Highlights From the 66th ASH Annual Meeting and Exposition
BeCoMe–9: A Phase 1/2 Dose Escalation and Expansion Study of be-101 for the Treatment of Adults With Moderately Severe or Severe Hemophilia B
Presenting Author: Steven W. Pipe, MD
Steven W. Pipe, MD1, Mark T. Reding, MD2, Bryan Chin3*, Karen Campbell3*, Hanlan Liu, PhD3*, and Wing Yen Wong, MD3
- University of Michigan, Ann Arbor, MI
- Center for Bleeding and Clotting Disorders, University of Minnesota Medical Center, Minneapolis, MN
- Be Biopharma, Cambridge, MA
Data Points
Figure 1: Mechanism of Action
BE-101 is a first-in class B cell medicine composed of expanded and differentiated B lymphocyte cells genetically engineered to express FIX. The BeCoMe-9 Study is a first-in-human, multi-center, open-label study evaluating the safety and efficacy of a single intravenous dose of BE-101 in adults with moderately severe or severe Hemophilia B (< 2 IU/dL FIX). BE-101 is designed to engraft in patients and secrete FIX into circulation to restore functional FIX levels. Up to 24 participants will be enrolled (18 in Part 1 and 6 in Part 2a). Participants will undergo screening, leukapheresis for manufacturing, and monitoring for one-year post-administration. Enrollment of the first cohort is expected to begin in late 2024.
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