Be Biopharma has announced the closing of a $92 million Series C financing round, which will propel the clinical development of its B cell medicines (BCMs) BE-101 for hemophilia B and BE-102 for hypophosphatasia (HPP). The financing round saw participation from new investor Nextech, alongside existing investors including ARCH Venture Partners, Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund, Bristol Myers Squibb, and Takeda Ventures.
Advancing Clinical Programs
The proceeds from the Series C financing will be used to generate clinical proof-of-concept for BE-101 in the ongoing BeCoMe-9 Phase 1/2 clinical trial (NCT06611436) for individuals with hemophilia B. Additionally, the funding will support the advancement of BE-102 into clinical testing for the treatment of hypophosphatasia. Both programs are built on Be Bio’s BCM product platform, which aims to create durable, titratable, and redosable therapeutics without the need for preconditioning, producing sustained and constant levels of therapeutic proteins.
BE-101 for Hemophilia B
BE-101 is a first-in-class BCM 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. The potential to maintain therapeutic FIX activity levels while reducing dosing frequency associated with current FIX replacement regimens could address the considerable infusion burden associated with current therapies and potentially drive reductions in annualized bleeding rates and FIX usage. The U.S. Food and Drug Administration (FDA) cleared the BE-101 IND in May 2024 and granted Fast Track designation in September 2024.
BE-102 for Hypophosphatasia
BE-102 is a first-in-class BCM engineered using artificial intelligence-guided protein design to modify primary human B cells to produce ALP, an enzyme deficient in people living with HPP. A single infusion of BE-102 has the potential to express sustained therapeutic ALP with the flexibility to be titrated and/or re-dosed, if needed, and without the need for pre-conditioning. BE-102 has been selected as a Development Candidate and has the potential to transform the standard of care for people living with HPP.
Leadership Perspective
"With this funding in hand, we are well-equipped to advance our two lead programs and solidify our position as a multi-program, clinical-stage company," said Joanne Smith-Farrell, Ph.D., Chief Executive Officer of Be Bio. "We are on track to demonstrate clinical proof-of-concept for BE-101 in Hemophilia B this year. Additionally, BE-102 is poised to enter the clinic next year, potentially demonstrating BCMs’ potential to become a new gold standard in enzyme replacement by providing hypophosphatasia patients with a transformative new option."
