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bit.bio pipeline starts delivering clinical-trial candidates as SAB expands





Even for a company well known for not standing still, this week has been extraordinary for bit.bio.

The Cambridge-based cell coding company has come out of the blocks with all guns blazing, adding a trio of experts to its scientific advisory board, celebrating a drug candidate entering clinical trials and unveiling its cell therapy pipeline.

The Bit Bio team in the Abcam building with centre seated Florian Schuster CFO / COO, Tonya Frolov PhD Product Specialist, and Mark Kotter MD, PhD, Founder/CEO. Picture: Keith Heppell.
The Bit Bio team in the Abcam building with centre seated Florian Schuster CFO / COO, Tonya Frolov PhD Product Specialist, and Mark Kotter MD, PhD, Founder/CEO. Picture: Keith Heppell.

The bit.bio cell therapy pipeline consists of multiple txCells with potential to address significant unmet need across therapeutic areas including metabolism and endocrinology, immunology and neurology.

The most advanced therapeutic candidate, bbHEP01 – encapsulated allogeneic txHepatocytes for the treatment of acute liver failure (ACL) – is expected to enter clinical development in 2025 and generate initial clinical data in 2026.

Mark Kotter, CEO of bit.bio Picture: Keith HeppellRight, from top: Prof Anil Dhawan; Dr Katy Rezvani; and Dr Loïc Vincent
Mark Kotter, CEO of bit.bio Picture: Keith HeppellRight, from top: Prof Anil Dhawan; Dr Katy Rezvani; and Dr Loïc Vincent

And the three additions to the Babraham Research Campus company’s scientific advisory board (SAB) are Anil Dhawan, Katy Rezvani and Loïc Vincent.

Prof Dhawan is a liver cell therapy expert and professor in paediatric hepatology at King’s College Hospital in London, with a special interest in liver cell transplantation.

Dr Rezvani is an immune-oncology pioneer and professor of stem cell transplantation and cellular therapy at The University of Texas MD Anderson Cancer Center.

Anil Dhawan has joined bit.bio's scientific advisory board
Anil Dhawan has joined bit.bio's scientific advisory board

Dr Vincent is an oncology scientist with more than 20 years of biotech and pharma experience, and currently CSO at Affini-T Therapeutics.

Mark Kotter, CEO and co-founder 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.

Katy Rezvani has joined bit.bio's scientific advisory board
Katy Rezvani has joined bit.bio's scientific advisory board

“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 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.

Loic Vincent has joined bit.bio's scientific advisory board
Loic Vincent has joined bit.bio's scientific advisory board

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 to the thousands of ALF and ACLF patients that so desperately need it.”



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