bit.bio, the company coding human cells for novel cures, announced its cell therapy pipeline and declared its lead cell therapy candidate as it prepares to enter clinical development in 2025. The company also announced three key additions to its Scientific Advisory Board (SAB).
bit.bio’s lead cell therapy candidate (bbHEP01) is in development as a treatment for patients suffering from acute liver failure (ALF) and acute-on-chronic liver failure (ACLF), considered life-threatening liver conditions with high mortality. bbHEP01 consists of encapsulated allogeneic induced hepatocyte-like cells (txHepatocytes) produced by bit.bio’s opti-ox™ precision cell programming technology. The product is designed to provide transient liver function support, allowing native liver recovery or providing a bridge to transplant. This approach builds on current preclinical and clinical data demonstrating the feasibility and potential benefit of encapsulated donor-derived hepatocyte cell therapy.
A key challenge for the development of hepatocyte cell therapies is access to liver cells of sufficient quality and quantity. bit.bio’s precision cell programming technology opti-ox™ solves this bottleneck by providing a consistent and scalable supply of highly functional txHepatocytes. Initial clinical data are expected in 2026.
Mark Kotter, CEO at bit.bio said:
“bit.bio’s mission is to democratise access to cell therapies. Our growing portfolio of therapeutic bit.bio txCells™ will enable a broad pipeline of regenerative and immune cell therapies, which we will develop either independently or in collaboration with external partners. I’m excited to welcome Drs. Katy Rezvani, Anil Dhawan and Loïc Vincent to our SAB. Drawing on the combined expertise of our expanded SAB, we will proceed rapidly and thoughtfully, taking a risk-based approach. We will focus on areas of high unmet medical need where clinical risk has been mitigated by prior clinical studies. Our lead development candidate in acute liver failure exemplifies this approach.”
Beyond bbHEP01 and additional opportunities in txHepatocyte cell therapy, bit.bio today also announced its broader therapeutic cell pipeline which includes pancreatic islet cells, GABAergic neurons and immune cells such as myeloid and natural killer (NK) cells. Each cell type has the potential to give rise to multiple product candidates, for example by using different cell product delivery methods, engineering modifications, or therapeutic targets. Initial development areas for these cell types include metabolism and endocrinology, immunology, and neurology.
bit.bio intends to balance internal development and partnered development opportunities to advance its pipeline. Collaborations, such as the recent announcement with BlueRock Therapeutics focused on regulatory T cell (Treg) based cell therapies, will form an important aspect of the company’s cell therapy development strategy.
The bit.bio SAB is chaired by stem cell pioneer Roger Pedersen PhD, and includes cell reprogramming visionary Marius Wernig PhD and world-renowned expert in artificial intelligence and machine learning Thore Graepel PhD. The three new members of the SAB announced today are:
- Anil Dhawan MBBS, MD, FRCPCH – liver cell therapy expert and Professor in Paediatric Hepatology at King’s College Hospital in London with a special interest in liver cell transplantation.
- Katy Rezvani MD, PhD – immune-oncology pioneer and Professor of Stem Cell Transplantation & Cellular Therapy at The University of Texas MD Anderson Cancer Center.
- Loïc Vincent PhD – oncology scientist with more than 20 years of biotech and pharma experience, and currently Chief Scientific Officer at Affini-T Therapeutics.
On joining the bit.bio SAB, Professor Dhawan said:
“With its unique precision cell programming technology, bit.bio has the solution to the key problem for cell based therapies – namely access to an affordable, scalable and consistent supply of human cells. I am so excited that bit.bio’s lead candidate builds on our previous work in liver disease, and I am looking forward to working with the bit.bio team to develop a life-saving treatment for the thousands of ALF and ACLF patients that so desperately need it.”
SOURCE: BusinessWire