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bbHEP01

Development stage: Preclinical
Lead developer: bit.bio
Modality: iPSCs → Pluripotent Stem Cells → Stem Cell Therapies → Cell Therapies
Administration: Implant

Overview

bbHEP01 is an allogeneic, encapsulated cell therapy candidate composed of txHepatocytes—functional hepatocyte-like cells generated from induced pluripotent stem cells (iPSCs) using bit.bio's proprietary opti-ox (optimized inducible overexpression) technology. Developed for the treatment of acute liver failure (ALF) and acute-on-chronic liver failure (ACLF), bbHEP01 is designed to provide temporary metabolic and synthetic liver support. This "off-the-shelf" approach aims to stabilize patients, allowing for native liver regeneration or serving as a bridge to liver transplantation. The therapy is currently in preclinical stages, with clinical data generation anticipated to begin in 2026.

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