"This first-in-human study marks the initial therapeutic to be evaluated from Bio4t2's technology," said Dr. Laurence Cooper MD-PhD, Executive Chairman of the board. "PrismCore is capable of rapidly generating CAR-T to safely target self-antigens, opening a new frontier to delivering CAR-T to treat many types of solid tumors. This clinical trial is at the cutting edge of CAR-T biology and provides a path to treating the enormous numbers of patients who suffer from invasive cancers worldwide," added Dr. Cooper.

"We are excited to have started the clinical trial for our first CAR-T therapy targeting BT-001, which is a novel antigen for such therapies," said Farzad Haerizadeh, PhD, Chief Scientific Officer, and co-founder. "Our CAR-T is calibrated through PrismCore to discriminate between levels of BT-001 on tumors versus healthy cells. Indeed, B4t2-001 in preclinical studies in rodents and non-human primates, safely exhibited potent antitumor activity with long-term protective capacity. This trial helps validate the platform enabling the development of safe and effective CAR-T therapies against multiple types of solid tumors," said Haerizadeh.

About the clinical trial 

The phase 1 investigator-initiated study (clinicaltrials.gov NCT05621486) evaluates ascending doses of B4t2-001 targeting BT-001 in patients with solid tumors. This trial assesses the safety, tolerability, pharmacokinetic, pharmacodynamic, and preliminary efficacy of autologous CAR-T as a single agent after lymphodepletion in adult subjects at Shanghai East and Shanghai Artemed hospitals in China.