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Biomea Fusion Touts Additional Preclinical Data For Blood Cancer Candidate

Biomea Fusion Touts Additional Preclinical Data For Blood Cancer Candidate

Biomea Fusion为候选血癌患者兜售更多临床前数据
Benzinga Real-time News ·  2022/08/26 13:14
  • Biomea Fusion Inc (NASDAQ: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.
  • Biomea Fusion Inc.纳斯达克(Sequoia Capital：BMEA)宣布在第19届国际骨髓瘤协会(IMS)年会上发布了两张海报。
  • 第一个报告涵盖了来自BMF-219的高级别B细胞淋巴瘤和多发性骨髓瘤的临床前数据。
  • 在这些临床前模型中，BMF-219显示出比临床可逆薄荷素抑制剂高出数倍的效力和完全的生长抑制，显示出其在TP53、KRAS和NRAS突变癌症中的独特抗肿瘤潜力。
  • 相关： Biomea Fusion在AACR 2022会议上分享BMF-219临床前数据.
  • 第二个报告详细介绍了BMF-219在复发/难治性急性白血病、弥漫性大B细胞淋巴瘤和多发性骨髓瘤患者中的第一阶段研究。
  • Bmf-219的剂量将在每个适应症的单一受试者队列中独立增加，直到一个受试者经历与≥2级相关的不良事件或剂量限制毒性(DLT)。
  • 主要目标是为每个队列/适应症独立确定BMF-219口服单一疗法的最佳生物剂量/推荐的第二阶段剂量(RP2D)。
  • 关键的次要目标包括进一步评估安全性和耐受性、基于最佳总应答率(ORR)、反应持续时间(DOR)、无进展生存期(PFS)和进展时间的抗肿瘤活性。
  • 共价101的注册于2022年1月开始。
  • 价格行动：在上周五的最后一次检查中，BMEA股价下跌1.28%，至12.35美元。
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