Be Biopharma to Present at 66th ASH Annual Meeting

Be Biopharma, Inc. (Be Bio), a leader in the development of engineered B Cell Medicines (BCMs), announced the acceptance of an abstract related to its BCM platform for an oral presentation at the forthcoming 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The event will take place in San Diego, California from December 7 to 10, 2024. An additional abstract, concerning the BeCoMe-9 Phase 1/2 clinical trial for BE-101 in hemophilia B, has also been accepted for online publication. Both abstracts are now accessible on the ASH website.

The oral presentation by Be Biopharma will focus on a versatile B cell engineering platform that facilitates the development of B Cell Medicines for the sustained delivery of therapeutic biologics. This session is scheduled for Saturday, December 7, 2024, at 10:15 a.m. PT in Ballroom 20AB of the San Diego Convention Center.

The second abstract discusses the BeCoMe-9 study, a Phase 1/2 dose escalation and expansion trial of BE-101. This study aims to assess the treatment's safety and efficacy in adults with moderately severe or severe hemophilia B.

Engineered B Cell Medicines (BCMs) represent a novel category of cellular medicines. B cells are capable of producing thousands of proteins per second at consistent levels for decades. With advancements in precision genome editing, B cells can now be engineered to produce specific therapeutic proteins, heralding a new era of BCMs. These medicines are designed to be durable, allogeneic, redosable, and titratable, and they can be administered without prior conditioning. The potential of BCMs lies in their ability to transform therapeutic biologics, offering extensive applications across various protein classes, patient groups, and therapeutic areas.

BE-101 stands out as a first-in-class BCM, engineered to incorporate the human Factor IX (FIX) gene into primary human B cells. This engineering allows for the continuous expression of active FIX, targeting the treatment of hemophilia B. BE-101 offers the potential for sustained therapeutic FIX activity levels with just one infusion. Additionally, it allows for flexible titration or re-dosing without the need for preconditioning. By maintaining therapeutic FIX activity levels and reducing the dosing frequency compared to current FIX replacement therapies, BE-101 could ease the significant infusion burden associated with existing treatments. This reduction in infusion frequency may also lead to lower annualized bleeding rates and decreased FIX usage.

The U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for BE-101 in May 2024, and the treatment received Fast Track designation in September 2024. The Phase 1/2 BeCoMe-9 clinical trial is currently open for enrollment, with further details available on the ClinicalTrials.gov website under the identifier NCT06611436.

Be Biopharma, founded in October 2020, is committed to pioneering BCMs to significantly enhance the lives of patients suffering from genetic diseases, cancer, hemophilia B, and other serious conditions. The company is supported by notable investors and partners, including ARCH Venture Partners, Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund, Bristol Myers Squibb, Takeda Ventures, and Seattle Children’s Research Institute. The collaborative efforts of Be Bio's team aim to reshape the landscape of medicine through the innovative use of engineered B cells.