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.
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SOURCE Biosyngen