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Biomea Fusion Announces Appointment of Steve Morris, M.D. as Chief Medical Officer

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Biomea Fusion has appointed Dr. Steve Morris as Chief Medical Officer, who previously served as a consultant since 2020. He will lead the clinical development of BMF-219, an irreversible covalent menin inhibitor currently in a Phase I trial aimed at treating patients with specific acute leukemias. Biomea plans to expand clinical studies for BMF-219 into seven tumor types and diabetes. Dr. Morris' extensive research background includes significant contributions to the understanding of oncogenes like ALK, enhancing the company's clinical prospects in oncology.

Positive
  • Appointment of Dr. Steve Morris as CMO brings recognized expertise to lead BMF-219's clinical development.
  • BMF-219 is advancing into clinical trials targeting up to seven distinct tumor types, signaling growth potential.
Negative
  • There is a potential risk related to delays in patient enrollment and clinical trial execution.
  • Renowned physician-scientist’s groundbreaking work led to the discovery and characterization of multiple oncogenes, including anaplastic lymphoma kinase (ALK)
  • Dr. Morris will lead clinical development of BMF-219, an irreversible covalent menin inhibitor currently in a Phase I clinical trial, and additional planned clinical programs
  • Company plans to initiate clinical development of BMF-219 in up to seven distinct tumor types, as well as diabetes, in 2022

REDWOOD CITY, Calif., Feb. 01, 2022 (GLOBE NEWSWIRE) -- 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 the appointment of Steve Morris, M.D. as Chief Medical Officer (CMO). Dr. Morris, who has been serving as a clinical consultant to Biomea since 2020, will now lead the clinical development of BMF-219, an irreversible covalent menin inhibitor, as well as the company’s additional planned clinical programs. BMF-219 is currently in a Phase I clinical trial for the treatment of patients with relapsed/refractory acute leukemias, including those with MLL1/KMT2A gene rearrangements or NPM1 mutations. In January 2022, Biomea announced that it plans to initiate clinical studies of BMF-219 in up to seven liquid and solid tumor types –acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL), multiple myeloma (MM), diffuse large B-cell lymphoma (DLBCL), non-small cell lung cancer (NSCLC), pancreatic cancer, and colorectal cancer– as well as diabetes.

“I am thrilled with Steve’s decision to join Biomea full-time as the company’s first CMO,” said Thomas Butler, Biomea’s CEO and Chairman of the Board. “Steve is an internationally recognized physician-scientist and translational investigator with over 30 years of clinical and academic research expertise. Through his first-hand experience interrogating the role that menin plays in aggressive cancers both as a researcher and as a practicing oncologist, Steve has a unique perspective on how BMF-219 may benefit patients suffering from genetically driven liquid and solid tumors. He played a critical role in orchestrating our rapid advancement of BMF-219 into the clinic, and we look forward to his continued contributions in this new capacity as our CMO.”

Prior to embarking on a career in the biopharmaceutical industry in 2012, Dr. Morris served on the staff at St. Jude Children’s Research Hospital for 25 years. In addition to working as a clinician, he led a basic and translational research laboratory at St. Jude, which discovered and characterized oncogenes that cause a variety of human cancers, most notably anaplastic lymphoma kinase, or ALK. The U.S. Food and Drug Administration (FDA) has approved several ALK inhibitors, the development of which were based on Dr. Morris’ groundbreaking work. Dr. Morris also performed translational research at St. Jude regarding menin-driven leukemias (one of several menin-driven oncology indications being pursued by Biomea) and treated many patients with these malignancies during his career as a practicing oncologist.

“I am excited to continue the extraordinary work we have done at Biomea over the last two years translating the promise of Biomea’s Fusion platform, which allows the rapid targeting of validated cancer biology with breakthrough covalent chemistry, to advance the company’s first clinical-stage irreversible covalent inhibitor, BMF-219,” said Dr. Morris. “With the potential to dose patients in up to seven distinct tumor types with BMF-219 in the coming months, 2022 will be a transformational year for Biomea. I look forward to continuing to execute on the robust clinical development plan we announced to further our collective goal of providing effective targeted treatments for patients with limited therapeutic options.”

Since leaving academic medicine, Dr. Morris has served as a consultant or CMO for multiple oncology-focused biotech startups, including Biomea. He is a member of the medical honor society Alpha Omega Alpha, an American Society of Clinical Oncology Young Investigator Award winner, and an inductee into the American Society for Clinical Investigation. Dr. Morris earned his MD from Louisiana State University Health Science Center, completed an internal medicine residency at the University of Texas Southwestern Health Science Center, and completed training in medical oncology at Yale University School of Medicine.

About Biomea Fusion

Biomea Fusion is a biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers and metabolic diseases. An irreversible small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional reversible drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response. The company is utilizing its proprietary FUSION™ System to advance a pipeline of irreversible-binding therapeutic agents against key oncogenic drivers of cancer and metabolic diseases. Biomea Fusion’s goal is to utilize its capabilities and platform to become a leader in developing irreversible small molecules in order to maximize the clinical benefit when treating various cancers and metabolic diseases.

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, the potential of BMF-219 as a treatment for various types of cancer and diabetes, our research, development and regulatory plans, including our plans to initiate clinical development of BMF-219 in up to seven distinct tumor types, as well as 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 patient enrollment and in the initiation, conduct and completion of our planned clinical trials. These risks concerning Biomea Fusion’s business and operations are described in additional detail in its periodic filings with the SEC, including its most recent period 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.

Contact:

Van Sandwick
Director, Investor Relations & Corporate Development
vsandwick@biomeafusion.com
(650) 460-7759


FAQ

Who is the new Chief Medical Officer of Biomea Fusion?

Dr. Steve Morris has been appointed as the Chief Medical Officer of Biomea Fusion.

What is BMF-219 and what clinical trials are planned?

BMF-219 is an irreversible covalent menin inhibitor currently in Phase I trials, with plans to expand studies into seven tumor types and diabetes.

What was Dr. Morris's role prior to becoming CMO?

Dr. Morris served as a clinical consultant for Biomea since 2020 before being appointed CMO.

What are the expected outcomes of the clinical trials for BMF-219?

The trials aim to assess BMF-219's effectiveness in treating genetically defined cancers and diabetes.

Biomea Fusion, Inc.

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