On November 5, 2024 Be Biopharma, Inc. ("Be Bio"), a company pioneering the development of engineered B Cell Medicines (BCMs), reported that an abstract relating to its BCM platform has been accepted for oral presentation at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held in San Diego, California from December 7 to 10, 2024 (Press release, Be Biopharma, NOV 5, 2024, View Source [SID1234647765]). In addition, a Trials in Progress abstract related to the BeCoMe-9 Phase 1/2 clinical trial for BE-101 in hemophilia B has been accepted for online publication. Both abstracts were published today and are now available on the ASH (Free ASH Whitepaper) website at www.hematology.org.
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Details regarding the Be Biopharma oral presentation are as follows:
Abstract Title: A Versatile B Cell Engineering Platform Enables Development of B Cell Medicines for Sustained Delivery of Therapeutic Biologics (Abstract #88)
Session Name: 703. Cellular Immunotherapies other than CAR-T Cells: Basic and Translational: Novel Cell Platforms and Delivery Strategies
Date: Saturday, December 7, 2024
Presentation Time: 10:15 a.m. PT
Session Room: San Diego Convention Center, Ballroom 20AB
Details regarding the Be Biopharma online abstract are as follows:
Abstract Title: 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 (Abstract #5479)
About Engineered B Cell Medicines – A New Class of Cellular Medicines
The B cell is a powerful cell that produces thousands of proteins per cell per second at constant levels, over decades. Precision genome editing can now be used to engineer B Cells that produce therapeutic proteins of interest, driving a new class of cellular medicines – Engineered B Cell Medicines (BCMs) – with the potential to be durable, allogeneic, redosable, titratable and administered without pre-conditioning. The promise of BCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.
About BE-101
BE-101 is a first-in-class BCM that is engineered to insert the human Factor IX (FIX) gene into primary human B cells, allowing for continuous expression of active FIX for the treatment of hemophilia B. BE-101 has the potential to express sustained therapeutic FIX activity levels with a single infusion while having the flexibility to be titrated and/or re-dosed, and without the need for preconditioning. The potential to maintain therapeutic FIX activity levels while the reducing dosing frequency associated with current FIX replacement regimens could address the considerable infusion burden associated with current therapies and potentially drive reductions in the annualized bleeding rates and FIX usage. The US FDA cleared the BE-101 IND in May of 2024, and granted Fast Track designation in September of 2024. The Phase 1/2 BeCoMe-9 Trial is open for enrollment and further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06611436.