- 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
“We are honored and deeply humbled by this significant milestone, which marks our successful transition to a clinical stage company. Just over four years ago, we took the concept of designing a small molecule that targets menin and brought forward BMF-219 to the clinic to significantly improve the lives of patients,” said
“Since 2017, we have focused on building a world-class discovery and development team at
The current Phase I, open-label, multi-center, dose escalation and dose expansion study is designed to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics of once daily oral dosing of BMF-219 in patients with r/r acute leukemias, including subpopulations where menin inhibition is expected to provide a therapeutic benefit (e.g., patients with MLL1/KMT2A gene rearrangements or NPM1 mutations). Additional information about the Phase I trial of BMF-219 can be found at ClinicalTrials.gov using the identifier NCT05153330.
Acute Myeloid Leukemia (AML) and Acute Lymphocytic Leukemia (ALL)
AML is the most common form of acute leukemia in adults and is responsible for the largest number of annual leukemia deaths in the
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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 the number of clinical sites expected to be involved in the ongoing Phase I clinical trial of BMF-219 and the anticipated scope of the trial, our plans to prepare for and initiate additional clinical trials of BMF-219 in other types of cancer and in diabetes, our plans to announce our next pipeline candidate, 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.
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Director, Investor Relations & Corporate Development
vsandwick@biomeafusion.com
(650) 460-7759
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