BRG01 Receives FDA Approval for Ph 2 Trial for the treatment of relapsed/metastatic EBV-positive NPC
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.
Share:
More News
“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”
“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.