January 2023 - Dr. Laurence Cooper

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

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

NEWS PROVIDED BY Bio4t2 → Jan 10, 2023

SAN DIEGO, Jan. 10, 2023 /PRNewswire/ — 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

PrismCoreTM 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.

“This clinical trial is at the cutting edge of CAR-T biology and provides a path to treating invasive cancers.”

“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 PrismCoreTM 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.

Media Contact:

Jenny Bourbiel
jbourbiel@bridgewestgroup.com

General Contact:
Farzad Haerizadeh
info@bio4t2.com

Secure Transfusion Solutions Granted its First Biologics License Application Approval

NEWS PROVIDED BY Secure Transfusion Solutions → Jan 03, 2023, 15:05 ET

AUSTIN, Texas, Jan. 3, 2023 /PRNewswire/ — Secure Transfusion Solutions (STS), a private life sciences company pioneering innovative methods to overcome the nation’s growing blood and platelet shortage, has received approval of its first Biologics License Application (BLA) from the Center for Biologics Evaluation and Research (CBER) division of the U.S. Food and Drug Administration (FDA), allowing for interstate distribution of pathogen reduced apheresis platelets from its Trusting Heart Blood Center located in Edina, Minnesota.

Each day, hospitals around the U.S. require an average of 7,000 platelet doses, and with the national blood and platelet shortage, a significant number of hospitals struggle to meet this need. According to a recent survey of 481 U.S. hospitals, 22.3% of these institutions experience platelet supply challenges on a monthly or more frequent basis.[1]

“The BLA approval marks a critical milestone for STS, as we can now offer enhanced platelet supply chain integrity and improved confidence in sourcing for hospitals nationwide,” said Vijai Mohan, Chief Executive Officer of STS. “Through a continued commitment to excellence, obsession with quality, and in appreciation of the collaboration with our counterparts at the FDA, STS is now in position to accelerate the licensure approval process for our newer, and future Trusting Heart Blood Centers.”

Laurence Cooper, MD PhD, lead independent board director of STS added “as a pediatric bone marrow transplantation physician, I know firsthand the consequences of an unstable platelet supply and the deleterious effect it has on patient outcomes. We celebrate this important milestone of receiving the first BLA approval and its impact for the blood supply across the US and for our company.”

About the Platelet Shortage

The national blood and platelet shortage impacts the operations of hospitals and the management of patients. Most platelet transfusions at hospitals are used to prevent bleeding in certain cancer patients and those undergoing cardiac surgeries and organ transplants.

Platelets have a shorter shelf life than typical blood components alone and must be transfused within five to seven days from collection, driving a continuous need. Exacerbated by industry challenges to the effective recruitment of blood donors, demand for platelet units continues to exceed available supply.

About Secure Transfusion Solutions

Secure Transfusion Solutions (STS) is a life sciences company pioneering innovative methods to overcome the nation’s growing blood and platelet shortage. Its purpose is to restore hope, build trust and improve quality of life by increasing patient access to readily available and safe transfusion solutions. An innovative company able to execute strategies out of reach of others in the transfusion space, STS provides healthcare institutions with safe and consistent service and true supply chain diversification. By partnering with STS, hospital systems increase confidence in the sourcing of blood components, better preparing them to meet evolving patient transfusion needs.

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