(SAN DIEGO and SHANGHAI, October 17, 2023) Bio4t2 received regulatory approvals to repeatedly administer patients with T cells engineered to express a chimeric antigen receptor (CAR) targeting BT-001, an antigen on solid tumors identified using the PrismCore™ platform. The CAR-T, termed B4t2-001, are predicted to engraft without preparative chemotherapy (lymphodepletion) based on the Bio-Engine™ technology enabling multiple infusions for each recipient to further improve the therapeutic effect.

The PrismCore platform generates CAR-T that recognizes overexpressed self-antigens on solid tumors. Bio-Engine adapts the CAR-T to transiently recognize a subset of circulating blood cells to boost the numbers of infused genetically modified T cells without the need for preparative chemotherapy. Bio4t2 harnesses these technologies to unlock the commercial potential of CAR-T in patients with invasive cancers.

A prior pilot investigator-initiated trial (clinicaltrials.gov NCT05621486) demonstrated that B4t2-001 can engraft to the range of 40 to 50% of circulating lymphocytes, even when lymphodepletion was omitted, and resulted in anti-tumor effects.

"This new phase 1 trial builds off our pilot clinical study which concluded a few weeks ago," said Dr. Laurence Cooper MD-PhD, Executive Chairman of the board. "Treating solid tumors depends on identifying targets that are uniformly expressed across cancer cells and engrafting CAR-T without immunological exhaustion. We combine our PrismCore and Bio-Engine technologies to achieve both goals and advance our cutting-edge CAR-T for the many patients with solid tumors," added Dr. Cooper.

“PrismCore identifies targets on invasive cancers and Bio-Engine harnesses normal blood cells to create a niche for CAR-T engraftment without the use of preparative chemotherapy," said Farzad Haerizadeh, PhD, Chief Scientific Officer, and co-founder. “Based on the success of our pilot clinical study, Bio4t2’s CAR-T is predicted to attack the tumor again and again without the cost, complexity, and toxicities, associated with lymphodepletion," said Haerizadeh.

The phase 1 investigator-initiated study (clinicals.gov NCT06072989) evaluates intra-patient repeat administration and inter-patient ascending doses of B4t2-001 targeting BT-001 without lymphodepletion in adult patients with solid tumors at Shanghai East and Shanghai Artemed hospitals in the People's Republic of China. Furthermore, this trial assesses the safety, tolerability, pharmacokinetic, pharmacodynamic, and preliminary efficacy of autologous CAR-T.

Bio4t2 is a global clinical stage privately held biopharmaceutical company generating CAR-T that recognizes solid tumors using exclusive technologies. The proprietary PrismCore platform combines algorithmic learning with supervised and iterative designs of CARs to rapidly generate genetically modified T cells that recognize overexpressed self-antigens. The unique Bio-Engine technology enhances engraftment without preparative chemotherapy (lymphodepletion) facilitating repeat dosing of CAR-T. With operations in People's Republic of China and USA, Bio4t2 swiftly translates CAR-T into clinical trials to understand their therapeutic potential. Bio4t2 is a Bridgewest Group portfolio company.