Be Bio Secures $82 Million Funding

Be Bio Secures $82 Million Funding

Be Biopharma, a Cambridge-based biotech company, has taken a major step forward with its cutting-edge treatments for Hemophilia B and Hypophosphatasia, following an $82 million round of financing.

This significant capital injection will fuel the company’s efforts to push its lead program, BE-101, into clinical trials, while advancing its second therapy candidate, BE-102.

Backed by key venture capital firms and pharmaceutical giants, Be Bio's transition into a clinical-stage company signals a pivotal moment for its mission to revolutionize genetic medicine.

The new funding, led by ARCH Venture Partners, Atlas Venture, RA Capital, Alta Partners, Longwood Fund, Bristol Myers Squibb, and Takeda Ventures, will propel BE-101 through clinical proof-of-concept trials. BE-101, a groundbreaking B Cell Medicine (BCM) designed for Hemophilia B, received FDA clearance earlier this year and is now enrolling patients in a Phase 1/2 trial.

Notably, the U.S. Food and Drug Administration has granted BE-101 Fast Track Designation, a recognition that could potentially expedite the drug’s development and review process.

“Advancing two BCMs that harness the potential of this new modality represents an exciting step in transforming the treatment landscape for their respective indications,” said Joanne Smith-Farrell, Ph.D., Be Bio’s Chief Executive Officer.

With BE-101, Be Bio is pioneering an approach that could reshape the future of Hemophilia B care, providing a durable, titratable, and redosable therapy that doesn’t require preconditioning—a game-changer for the roughly 40,000 people worldwide affected by the condition.

Hemophilia B, caused by mutations in the gene responsible for producing Factor IX (FIX), leads to excessive bleeding. Current therapies involve frequent FIX replacement therapy, requiring weekly or bi-weekly infusions. BE-101 aims to simplify this by offering sustained therapeutic levels of FIX through a single infusion, reducing the frequency of treatments and potentially cutting down on bleeding episodes.

Simultaneously, Be Bio has nominated its second development candidate, BE-102, to address Hypophosphatasia (HPP), a rare genetic disorder that affects around 50,000 people. HPP results from ALPL gene mutations, causing severe deficiencies in alkaline phosphatase (ALP), essential for bone and dental health.

“We’re eager to advance BE-102 to address the needs of a large patient population with few to no therapeutic options,” added Dr. Smith-Farrell.

Early data presented at the 2024 American Society for Bone and Mineral Research meeting show BE-102’s potential to deliver long-lasting ALP production, offering hope for a more effective treatment than the current therapy, which requires multiple weekly injections.

The company’s rise is not just driven by scientific breakthroughs but also by bolstering its leadership. Be Bio recently welcomed Suha Patel as Senior Vice President of Commercial & Franchise Strategy and Kiran Patki, MD as Senior Vice President of Clinical Development. Patel, a former Roche/Genentech executive, led the successful launch of Hemlibra, while Patki brings a wealth of experience from his tenure at Rally Bio and Alexion Pharmaceuticals.

  • “We are delighted to welcome Suha and Kiran,” said Dr. Smith-Farrell, highlighting their vital roles as Be Bio pivots toward full-scale product development.

As the company sets its sights on advancing BE-101 and BE-102, Be Bio’s innovative approach to engineered B cells offers a glimpse into the future of cellular medicine.

With strong investor support, strategic leadership hires, and promising early results, Be Bio is positioning itself as a leader in the genetic medicine space, aiming to make a lasting impact on the lives of patients with rare genetic disorders.