s board of directors granted two new... Read More

BMF-219 is an investigational novel covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure diabetes The first two type 1 diabetes patients enrolled in COVALENT-112 both demonstrated early signs of clinical activity with improved measures of beta-cell function after initial treatment with BMF-219 BMF-219 has been well tolerated by both patients Open label portion of Phase II... Read More

In 2023, reported Phase 2 data (COVALENT-111) in type 2 diabetes patients supporting the disease-modifying potential of BMF-219 to address a root cause of diabetes: a loss of healthy, insulin-producing beta cells. After just a 4-week treatment period in type 2 diabetes patients, who had previously failed standard of care (HbA1c > 7.0% and < 10%), BMF-219 demonstrated continued glycemic control at 26 weeks, or five months,... Read More

Three Clinical Data Sets from the Dose Escalation Phase of COVALENT-111 to be Presented at the 17 th Annual ATTD Conference Highlighting BMF-219’s Novel Mechanism of Action in Patients with Type 2 Diabetes Patients in COVALENT-111 are displaying improved glycemic control while off therapy out to Week 26 following the 28-day treatment with BMF-219, supporting enhanced pancreatic islet function as the mechanism of action... Read More

REDWOOD CITY, Calif., March 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA) (“Biomea” or the “Company”), a clinical stage biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases, today announced that on March 1, 2024, the compensation committee of Biomea’s board of directors granted two new... Read More

Expansion portion of Phase II COVALENT-111 study readout in 216 patients with type 2 diabetes expected in 2024. Open label portion of Phase II COVALENT-112 study readout in 40 patients with type 1 diabetes expected in 2024. REDWOOD CITY, Calif., Jan. 09, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small... Read More

The clinical study, COVALENT-112, has initiated enrollment of adults living with type 1 diabetes in the US and Canada. Eligible patients include those who have been diagnosed with type 1 diabetes for up to 15 years. Data from the Phase II study are expected in 2024. REDWOOD CITY, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc . (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to... Read More

REDWOOD CITY, Calif., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today announced that Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board, will... Read More

BMF-219 demonstrated early signs of clinical activity and ability to achieve durable and sustained complete responses (CRs) with minimal residual disease negativity (MRD-neg) in acute myeloid leukemia (AML) patients Pharmacodynamic data further supports the mechanism of action of BMF-219 as a menin inhibitor; in-line with preclinical models, BMF-219 downregulated key leukemogenic genes (e.g. HOXA9, MEIS1) as well as MEN1... Read More

At Week 26, 22 weeks after the last dose of BMF-219, the 200 mg cohorts increased the percentage of patients to approximately 40% with durable HbA1c reduction of 1% or more as compared to the 100 mg cohorts which reported earlier as 20%. To date, the dose escalation portion has shown after only 4 weeks of dosing with BMF-219 that patients across all dosing cohorts have consistently experienced generally meaningful HbA1c... Read More

BMF-219 is an investigational novel covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure diabetes At Week 26, 22 weeks after the last dose of BMF-219, participants in the 100 mg QD (without food) cohort saw an improved placebo adjusted mean reduction in HbA1c of 0.8% (compared to a 0.7% placebo adjusted mean reduction in HbA1c at Week 4) Observed HbA1C reduction was supported by... Read More

BMF-219 is an investigational novel covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure diabetes In a poster presentation on Thursday, Dec. 7 th at 6:30pm and an oral presentation on Friday, Dec. 8 th at 7:30pm, Biomea to present new preclinical and clinical data highlighting: A sustained HbA1C reduction of ≥0.5% and ≥1.0% in 40% and 20% of patients, respectively, 22 weeks after... Read More

BMF-219 is a novel investigational covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure diabetes Health Canada has cleared the initiation of COVALENT-112, a Phase II clinical trial of BMF-219 in adults living with type 1 diabetes (T1D), following FDA clearance of the initiation of COVALENT-112 in October 2023 The randomized, double-blind, placebo-controlled (n=150) trial in... Read More

New clinical data from all dosing cohorts (n=62) initiated to date from the escalation portion of COVALENT-111 and long-term (26 weeks) follow-up data of the 200 mg dosed cohorts will be featured during an oral Poster Discussion Presentation and two Poster Viewing Presentations at ATTD REDWOOD CITY, Calif., Nov. 27, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical... Read More

New clinical data providing long-term 26 weeks follow-up of the initial two dosing cohorts of COVALENT-111 will be presented during the Abstract Oral Presentation Session at WCIRDC meeting on Friday, Dec 8, 2023 at 7:30 pm – 9:00 pm PST in Los Angeles Biomea will kick-off the WCIRDC meeting by hosting a congress symposium titled, “BMF-219: An oral menin inhibitor in clinical development as a short-term treatment to address... Read More

An abstract, “BMF-219: A novel therapeutic agent to reestablish functional beta cells and provide long-term glycemic control” will be presented during the WCIRDC meeting held in Los Angeles, December 7-9, 2023 Additionally, Biomea will hold new investigator educational meeting during WCIRDC to discuss the role of menin as a regulator of glycemic control and beta-cell mass, and to illustrate the mechanism of action of... Read More

First presentation of clinical data from ongoing COVALENT-101 trial of covalent menin inhibitor BMF-219 as a treatment for patients with liquid tumors Trial in progress presentation featuring study design of ongoing COVALENT-103 trial of covalent FLT3 inhibitor BMF-500 REDWOOD CITY, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “the company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical... Read More

Demonstrated durable HbA1c lowering in the escalation portion of ongoing Phase II study in type 2 diabetes (COVALENT-111), with 84% of all patients showing a reduction of HbA1c after 4 weeks dosing and 74% after another 8 weeks off-treatment period Expansion portion of COVALENT-111 cleared and actively enrolling in the U.S. and Canada; expected to enroll approximately 200 adults with type 2 diabetes Investigational new drug... Read More

BMF-500, a novel 3 rd generation oral covalent inhibitor of FMS-like tyrosine kinase 3 (FLT3), is the second product candidate discovered and developed by Biomea’s proprietary FUSION™ System to enter the clinic Phase I study (COVALENT-103) of BMF-500 will examine monotherapy safety and efficacy in adult patients with relapsed or refractory acute leukemia with FLT3 wild-type and FLT3 mutations, including those with... Read More

The FDA has cleared the initiation of COVALENT-112, a Phase II clinical trial of BMF-219 in adults with type 1 diabetes (T1D). The randomized, double-blind, placebo-controlled (N=150) trial in adults with T1D will examine the safety and efficacy of BMF-219 at two oral dose levels, 100 mg and 200 mg unfed, for 12-weeks of treatment followed by a 40 week off-treatment period. REDWOOD CITY, Calif., Oct. 05, 2023 (GLOBE... Read More

The FDA and Health Canada have cleared the initiation of the expansion portion of COVALENT-111, which will evaluate BMF-219 administered at 100 mg and 200 mg, with dosing durations up to 12 weeks in type 2 diabetes patients The expansion portion will consist of approximately 300 patients and will begin to enroll three cohorts immediately, with a fourth cohort following the completion of the escalation portion Compared to... Read More

Industry veteran and prominent diabetes clinical development expert to oversee Biomea’s progressing clinical development of novel covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes Steve Morris, M.D., will transition to the role of Chief Development Officer, continuing to lead clinical development of Biomea’s oncology portfolio, including BMF-219, BMF-500 and research-stage assets REDWOOD CITY, Calif., Aug. 31,... Read More

Reported additional positive clinical data at ADA 83 rd Scientific Sessions from the first two cohorts of patients with type 2 diabetes from ongoing Phase I/II study (COVALENT-111) evaluating BMF-219 as a novel, potentially disease-modifying treatment candidate for patients with type 2 diabetes New data highlighted specific patients treated with BMF-219 for 4 weeks maintained or experienced a further decrease in HbA1c levels... Read More

Initial topline data from COVALENT-101 trial revealed 2 complete responses (CRs) out of 5 relapsed/refractory AML patients carrying menin-dependent mutations treated at Dose Level 4 Dose Level 4 exposure correlates with initial activity seen in BMF-219’s pre-clinical studies Safety profile of BMF-219 supports further dose escalation; enrollment for Dose Level 5 has commenced to explore the optimal biological dose BMF-219,... Read More

Eight weeks after completing treatment with BMF-219, patients with type 2 diabetes (T2D) showed an increase of C-peptide and an improvement of HOMA-B, measured during oral glucose tolerance testing (OGTT), supporting improved beta cell function for these patients Observations of durable and continued improvement in glycemic control were seen in follow-up visits through Week 12 compared to Week 4, eight weeks after the last... Read More

New clinical data from COVALENT-111 will be unveiled during a late-breaking poster presentation at ADA’s Scientific Sessions BMF-219, an orally delivered novel covalent menin inhibitor, is designed to regenerate, preserve, and reactivate healthy, insulin-producing beta cells Biomea to hold in-person KOL investor event at the Scientific Sessions in San Diego on Saturday, June 24 th at 5:30 pm PT Biomea to hold conference call... Read More

Reported initial positive clinical data from first two cohorts of Phase II of ongoing Phase I/II study (COVALENT-111) of BMF-219, Biomea’s lead investigational, orally administered covalent menin inhibitor, as a novel, potentially disease-modifying treatment for patients with type 2 diabetes Continued enrolling four liquid tumor cohorts in ongoing Phase I study of BMF-219 (COVALENT-101), each focused on distinct patient... Read More

BMF-500, a novel 3 rd generation covalent inhibitor of fms-like tyrosine kinase 3 (FLT3), is the second investigational compound, discovered and developed by Biomea’s FUSION™ System, to advance to the clinic. Phase I study (COVALENT-103) of BMF-500 will examine its safety and efficacy in patients with relapsed or refractory acute leukemia with FLT3 wild-type and FLT3 mutations, including those with MLLr / NPM1 mutations.... Read More

New clinical data from COVALENT-111 will be featured during the Late-Breaking Poster Presentations at the Scientific Sessions Biomea to hold an investor and KOL event during the Scientific Sessions REDWOOD CITY, Calif., April 19, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and... Read More

Abstract 473 highlights the dose dependent reduction of menin target genes in ex vivo chronic lymphocytic leukemia (CLL) patient samples treated with BMF-219, an investigational covalent inhibitor. BMF-219 showed greater potency and ability to achieve >98% growth inhibition in these CLL patient samples in comparison with reversible BTK inhibitor, pirtobrutinib, and irreversible BTK inhibitor, ibrutinib. Abstract 4939... Read More

REDWOOD CITY, Calif., April 13, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or the “Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today announced the closing of its previously announced upsized underwritten public offering... Read More

REDWOOD CITY, Calif., March 29, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today announced the pricing of its previously announced underwritten public offering of 5,000,000 shares of... Read More

REDWOOD CITY, Calif., March 29, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, announced today that it has commenced an underwritten public offering of $125.0 million of shares of its... Read More

Expanded clinical development footprint of BMF-219, the company’s lead investigational, orally administered, covalent menin inhibitor, to eight liquid and solid tumor indications and type 2 diabetes across three ongoing clinical trials COVALENT-101 (Phase I study) enrolling four liquid tumor cohorts, each focused on distinct patient subsets of acute lymphocytic and myeloid leukemias (ALL/AML) including patients with MLL... Read More

In Cohort 3, after 4 weeks of once-daily 100 mg dosing with the investigational, oral covalent menin inhibitor, BMF-219, 89% of patients achieved a reduction in A1c, 78% of patients achieved at least a 0.5% reduction in A1c, and 56% achieved at least a 1% reduction in A1c. Initial observations of continued glycemic control were seen in follow up visits in patients that had already reached week 8 in the study (4 weeks after... Read More

REDWOOD CITY, Calif., March 23, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today announced that it will host a conference call and webcast to discuss the initial clinical data from the... Read More

REDWOOD CITY, Calif., March 02, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases, today announced that Biomea’s management is scheduled to host investor meetings and participate in the following upcoming events: A virtual fireside... Read More

BMF-219 is the first menin inhibitor to be clinically studied in patients with KRAS-mutated non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) A pan-KRAS inhibitor targeting multiple KRAS mutations (including G12C, G12D and G12R, among others) has the potential to treat 25-35% of NSCLC patients, 35-45% of CRC patients, and approximately 90% of PDAC patients BMF-219 is now... Read More

REDWOOD CITY, Calif., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ( Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today announced that Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board, will present... Read More

COVALENT-111, now underway in the US, has completed Phase I and is currently enrolling type 2 diabetes patients in the Phase II randomized, placebo-controlled portion of the trial BMF-219, an orally available covalent menin inhibitor, is being evaluated for its potential to enable the proliferation, preservation, and reactivation of healthy, functional beta cells capable of producing insulin, thereby leading to long-term... Read More

COVALENT-111, a Phase I/II clinical trial in patients with type 2 diabetes, already underway in Canada, will now activate sites in the US As previously reported, the Phase I portion of COVALENT-111 has been completed, with BMF-219 demonstrating a favorable safety, pharmacokinetics (PK) and pharmacodynamics (PD) profile Ongoing Phase II portion is evaluating BMF-219’s long-term glycemic control by restoring the pool and... Read More

BMF-500, an investigational third generation covalent FLT3 inhibitor, demonstrated preclinically: Picomolar affinity to activating FLT3 mutations including FLT3-ITD and various tyrosine kinase domain (TKD) mutations Multi-fold higher potency and increased cytotoxicity than commercially available non-covalent FLT3 inhibitor gilteritinib Complete tumor regression in mouse models of FLT3-ITD acute myeloid leukemia (AML) and... Read More

BMF-219 is the first menin inhibitor to reach the clinic for type 2 diabetes. The Phase II portion of COVALENT-111 is designed to examine the capacity of BMF-219 to provide long-term glycemic control by restoring the patient’s pool of beta cells Beta cell loss is a critical component of the etiology and pathogenesis of type 1 and type 2 diabetes; menin is thought to function as the brakes on beta cell recovery in the... Read More

COVALENT-101 now includes patients with relapsed/refractory (R/R) CLL BMF-219 is the first menin inhibitor in the clinic for CLL Preclinical data presented at ASCO 2022 demonstrated the potency of BMF-219, a covalent menin inhibitor, across varying cytogenetic risk profiles and Rai stages, indicating broad activity with over 98% cell lethality in these CLL models at clinically achievable concentrations R/R CLL patient... Read More

Biomea Fusion announces FDA clearance of Investigational New Drug (IND) application for covalent menin inhibitor BMF-219 in KRAS solid tumors. Biomea Fusion will now initiate a Phase I/Ib clinical trial (COVALENT-102) of BMF-219 as a monotherapy in patients who have unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC), colorectal cancer (CRC) or pancreatic ductal adenocarcinoma (PDAC) with a KRAS... Read More

Treatment with BMF-219 led to an increase in beta cell mass in ex-vivo experiments with human donor islets BMF-219 showed improved pancreatic beta-cell function and beta cell area, insulin sensitivity, blood lipid levels, weight decline, and glycemic control in the rat models (ZDF (Zucker Diabetic Fatty Rat) and the STZ (streptozotocin)) during the dosing period, and importantly, both glycemic and lipemic control were... Read More

Menin, a transcriptional scaffold protein, regulates pancreatic beta cell homeostasis; inhibiting menin function with BMF-219 increased beta cell function in a preclinical animal model, driving an improvement in glycemic control and insulin sensitivity. New data presented in a Short Oral Discussion, at EASD in Stockholm, Sweden, highlights the ability of BMF-219, a covalent menin inhibitor, to restore normal HOMA-B, a... Read More

Data demonstrated robust anti-tumor activity of BMF-219 and mechanistic evidence for novel inhibition of menin protein in preclinical models of Diffuse Large B-cell Lymphoma (DLBCL) and multiple myeloma (MM). BMF-219 displayed single agent potency, surpassing greater than 90% inhibition at clinically relevant exposures in both DLBCL and MM cell lines and patient-derived samples. A Trial In Progress (TIP) poster was also... Read More

Continued to make significant progress advancing BMF-219, the company’s lead investigational orally administered covalent menin inhibitor, in multiple oncology indications COVALENT-101 (Phase I) study is enrolling for patients with Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Diffuse Large B-cell Lymphoma (DLBCL), and Multiple Myeloma (MM) On track to submit IND for BMF-219 in solid tumors, including... Read More

Biomea to present two oral abstracts across multiple animal models highlighting the ability of BMF-219, a covalent menin inhibitor, to significantly lower HbA1C (approximately two-fold greater reduction than active control, liraglutide) and to increase beta cell function. BMF-219 showed prolonged glycemic control in two standard diabetes animal models, the Zucker Diabetic Fatty (ZDF) and Streptozotocin-induced (STZ) Rat... Read More

BMF-219, a covalent menin inhibitor, is the first menin inhibitor administered to patients with relapsed/refractory (R/R) multiple myeloma (MM) Patients with R/R MM and R/R diffuse large B-cell lymphoma (DLBCL) are eligible for enrollment in COVALENT-101 Enrollment continuing for both acute leukemia cohorts, including AML and ALL, while initiating DLBCL and MM patient cohorts Site activation continuing in North America... Read More

Menin acts as a ‘brake’ on beta cell regeneration; inhibiting menin function with BMF-219 may increase beta cell production and function, thereby increasing insulin levels and controlling high glucose levels BMF-219, a covalent menin inhibitor, showed strong, prolonged glycemic control, insulin sensitization, and hemoglobin A1C (HbA1c) reduction in the streptozotocin (STZ) beta-cell ablation and zucker diabetic fatty (ZDF)... Read More

Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, announced that Thomas Butler, Chief Executive Officer and Chairman of the Board, will participate in a fireside chat and meet with investors at the in-person Jefferies Healthcare... Read More

Company to host virtual investor R&D event on Monday, June 6, 2022 at 4:05 PM EDT featuring covalent menin inhibitor, BMF-219, as a potential novel treatment for type 2 diabetes Biomea Fusion, Inc . (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases,... Read More

BMF-219 is the first investigational menin inhibitor in clinical development to show potential as a therapeutic agent for CLL BMF-219, a covalent menin inhibitor, demonstrated potency across ex vivo CLL tumor models with varying cytogenetic risk profiles and Rai stages, indicating broad activity with over 98% cell lethality in these models High- and intermediate-risk cytogenetic profile ( TP53 alterations and NOTCH1... Read More

Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, announced that Biomea will attend the H.C. Wainwright Global Investment Conference virtually and will participate in 1x1 meetings held by the conference organizers. About Biomea... Read More

BMF-500, an investigational third-generation covalent inhibitor of FLT3, demonstrated picomolar IC 50 values across key FLT3 isoforms, potentially making it the most potent inhibitor of its class Highly selective for FLT3, BMF-500 was observed to avoid other type III receptor tyrosine kinase (RTK) family members, including cKIT, which drives myelosuppression and limits utility of some first and second-generation FLT3... Read More

COVALENT-101 study continues to enroll relapsed/refractory (R/R) acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL) patients and has included R/R diffuse large B-cell lymphoma (DLBCL) and R/R multiple myeloma (MM) patients to the study. Company continues to explore indication expansion with the announced upcoming presentation of preclinical ex vivo data of BMF-219 in Chronic Lymphocytic Leukemia (CLL) at the... Read More

Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, announced that Thomas Butler, Chief Executive Officer and Chairman of the Board, will participate in a fireside chat at the live Bank of America Securities 2022 Healthcare... Read More

Biomea to present preclinical data in chronic lymphocytic leukemia (CLL) and Trial In Progress (TIP) information for its ongoing COVALENT-101 Phase I trial Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, announced the... Read More

Covalent menin inhibitor BMF-219 showed strong cytotoxic activity as a single agent at similar concentrations across multiple preclinical patient derived (PDX) models ex vivo , including diffuse large B-cell lymphoma (DLBCL), multiple myeloma (MM), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and pancreatic cancer Single agent BMF-219 demonstrated pronounced anti-cancer activity in vitro across KRAS G12C,... Read More

Biomea to present additional preclinical data from an in vivo study of BMF-219 in type 2 diabetes Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today announced that a late breaking abstract has been accepted at the... Read More

Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today announced that it is scheduled to participate in a fireside chat at the Oppenheimer 32 nd Annual Virtual Healthcare Conference on Wednesday, March 16,... Read More

Biomea to present preclinical data from multiple in vivo studies Biomea plans to initiate a Phase I/II clinical trial of BMF-219 in diabetes in the second half of 2022, subject to submission and clearance of an investigational new drug (IND) application Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible covalent small molecules to... Read More

Irreversible covalent menin inhibitor, BMF-219, exhibited high potency and complete growth inhibition in high-grade B-cell lymphoma and multiple myeloma (MM) preclinical patient derived ex vivo models BMF-219 demonstrated high potency in various KRAS-mutant cell lines, as well as potential advantages over the KRAS-targeted inhibitor sotorasib in multiple cell lines BMF-219 showed strong potency in ex vivo preclinical models... Read More

Phase I trial of BMF-219, an irreversible covalent menin inhibitor, is currently underway Plan to initiate trials of BMF-219 in up to seven solid and liquid tumor types and diabetes Plan to announce second clinical candidate in the first half of 2022 Cash, cash equivalents, restricted cash, and investments of $175.7 million Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to... Read More

BMF-219 is the first irreversible covalent menin inhibitor to enter the clinic Phase I trial is enrolling patients with relapsed/refractory acute leukemias, including those with MLL1/KMT2A gene rearrangements or NPM1 mutations Phase I trial is expected to include up to 20 clinical sites at leading US medical centers Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), today announced that the first patient has been dosed in its... Read More

Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today announced it will be featured as a presenting company at the H.C. Wainwright BioConnect Conference. The conference is being held on January 10-13,... Read More

Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, announced today that in 2022 it plans to initiate clinical studies to dose its irreversible covalent menin inhibitor, BMF-219, in up to seven different... Read More

Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of irreversible small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, announced today that BMF-219 displayed remarkable activity in both the Zucker Diabetic Fatty (ZDF) Rat and the Streptozotocin-Induced Diabetes (STZ) animal models... Read More

Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genetically defined cancers, announced that it has moved into new headquarters in Redwood City, at 900 Middlefield Road. Located in the heart of Redwood City, within the Crossing 900 development, the new... Read More

Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genetically defined cancers, announced that it will present at the upcoming virtual 40 th Annual J.P. Morgan Healthcare Conference. Thomas Butler, Chief Executive Officer and Chairman of the Board, is... Read More

Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genetically defined cancers, today announced that the company has been selected for addition to the NASDAQ Biotechnology Index (Nasdaq: NBI), effective prior to market open on Monday, December 20, 2021. The... Read More

Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genetically defined cancers, today announced that Thomas Butler, Chief Executive Officer and Chairman of the Board, will participate in two upcoming virtual conferences. Jefferies London Healthcare Conference... Read More

BMF-219 displays global disruption of menin, highlighting ‘219’s novel mechanism of action Molecule elicits broad impact on the complexes surrounding menin, resulting in strong modulation of MYC expression, highlighting potential in multiple cancer types BMF-219 demonstrated potent preclinical efficacy in diffuse large B cell... Read More

Announced FDA clearance of Investigational New Drug Application (IND) for BMF-219, the company’s first development candidate from the FUSION platform Phase I trial to enroll adult patients with relapsed or refractory acute leukemia, including those with an MLL/KMT2A gene rearrangement or NPM1 mutation Scientific rationale for irreversible menin inhibition in diffuse large B cell lymphoma (DLBCL) now expected in Q4 2021... Read More

Biomea Fusion to transform to a Clinical Stage Company with First in Human (FIH) Clinical Trial BMF-219 advances as the first clinical stage therapeutic from the company’s deep pipeline of covalent irreversible small molecules BMF-219 is a novel, first-in-class, irreversible menin inhibitor designed to control menin’s negative impact across several indications FIH Study will initially enroll patients with relapsed/refractory... Read More

Completed investigational new drug (“IND”) enabling studies for lead program, BMF-219, an irreversibly binding menin inhibitor. On track to complete IND submission for Phase I/II study of BMF-219 as treatment for patients with menin-dependent acute myeloid leukemia (“AML”) and acute lymphocytic leukemia (“ALL”) during the second half of this year Continued to advance ongoing preclinical studies of BMF-219 in a number of... Read More

Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a preclinical-stage biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers, announced the appointment of Franco Valle as Chief Financial Officer. Mr. Valle is an accomplished financial expert who brings extensive experiences to Biomea, in particular with building the necessary... Read More

Received $167 million in aggregate gross proceeds in April from initial public offering Advancing lead oncology program BMF-219, a small molecule irreversible menin inhibitor, toward IND filing in second half of 2021 Mick Hitchcock, Ph.D., former senior advisor to Gilead joined the Board of Directors Biomea Fusion, Inc . (“Biomea”) (Nasdaq: BMEA), a preclinical-stage biopharmaceutical company focused on the discovery and... Read More

Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a preclinical-stage biopharmaceutical company focused on the discovery, development and commercialization of irreversible small molecules to treat patients with genetically defined cancers, today announced the closing of its initial public offering of 9,000,000 shares of its common stock at a public offering price of $17.00 per share. All of the shares of common stock were... Read More