Bio4t2 News

Bio4t2 announces trial evaluating repeat infusions of CAR-T targeting solid tumors without lymphodepletion

(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.

About the clinical trial
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.

About Bio4t2^®
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.

Bio4t2 announces first patient infused with CAR-T targeting solid tumors

(San Diego, January 10, 2023) Bio4t2 dosed the first patient with T cells bearing a chimeric antigen receptor (CAR) that targets overexpression of BT-001 antigen present on various types of solid tumors. The CAR-T (B4t2-001) was developed from Bio4t2's PrismCore^™ platform.

"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.

About Bio4t2^®
Bio4t2 is a global clinical stage privately held biopharmaceutical company generating CAR-T that recognize self-antigens over-expressed on solid tumors using an exclusive technology. The proprietary PrismCore^™ platform combines algorithmic learning with supervised and iterative designs of CARs to rapidly generate genetically modified T cells with desired effector functions. With operations in China and USA, Bio4t2 can swiftly translate CAR-T into clinical trials to understand their therapeutic potential. Bio4t2 is a Bridgewest Group portfolio company.