Biomea Fusion Announces First Patient Dosed with Chronic Lymphocytic Leukemia (CLL) in COVALENT-101 Trial

• COVALENT-101 now includes patients with relapsed/refractory (R/R) CLL
• BMF-219 is the first menin inhibitor in the clinic for CLL
• Preclinical data presented at ASCO 2022 demonstrated the potency of BMF-219, a covalent menin inhibitor, across varying cytogenetic risk profiles and Rai stages, indicating broad activity with over 98% cell lethality in these CLL models at clinically achievable concentrations
• R/R CLL patient population represents an area of high unmet need

Excerpt from the Press Release:

REDWOOD CITY, Calif., Oct. 27, 2022 (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 dosing of the first patient in the CLL cohort of COVALENT-101, the company’s ongoing Phase I clinical trial evaluating BMF-219, Biomea’s investigational covalent menin inhibitor, in patients with R/R AML, ALL, DLBCL, MM, and now CLL.

“Despite the advances in the treatment of CLL, we know that the majority of patients relapse and are in need of a new, novel therapy,” stated Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board. “Based on the remarkable preclinical data we presented at ASCO of BMF-219’s effect in CLL models, including comparisons to currently available treatments, we believe BMF-219 could represent a transformative treatment option for CLL patients. With many of the Biomea Fusion team members having a long history and involvement with the successful development of CLL agents, and ibrutinib in particular, it’s quite special to be able to now evaluate the clinical potential of BMF-219 for those CLL patients that are still in need of a therapy.”

At ASCO, Biomea presented data demonstrating BMF-219’s powerful cell-killing activity as a novel, first-in-class single agent against CLL patient samples, representing a broad spectrum of mutational profiles, including those with poor prognostic mutations, such as TP53 and NOTCH1, chromosomal aberrations such as del(13q), trisomy 12 and complex karyotype. BMF-219 demonstrated near 100% response even in samples resistant to multiple standard-of-care agents.

Click the button below to read the entire Press Release:

Continue Reading The Press Release