{"id":7236,"date":"2024-08-13T14:01:36","date_gmt":"2024-08-13T07:01:36","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=7236"},"modified":"2024-08-13T14:01:36","modified_gmt":"2024-08-13T07:01:36","slug":"biosyngens-brg01-receives-fda-approval-for-phase-ii-clinical-trial","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=7236","title":{"rendered":"Biosyngen’s BRG01 Receives FDA Approval for Phase II Clinical Trial"},"content":{"rendered":"

SINGAPORE<\/span>, Aug. 13, 2024<\/span> \/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<\/span> for the treatment of relapsed\/metastatic EBV-positive nasopharyngeal carcinoma, demonstrating a breakthrough in solid tumor treatment.<\/p>\n

\n<\/div>\n

The Center for Drug Evaluation (CDE) of the National Medicinal Product Administration (NMPA) in China<\/span> had previously granted approval for the pivotal Phase II clinical trial of BRG01. Patient enrollment for the Phase I clinical trial in China<\/span> 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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

Biosyngen has established itself as a leading biotech with a portfolio of cell therapies, including CAR-T, TCRT, and TIL, addressing various solid tumors \u00a0 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<\/span>, targeting a range of solid tumors such as lung and liver cancer.<\/p>\n

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.<\/p>\n

\u00a0<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n

SINGAPORE<\/span>, Aug. 13, 2024<\/span> \/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<\/span> for the treatment of relapsed\/metastatic EBV-positive nasopharyngeal carcinoma, demonstrating a breakthrough in solid tumor treatment.<\/p>\n

\n<\/div>\n

The Center for Drug Evaluation (CDE) of the National Medicinal Product Administration (NMPA) in China<\/span> had previously granted approval for the pivotal Phase II clinical trial of BRG01. Patient enrollment for the Phase I clinical trial in China<\/span> 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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

Biosyngen has established itself as a leading biotech with a portfolio of cell therapies, including CAR-T, TCRT, and TIL, addressing various solid tumors \u00a0 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<\/span>, targeting a range of solid tumors such as lung and liver cancer.<\/p>\n

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.<\/p>\n

\u00a0<\/p>\n

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