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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為候選血癌患者兜售更多臨牀前數據
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.納斯達克(Sequoia Capital：BMEA)宣佈在第19屆國際骨髓瘤協會(IMS)年會上發佈了兩張海報。
  • 第一個報告涵蓋了來自BMF-219的高級別B細胞淋巴瘤和多發性骨髓瘤的臨牀前數據。
  • 在這些臨牀前模型中，BMF-219顯示出比臨牀可逆薄荷素抑制劑高出數倍的效力和完全的生長抑制，顯示出其在TP53、KRAS和NRAS突變癌症中的獨特抗腫瘤潛力。
  • 相關： Biomea Fusion在AACR 2022會議上分享BMF-219臨牀前數據.
  • 第二個報告詳細介紹了BMF-219在復發/難治性急性白血病、瀰漫性大B細胞淋巴瘤和多發性骨髓瘤患者中的第一階段研究。
  • Bmf-219的劑量將在每個適應症的單一受試者隊列中獨立增加，直到一個受試者經歷與≥2級相關的不良事件或劑量限制毒性(DLT)。
  • 主要目標是為每個隊列/適應症獨立確定BMF-219口服單一療法的最佳生物劑量/推薦的第二階段劑量(RP2D)。
  • 關鍵的次要目標包括進一步評估安全性和耐受性、基於最佳總應答率(ORR)、反應持續時間(DOR)、無進展生存期(PFS)和進展時間的抗腫瘤活性。
  • 共價101的註冊於2022年1月開始。
  • 價格行動：在上週五的最後一次檢查中，BMEA股價下跌1.28%，至12.35美元。
声明：本內容僅用作提供資訊及教育之目的，不構成對任何特定投資或投資策略的推薦或認可。 更多信息
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