BIOMEA FUSION, INC.


Associated tags: Patient, Fusion, Cancer, DSM-IV codes, Pharmaceutical industry, Diabetes, Osteopathic medicine in Canada, Safety, IND, Research

Locations: PK, RA, ONTARIO, VANCOUVER, REDWOOD CITY, CA, US

Biomea Fusion to Present at 41st Annual J.P. Morgan Healthcare Conference and Highlight 2023 Corporate Milestones

Retrieved on: 
Monday, January 9, 2023
IND, NSCLC, Large-cell lung carcinoma, Menin, Cancer, CRC, Glycated hemoglobin, Lymphatic system, MM, Multiple myeloma, Colorectal cancer, Team, Death, Liraglutide, Safety, CLL, FDA, Pancreatic cancer, Mutation, PDAC, Maintenance, Acute leukemia, Conference, NPM1, ET, Chronic lymphocytic leukemia, Patient, MLL, Type 2, KRAS, Type 2 diabetes, Phase, FLT3, Diabetes, Pharmaceutical industry, Medical imaging, DLBCL, Osteopathic medicine in Canada

A live webcast of the presentation will be available on the Investors & Media page of Biomea’s website at: https://investors.biomeafusion.com/news-events/events .

Key Points: 
  • A live webcast of the presentation will be available on the Investors & Media page of Biomea’s website at: https://investors.biomeafusion.com/news-events/events .
  • “2022 was a year of strong execution and fundamental infrastructure build as we transitioned to a clinical-stage company and expanded our pipeline.
  • In addition, we anticipate initiating dosing imminently in our Phase I/Ib (COVALENT-102) study of BMF-219 in patients with KRAS-mutated solid tumors.
  • On track to announce a third development candidate from the FUSION platform in the first half of 2023.

Biomea Fusion Announces Dosing of First Patient with Type 2 Diabetes in the United States in Ongoing Phase I/II (COVALENT-111) Study of BMF-219

Retrieved on: 
Wednesday, January 4, 2023
PD, Cancer, Pancreas, Adequate stimulus, Pharmacokinetics, Insulin, Patient, Safety, FDA, IND, Phase, Diabetes, Pharmaceutical industry

“We are thrilled to announce this milestone so soon after receiving IND clearance from the FDA in December.

Key Points: 
  • “We are thrilled to announce this milestone so soon after receiving IND clearance from the FDA in December.
  • BMF-219 is potentially capable of addressing and modifying a major driver of type 2 diabetes, beta cell health and function.
  • Low beta cell mass is a root cause of type 2 diabetes; without enough healthy, functional beta cells, people with type 2 diabetes are unable to produce sufficient amounts of insulin.
  • Preclinical studies have shown the potential of BMF-219 to restore and balance beta cells mass.

Biomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for Covalent Menin Inhibitor BMF-219 in Type 2 Diabetes

Retrieved on: 
Wednesday, December 14, 2022
Life, Phase, Hyperglycemia, Clinical uses of mesenchymal stem cells, Internet, United, Health, PD, Insulin, Medicine, Prediabetes, Degenerative disease, Osteopathic medicine in Canada, Food, FDA, Microdeletion syndrome, Safety, Cancer, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmacokinetics, CDC, Diabetes, Regeneration, Drug Quality and Security Act, Natural history, Growth, Type 2 diabetes, Research, IND, PK, Pancreas, Disease, Risk, Institutional review board, TEAM, Patient, Pharmaceutical industry

“I would like to thank all involved for their considerable guidance and collaboration throughout the preparation and submission of this application.

Key Points: 
  • “I would like to thank all involved for their considerable guidance and collaboration throughout the preparation and submission of this application.
  • The ongoing Phase II portion consists of multiple ascending dose cohorts and includes adult patients with type 2 diabetes uncontrolled by current therapies.
  • Biomea Fusion is a leader in advancing next-generation covalent small molecule medicines designed to maximize clinical benefit to treat various cancers and metabolic diseases.
  • Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Biomea Fusion Presents at the 2022 ASH Annual Meeting Preclinical Data on BMF-500 Supporting its Potential as the Most Potent and Selective FLT3 Inhibitor to Date

Retrieved on: 
Monday, December 12, 2022
Society, Osteopathic medicine in Canada, RTK, FDA, Cancer, ASH, FLT3, U.S. Postal Service Pro Cycling Team, AML, Survival, Research, Human, IND, Standard of care, Mutation, Risk, Patient, Therapy, Pharmaceutical industry

“The majority of late-stage and approved FLT3 inhibitors fall short of providing sufficient and sustained inhibition of FLT3 signaling required for maximal benefit.

Key Points: 
  • “The majority of late-stage and approved FLT3 inhibitors fall short of providing sufficient and sustained inhibition of FLT3 signaling required for maximal benefit.
  • We believe that targeting FLT3 with a covalent inhibitor, as we did with menin, represents another significant opportunity to improve the outcomes that reversible inhibition provide.
  • Nearly 30% of AML patients have a FLT3 mutation, representing more than 6,000 incident patients in the United States each year.
  • Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Biomea Fusion to Participate in Piper Sandler 34th Annual Healthcare Conference

Retrieved on: 
Friday, November 11, 2022
Patient, Cancer, GLOBE, Conference, Pharmaceutical industry

REDWOOD CITY, Calif., Nov. 11, 2022 (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 Biomeas management will participate in a fireside chat and host investor meetings at the upcoming Piper Sandler 34th Annual Healthcare Conference.

Key Points: 
  • REDWOOD CITY, Calif., Nov. 11, 2022 (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 Biomeas management will participate in a fireside chat and host investor meetings at the upcoming Piper Sandler 34th Annual Healthcare Conference.
  • Biomea Fusion is 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.
  • The company is utilizing its proprietary FUSION System to advance a pipeline of covalent-binding therapeutic agents against key oncogenic drivers of cancer and metabolic diseases.
  • Biomea Fusions goal is to utilize its capabilities and platform to become a leader in developing covalent small molecules in order to maximize the clinical benefit when treating various cancers and metabolic diseases.

Biomea Fusion Reports Third Quarter 2022 Financial Results and Business Highlights

Retrieved on: 
Monday, November 7, 2022
IND, CTA, Research, Risk, Colorectal cancer, G&A, Diabetes, Securities Exchange Act of 1934, Company, Drug Quality and Security Act, Administration, IMS, Multiple myeloma, Annual general meeting, CLL, Society, Chronic lymphocytic leukemia, FLT3, Board, Health Canada, Securities Act of 1933, SEC, U.S. Securities and Exchange Commission, Cancer, CRC, Patient, NSCLC, LA, European Association for the Study of Diabetes, Mutation, Research and development, Commonwealth Fusion Systems, PDAC, Nasdaq, Association, R, EASD, Hematology, FDA, GLOBE, Infrared spectroscopy correlation table, Menin, Investment, KRAS, DLBCL, MM, File, Large-cell lung carcinoma, CA, NPM1, MLL, Pharmaceutical industry, Medical imaging, Fine chemical

We also continue to advance our second IND candidate, BMF-500, an investigational covalent FLT3 inhibitor with best-in-class potential, toward the clinic.

Key Points: 
  • We also continue to advance our second IND candidate, BMF-500, an investigational covalent FLT3 inhibitor with best-in-class potential, toward the clinic.
  • BMF-500 further demonstrates the versatility enabled by our proprietary FUSION System to discover and validate novel covalent product candidates.
  • Biomea Fusion is a biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases.
  • Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Biomea Fusion to Present Preclinical Data for BMF-500, an Investigational Oral Covalent FLT3 Inhibitor, at the 64th American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Thursday, November 3, 2022
Securities Exchange Act of 1934, Research, CD135, Overalls, GLOBE, Gene family, FDA, Cell, Ernest, IND, FLT3, Mutation, ASH, Acute myeloid leukemia, Standard of care, Nasdaq, FMS, Transplant, Phosphorylation, TKD, Securities Act of 1933, U.S. Securities and Exchange Commission, Cysteine, Cancer, Drug Quality and Security Act, Risk, PD, Osteopathic medicine in Canada, AML, SEC, Survival, Patient, Cellular, Pharmaceutical industry, Vaccine

We believe the preclinical data we will present at ASH has the potential to establish BMF-500 as the most potent and selective FLT3 inhibitor reported to date.

Key Points: 
  • We believe the preclinical data we will present at ASH has the potential to establish BMF-500 as the most potent and selective FLT3 inhibitor reported to date.
  • The potent covalent inhibition of FLT3 by BMF-500 manifested in effective and durable cellular response that was improved over gilteritinib.
  • In cells harboring FLT3 activating mutations, BMF-500 induced dose-dependent inhibition of FLT3 phosphorylation and downstream signaling, including phospho-STAT5 and phospho-ERK.
  • Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Biomea Fusion Announces Dosing of First Patient with Type 2 Diabetes and Completion of Phase I Healthy Volunteer Portion of Phase I/II (COVALENT-111) Study of BMF-219

Retrieved on: 
Monday, October 31, 2022
Board, Safety, Natural history, Drug Quality and Security Act, PD, Securities Act of 1933, Securities Exchange Act of 1934, Insulin, Research, Cancer, Association, Degenerative disease, U.S. Securities and Exchange Commission, Patient, SEC, Pancreas, Health Canada, CTA, Type 2 diabetes, Risk, Securities and Exchange Commission (Philippines), Adult, Phase, Microdeletion syndrome, Disease, GLOBE, PK, Doctor of Philosophy, Growth, FDA, IND, Harvard Medical School, Hyperglycemia, European Association for the Study of Diabetes, Regeneration, Nasdaq, Pharmacokinetics, Pharmaceutical industry, Diabetes

Biomea has completed the Phase I portion of the trial in healthy volunteers.

Key Points: 
  • Biomea has completed the Phase I portion of the trial in healthy volunteers.
  • With the dosing of our first patient with BMF-219, we have reached an important milestone for the nearly 500 million patients worldwide with type 2 diabetes.
  • With the completion of the Phase I portion in healthy volunteers, we have now swiftly progressed to dosing type 2 diabetes patients in the Phase II.
  • Phase II consists of multiple ascending dose cohorts and includes adult patients with type 2 diabetes uncontrolled by current therapies.

Biomea Fusion Announces First Patient Dosed with Chronic Lymphocytic Leukemia (CLL) in COVALENT-101 Trial

Retrieved on: 
Thursday, October 27, 2022
Survival, Diabetes, U.S. Securities and Exchange Commission, SEC, Securities Exchange Act of 1934, NPM1, MM, Safety, Cancer, Chronic leukemia, DLBCL, TP53, Risk, CLL, NOTCH1, Patient, Osteopathic medicine in Canada, Board, Multiple myeloma, ALL, ASCO, Research, Rai, GLOBE, B-cell lymphoma, Securities Act of 1933, Lists of diseases, Drug Quality and Security Act, Institutional review board, Chromosome, Vaccine, Pharmaceutical industry

Additional information about the Phase I clinical trial of BMF-219 can be found at ClinicalTrials.gov using the identifier NCT05153330.

Key Points: 
  • Additional information about the Phase I clinical trial of BMF-219 can be found at ClinicalTrials.gov using the identifier NCT05153330.
  • CLL is a chronic leukemia that progresses relatively slowly and typically impacts older adults.
  • Biomea Fusion is 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.
  • Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

BMF-219 Enters the Clinic for KRAS Solid Tumors

Retrieved on: 
Friday, October 14, 2022
U.S. Securities and Exchange Commission, Colon, Pancreatic cancer, PDAC, Drug Quality and Security Act, Risk, SEC, Securities Exchange Act of 1934, IND, Lists of diseases, SEER, Patient, Research, Investigational New Drug, Securities Act of 1933, CRC, Cancer, RAS, Nasdaq, Colorectal cancer, KRAS, Oncogene, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Lung cancer, Mutation, Rectum, Phosphorylation, TEAM, Osteopathic medicine in Canada, Board, Incidence, Safety, Prognosis, Diabetes, Survival, GLOBE, NCI, FDA, Consultant, Fusion, Pharmaceutical industry, Medical imaging, Vaccine, NSCLC

Biomea Fusion announces FDA clearance of Investigational New Drug (IND) application for covalent menin inhibitor BMF-219 in KRAS solid tumors.

Key Points: 
  • Biomea Fusion announces FDA clearance of Investigational New Drug (IND) application for covalent menin inhibitor BMF-219 in KRAS solid tumors.
  • BMF-219 is the first menin inhibitor to enter clinical trials for the treatment of solid tumors.
  • KRAS is the most frequently mutated isoform amongst RAS oncogenes in human solid tumors, with high prevalence in NSCLC, CRC, and pancreatic cancer.
  • With only one approved therapy targeting KRAS G12C for locally advanced or metastatic NSCLC, KRAS-driven tumors continue to represent a significant unmet medical need.