• 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, 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 appointment of Juan Pablo Frías, M.D. as Chief Medical Officer (CMO). In his new role, Dr. Frías will leverage his deep industry and clinical investigator expertise in the development of therapeutics for the management of diabetes to oversee the clinical development of BMF-219, Biomea’s novel investigational menin inhibitor, for the treatment of type 2 and type 1 diabetes. Steve Morris, M.D., will transition to the new role of Chief Development Officer (CDO), where he will continue to lead clinical development of Biomea’s oncology portfolio, including BMF-219, BMF-500 and several early-stage oncology research candidates.

Dr. Frías is a board-certified endocrinologist who has served as principal investigator on over 250 clinical diabetes studies, with over half of those being Phase III studies, and has participated in the clinical development of more than 20 approved diabetic agents, including Mounjaro™ (tirzepatide’s SURPASS trials), Ozempic® (semaglutide’s STEP, SUSTAIN, and SUSTAIN FORTE trials), Trulicity® (dulaglutide’s AWARD trials), and Farxiga (dapagliflozin’s DURATION studies). Dr. Frías is a board member of the nonprofit T1D Exchange and a member of the clinical advisory boards to five of the top pharmaceutical companies in the diabetes care market. He has held leadership positions in Clinical and Medical Affairs at Eli Lilly, Amylin Pharmaceuticals, Pfizer, and Johnson & Johnson, where he served as CMO and Global Vice President of Clinical and Medical Affairs, Diabetes Care. Dr. Frías has also held academic positions at the University of Colorado Health Sciences Center, Barbara Davis Center for Diabetes, and the University of California San Diego School of Medicine, where he currently serves on the clinical faculty. He has published over 125 articles in peer reviewed journals; his numerous publications in this field include first author publications in the New England Journal of Medicine, Lancet, Lancet Diabetes and Endocrinology, Diabetes, Diabetes Care, and Cell Metabolism.

“The addition of Juan to the Biomea Leadership team is an important and exciting event for the company. Given the compelling data we have seen thus far from our ongoing Phase 1/2 trial of BMF-219 in type 2 diabetes, characterizing strong efficacy and safety in March and at American Diabetes Association Scientific Sessions this year, and as we accelerate toward initiating our first study of BMF-219 in type 1 diabetes, we are working to build up our in-house expertise in diabetes clinical development. Our appointment of Juan to lead clinical development of BMF-219 in diabetes is a cornerstone of this strategy,” said Thomas Butler, CEO and Chairman of Biomea. “As a scientific advisor to Biomea for the past year, Juan’s contributions have been invaluable, and we are very excited to now welcome him as a full-time member of our leadership team as Chief Medical Officer. We will look to his deep knowledge of patient needs as well as the expansive diabetes treatment landscape to help us fully define and maximize the potential benefits BMF-219 can bring to patients with type 2 and type 1 diabetes.”

Mr. Butler continued, “Concurrent to building our diabetes expertise, we will maintain our strong momentum advancing our robust oncology clinical development under the continued leadership of Steve Morris, as Chief Development Officer. Leveraging Steve’s and also now Juan’s medical and clinical development expertise in oncology and diabetes, respectively, enriches our potential to deliver breakthrough therapies, in parallel, for both of these therapeutic areas. The Biomea team continues to demonstrate strong execution of our clinical studies, which we now expect topline data of the escalation portion of COVALENT-111 in Q4; as well as additional data from COVALENT-101 in AML in Q4 of this year.”

Dr. Frías commented, “After working for the past two years with Biomea and their Scientific Advisory Board, to help execute the pre-clinical work validating the MOA and design the COVALENT-111 trial, I am excited to join Biomea Fusion full-time. The preclinical and clinical work has produced initial proof of concept data showing that BMF-219 can safely and robustly produce prolonged glycemic control through revitalization of beta cell health and function. Based on the data we’ve seen over the past six months from the ongoing COVALENT-111 study, I believe Biomea has an unparalleled opportunity with BMF-219 to address diabetes at a root-cause level with a first-in-class mechanism of action that has disease modifying potential. Enabling the proliferation of a patient’s own functional beta cells makes this molecule notably unique in the expansive diabetes treatment landscape of both approved and investigational drugs. Given Biomea is a new player in this space developing a new drug class for diabetes, I think we have a significant opportunity to educate investigators and potential partners and build understanding of the transformative potential of this disease-modifying treatment. I look forward to working with Tom and the entire Biomea team as we prepare to advance this important product candidate through critical upcoming clinical development milestones for both type 2 and type 1 diabetes.”

About Biomea Fusion

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. 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.

We are utilizing our proprietary FUSION™ System to discover, design and develop a pipeline of next-generation covalent-binding small molecule medicines designed to maximize clinical benefit for patients with various cancers and metabolic diseases, including diabetes. We aim to cure.

Visit us at www.biomeafusion.com and follow us on LinkedIn, Twitter and Facebook.

Forward-Looking Statements

Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding the clinical and therapeutic potential of our product candidates and development programs, including BMF-219 and BMF-500, the potential of BMF-500 as an FLT3 inhibitor and as a treatment for various types of cancers, the potential of BMF-219 as a treatment for various types of cancer and diabetes, our research, development and regulatory plans, the progress of our ongoing and planned clinical trials, including COVALENT-101, COVALENT-102, COVALENT-103 and our Phase I/II COVALENT-111 study of BMF-219 in type 2 diabetes, our plans to provide clinical updates on additional data from the initial dosing cohorts in COVALENT-111, our plans to provide future data from the Phase II portion of COVALENT-111, complete dose escalation, identify optimal dose levels, initiate dose expansion, our plans to explore longer duration of treatment and additional dosage forms and our plans to explore the potential utility of BMF-219 in type 1 diabetes, and the timing of such events, may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.

Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the risk that we may encounter delays in preclinical or clinical development, the preparation, filing and clearance of INDs, patient enrollment and in the initiation, conduct and completion of our ongoing and planned clinical trials and other research and development activities. These risks concerning Biomea Fusion’s business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission (the “SEC”), including its most recent periodic report filed with the SEC and subsequent filings thereafter. Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.