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. 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 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.

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 USA, Bio4t2 can swiftly translate CAR-T into clinical trials to understand their therapeutic potential. Bio4t2 is a Bridgewest Group portfolio company.