- BMF-219 is the first menin inhibitor to be clinically studied in patients with KRAS-mutated non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC)
- A pan-KRAS inhibitor targeting multiple KRAS mutations (including G12C, G12D and G12R, among others) has the potential to treat 25-35% of NSCLC patients, 35-45% of CRC patients, and approximately 90% of PDAC patients
- BMF-219 is now in clinical development across eight liquid and solid tumor types, as well as for patients with type 2 diabetes
“We are eager to explore the potential of BMF-219 as a pan-KRAS inhibitor in patients with three of the most prominent KRAS-mutant solid tumor types, including those with tumors that have failed to respond to investigational and approved mutation-specific KRAS inhibitors,” said
KRAS is the most frequently mutated isoform amongst RAS oncogenes in human solid tumors, with high prevalence in NSCLC, CRC, and PDAC. KRAS G12C, KRAS G12D and KRAS G12V are among the most common KRAS mutations. However, there are numerous other known activating KRAS mutations. With only two approved therapies both targeting only KRAS G12C for locally advanced or metastatic NSCLC, KRAS-driven tumors continue to represent a significant unmet medical need.
As a covalent menin inhibitor, BMF-219 has manifested a differentiated profile over the commercially approved KRAS-targeted inhibitors LUMAKRAS (sotorasib) and KRAZATI (adagrasib) in multiple pre-clinical studies. As previously reported by Biomea, KRAS-mutant NSCLC, CRC, and PDAC cell lines and ex vivo patient specimens were highly sensitive to BMF-219 in preclinical models. The higher levels of activity of BMF-219 were observed among various KRAS-mutant solid tumor cell lines, but not KRAS wild type, suggesting that BMF-219 broadly inhibited mutant KRAS in these tumor models. A targeted pan-KRAS inhibitor has the potential to treat a large number of NSCLC, CRC, and PDAC patients.
About COVALENT–102
COVALENT-102 is an open-label, multi-cohort, multicenter, Phase I/Ib dose escalation and expansion study evaluating the safety, tolerability, and optimal biologic dose of BMF-219 administered orally to adult patients with KRAS-mutated unresectable, locally advanced or metastatic NSCLC, CRC, and PDAC. Additional information about the Phase I/Ib clinical trial of BMF-219 can be found at ClinicalTrials.gov using the identifier NCT05631574.
About Non-Small Cell
NSCLC is the most common form of lung cancer, representing approximately 82% of all lung cancer cases or approximately 200,000 cases in the
About Colorectal Cancer (CRC)
CRC is the fourth most common form of cancer and the second leading cause of cancer death in the
About Pancreatic Cancer (PDAC)
Pancreatic cancer is a relatively rare form of cancer in the
About
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 our cash runway, 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 pursuit of BMF-219 in KRAS-mutant solid tumors in our ongoing Phase I/Ib COVALENT-102 trial, the availability of clinical data for BMF-219 in oncology and 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.
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Contact:
SVP, Corporate Development
sb@biomeafusion.com
(650) 460-7759
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