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 24th at 5:30 pm PT
Biomea to hold conference call and webcast on Monday, June 26th at 5:30 am PT
REDWOOD CITY, Calif., June 20, 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 present new clinical data from the ongoing Phase II portion of its COVALENT-111 trial, which is evaluating BMF-219 as a potential treatment for patients with type 2 diabetes, in a late-breaking poster presentation at the 2023 American Diabetes Association’s (ADA’s) 83rd Scientific Sessions, to be held June 23 – 26, 2023 at the San Diego Convention Center in San Diego, CA. The company will also host an in-person KOL investor event during the meeting.
Biomea ADA 2023 Late-Breaking Poster-Presentation
Title: COVALENT-111, a Phase 1/2 Trial of BMF-219, a Covalent Menin Inhibitor, in Patients with Type 2 Diabetes Mellitus—Preliminary Results
Poster Presentation Number: 91-LB
Category: 12-D Clinical Therapeutics—Other Therapeutic Agents
Display Time: June 23rd at 6:30 pm – June 26th at 2:00 pm PT
Presentation Time: Saturday, June 24th from 11:30 am – 12:30 pm PT
Embargo: Poster presentation with updated abstract clinical data remains embargoed until Friday, June 23rd at 6:30 pm PT
The loss of insulin-producing beta cells is a root biological cause of type 2 diabetes and its progression. BMF-219, a novel covalent menin inhibitor, is designed to potentially regenerate, preserve, and reactivate healthy, insulin-producing beta cells, thereby normalizing glycemic control and halting or reversing type 2 diabetes disease progression. Biomea is evaluating BMF-219’s potentially novel mechanism of action with an intended treatment goal of re-establishing a pool of healthy beta cells, which may allow for continued glycemic control for prolonged periods even after treatment is stopped.
Details for Biomea’s ADA 2023 Investor Events
In-Person KOL Event – Saturday, June 24th at 5:30 pm PT
This event will be held at Aqua ABC (located on the 3rd level of Hilton Bayfront Hotel – 1 Park Blvd, San Diego, CA 92101). Featured speakers include:
Juan Pablo Frías, M.D.
Medical Director and Principal Investigator at Velocity Clinical Research, former Clinical Assistant Professor of Medicine, Division of Endocrinology at the University of California, San Diego School of Medicine and former CMO and SVP Clinical and Medical Affairs, Diabetes Care at Johnson & Johnson; Member of Biomea’s Scientific Advisory Board
Rohit Kulkarni, M.D., Ph.D.
Senior Investigator and Professor of Medicine at Harvard Medical School, and Faculty Member of the Joslin Diabetes Center; Member of Biomea’s Scientific Advisory Board,
Jose E. Rodriguez, M.D.
Internal Medicine & Medical Director at the Southwest General Healthcare Center (Fort Myers, Florida), and an investigator in Biomea’s COVALENT-111 clinical trial.
Conference Call and Webcast – Monday, June 26th at 5:30 am PT (8:30 am ET)
The webcast and related presentation will be available to registered attendees under the Investors and Media section of Biomea’s website at https://investors.biomeafusion.com/news-events/events.
A replay of the presentation will be archived on Biomea’s website following the event.
Participants who wish to join the call and ask a question may register here to receive the dial-in numbers and unique PIN to seamlessly access the call. Otherwise please access the listen-only webcast available on Biomea’s website.
COVALENT-111
COVALENT-111 is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study. In the completed Phase I portion of the trial, healthy volunteers were enrolled in single ascending dose cohorts to evaluate safety at the prospective dosing levels for patients with type 2 diabetes. Phase II consists of multiple ascending dose cohorts and includes adult patients with type 2 diabetes uncontrolled by current therapies. Additional information about the Phase I/II clinical trial of BMF-219 in type 2 diabetes can be found at ClinicalTrials.gov using the identifier NCT05731544.
In March 2023, Biomea announced initial topline clinical data for the first two cohorts of patients with type 2 diabetes enrolled in the Phase II portion of the trial. A link to the press release can be found here and a link to webcast can be found here.
About Menin’s Role in Diabetes
Loss of functional beta cell mass is a core component of the natural history in both types of diabetes — type 1 diabetes (mediated by autoimmune dysfunction) and type 2 diabetes (mediated by metabolic dysfunction). Beta cells are found in the pancreas and are responsible for the synthesis and secretion of insulin. Insulin is a hormone that helps the body use glucose for energy and helps control blood glucose levels. In patients with diabetes, beta cell mass and function have been observed to be diminished, leading to insufficient insulin secretion and hyperglycemia. Menin is thought to act as a brake on beta-cell turnover and growth, supporting the notion that inhibition of menin could lead to the regeneration of normal, healthy beta cells. Based on these and other scientific findings, Biomea is exploring the potential for BMF-219-mediated menin inhibition as a viable therapeutic approach to potentially halt or reverse progression of type 2 diabetes.
