Biosyngen's BRG01 Receives FDA Approval For Phase II Clinical Trial

SINGAPORE, Aug. 12, 2024 /PRNewswire/ -- Biosyngen is proud to announce that the U.S. Food and Drug Administration (FDA) has approved its BRG01, an EBV-specific CAR-T cell therapy, to proceed with a pivotal Phase lI clinical trial. This marks the first cell therapy to enter Phase lI trials in both the U.S. and China for the treatment of relapsed/metastatic EBV-positive nasopharyngeal carcinoma, demonstrating a breakthrough in solid tumor treatment.

The Center for Drug Evaluation (CDE) of the National Medicinal Product Administration (NMPA) in China had previously granted approval for the pivotal Phase II clinical trial of BRG01. Patient enrollment for the Phase I clinical trial in China and the U.S. began in late January this year, with all participants having completed the BRG01 infusion. The Phase I study has successfully concluded dose-limited toxicity (DLT) observation and efficacy evaluation in nine patients with advanced nasopharyngeal carcinoma who had at least one prior immune checkpoint inhibitor treatment, including PD-1 antibodies.

Preliminary data indicates that BRG01 demonstrates exceptional safety and preliminary efficacy. All patients are late-stage cancer patients failing standard treatment including checkpoint inhibitors. BRG01 is well tolerated and expanded in patient with no dose-limiting toxicity. More efficient disease control and tumor shrinkage effects were observed with dose escalation. 75% patients in the high dose group showed necrosis and metabolic reduction of tumor lesions as determined by PET-CT.

Biosyngen aims to expedite BRG01's clinical development and commercial availability, offering new hope for nasopharyngeal cancer patients worldwide. This FDA's approval underscores BRG01's potential in tumor and anti-viral therapies and recognizes Biosyngen's innovation and R&D capability in cellular immunotherapy.

Biosyngen has established itself as a leading biotech with a portfolio of cell therapies, including CAR-T, TCRT, and TIL, addressing various solid tumors and hematologic malignancies. The company's multiple products have been granted approval to proceed with Phase I/II clinical trials in the U.S. and China, targeting a range of solid tumors such as lung and liver cancer.

Looking ahead, with Biosyngen's efficient execution and rapid development progress, the company anticipates further clinical breakthroughs in solid tumor cell therapies, providing new treatment options and hope for patients.

View original content to download multimedia:https://www.prnewswire.com/news-releases/biosyngens-brg01-receives-fda-approval-for-phase-ii-clinical-trial-302220007.html

SOURCE Biosyngen

First published on Tue, Aug 13, 2024

Enjoyed what you read? Great news – there’s a lot more to explore!

Dive into our content repository of the latest tech news, a diverse range of articles spanning introductory guides, product reviews, trends and more, along with engaging interviews, up-to-date AI blogs and hilarious tech memes!

Also explore our collection of branded insights via informative white papers, enlightening case studies, in-depth reports, educational videos and exciting events and webinars from leading global brands.

Head to the TechDogs homepage to Know Your World of technology today!

Disclaimer - Reference to any specific product, software or entity does not constitute an endorsement or recommendation by TechDogs nor should any data or content published be relied upon. The views expressed by TechDogs' members and guests are their own and their appearance on our site does not imply an endorsement of them or any entity they represent. Views and opinions expressed by TechDogs' Authors are those of the Authors and do not necessarily reflect the view of TechDogs or any of its officials. While we aim to provide valuable and helpful information, some content on TechDogs' site may not have been thoroughly reviewed for every detail or aspect. We encourage users to verify any information independently where necessary.

Tags:

Biosyngen BRG01 CAR-T cell therapy EBV-positive nasopharyngeal carcinoma FDA approval Phase II clinical trial solid tumor treatment

Join The Discussion

- Promoted By TechDogs -

Biotechnology