Biomea Fusion Touts Additional Preclinical Data For Blood Cancer Candidate

  • Biomea Fusion Inc BMEA announced the presentation of two posters at the 19th International Myeloma Society (IMS) Annual Meeting. 
  • The first presentation covered preclinical data from BMF-219 in high-grade B-cell lymphoma and multiple myeloma. 
  • BMF-219 exhibits multi-fold higher potency and complete growth inhibition in these preclinical models than clinical reversible menin inhibitors, demonstrating its unique antitumor potential in TP53, KRAS, and NRAS mutated cancers.
  • Related: Biomea Fusion Shares BMF-219 Preclinical Data At AACR 2022 Meeting.
  • The second presentation detailed a Phase 1 study of BMF-219 in patients with relapsed/refractory acute leukemia, diffuse large B-cell lymphoma, and multiple myeloma.
  • Doses of BMF-219 will be escalated in single-subject cohorts independently for each indication until one subject experiences a ≥ Grade 2 related adverse event or dose-limiting toxicity (DLT). 
  • The primary objective is to determine independently for each cohort/indication the optimal biological dose/ recommended Phase 2 dose (RP2D) of BMF-219 oral monotherapy. 
  • Key secondary objectives include further evaluation of safety and tolerability, antitumor activity based on best overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and time to progression.
  • Enrollment in COVALENT-101 commenced in January 2022.
  • Price Action: BMEA shares are down 1.28% at $12.35 on the last check Friday.
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