Pharma Focus Europe

Bit.bio Introduces Cell Therapy Pipeline, Highlighting Primary Candidate for Acute Liver Failure, and Expands Scientific Advisory Board with International Experts in Cell Therapy

Thursday, November 09, 2023

Bit.bio, an innovative company in the field of cell coding for novel cures, has disclosed its cell therapy pipeline and introduced the lead cell therapy candidate, bbHEP01, scheduled to enter clinical development in 2025. This candidate is aimed at addressing acute liver failure (ALF) and acute-on-chronic liver failure (ACLF), severe and life-threatening liver conditions. bbHEP01 involves encapsulated allogeneic induced hepatocyte-like cells (txHepatocytes) created through bit.bio's opti-ox™ precision cell programming technology. The therapy is designed to offer transient liver function support, allowing native liver recovery or acting as a bridge to transplant. This approach builds upon promising preclinical and clinical data showcasing the potential benefits of encapsulated donor-derived hepatocyte cell therapy.

One significant hurdle in developing hepatocyte cell therapies is the challenge of obtaining high-quality and sufficient quantities of liver cells. bit.bio's opti-ox™ precision cell programming technology addresses this bottleneck by ensuring a consistent and scalable supply of highly functional txHepatocytes. Initial clinical data for bbHEP01 are anticipated in 2026.

Mark Kotter, CEO at bit.bio, emphasized the company's mission to democratize access to cell therapies. The expanding portfolio of therapeutic bit.bio txCells™ aims to support a diverse pipeline of regenerative and immune cell therapies, developed independently or in collaboration with external partners. The company welcomed three new members to its Scientific Advisory Board (SAB): Drs. Katy Rezvani, Anil Dhawan, and Loïc Vincent. The SAB, chaired by stem cell pioneer Roger Pedersen PhD, will leverage the collective expertise to advance the company's initiatives efficiently and judiciously.

In addition to bbHEP01, bit.bio announced a broader therapeutic cell pipeline encompassing pancreatic islet cells, GABAergic neurons, and immune cells like myeloid and natural killer (NK) cells. These cell types offer the potential for multiple product candidates through various delivery methods, engineering modifications, or therapeutic targets. Initial development areas span metabolism and endocrinology, immunology, and neurology.

bit.bio intends to strike a balance between internal development and collaborative opportunities to propel its pipeline forward. Collaborations, such as the recent partnership with BlueRock Therapeutics focusing on regulatory T cell (Treg) based cell therapies, underscore the significance of collaborative efforts in bit.bio's cell therapy development strategy.

The newly appointed SAB members, including liver cell therapy expert Prof. Anil Dhawan, immune-oncology pioneer Prof. Katy Rezvani, and oncology scientist Dr. Loïc Vincent, bring diverse expertise to bolster bit.bio's strategic initiatives. Prof. Dhawan expressed excitement about bit.bio's unique precision cell programming technology, seeing it as a solution to a key challenge in cell-based therapies. He looks forward to collaborating with the bit.bio team to develop a life-saving treatment for ALF and ACLF patients in urgent need.

 

Source: businesswire.com

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