FDA Greenlights Phase 2 Trial for BRG01 in EBV+ Nasopharyngeal Carcinoma

• A phase 2 trial evaluating BRG01, an Epstein-Barr virus (EBV)-specific chimeric antigen receptor (CAR) T-cell therapy, will begin.
• BRG01 is the first cell therapy to enter phase 2 trials in both the US and China for treating relapsed/metastatic EBV-positive nasopharyngeal carcinoma.
• BRG01 has shown to have an exceptional safety profile and has demonstrated preliminary efficacy in this patient population.

The FDA has approved the start of a phase 2 trial evaluating the EBV-specific CAR T-cell therapy BRG01 for the treatment of patients with relapsed/metastatic EBV-positive nasopharyngeal carcinoma.¹

With this approval, BRG01 is the first cell therapy to advance to phase 2 trials for this indication in both the US and China, representing a notable advancement in the treatment of solid tumors.

Previously, the Center for Drug Evaluation of the National Medicinal Product Administration (NMPA) in China had approved the pivotal phase 2 clinical trial of BRG01. Patient enrollment for the phase 1 trial (NCT05864924) of the agent began in China and the US in late January of this year.

Aa tumor sample under a microscope, highlighting its intricate cellular composition: © catalin - stock.adobe.com

All patients enrolled have completed the BRG01 infusion. The phase 1 study has successfully concluded dose-limited toxicity (DLT) observation and efficacy evaluation in 9 patients with advanced nasopharyngeal carcinoma who had at least 1 prior immune checkpoint inhibitor treatment, including PD-1 antibodies.

According to preliminary data, BRG01 has shown exceptional safety and efficacy. BRG01 is well tolerated and has not demonstrated any DLTs. More efficient disease control and tumor shrinkage effects were observed with dose escalation, and 75% of patients enrolled in the high-dose group showed necrosis and metabolic reduction of tumor lesions as determined by PET-CT.

In June 2023, the FDA granted an orphan drug designation to BRG01, as well as a fast track designation in July 2023.^2,3 Prior, the FDA cleared an investigational new drug application for the phase 1 trial in February 2023.

Along with BRG01, the company is also developing BRL03, a T-cell receptor therapy, for the treatment of solid tumors.⁴ A phase 1/2 trial is evaluating BRL03 for the treatment of patients with lung cancer, gastric cancer, and other advanced solid tumors. BST02, a tumor infiltrating lymphocyte therapy, is also being developed and is currently undergoing evaluation in a phase 1 clinical trial (NCT06173726) for treating liver cancer.

REFERENCES:

1. Biosyngen's BRG01 receives FDA approval for phase II clinical trial. News release. Biosyngen. August 12, 2024. Accessed August 13, 2024. https://tinyurl.com/bdr2k63s

2. Biosyngen’s first-in-class cell therapy BRG01 receives FDA fast track designation. News release. Biosyngen. July 10, 2023. Accessed August 13, 2024. https://tinyurl.com/44m5c4sr

3. Biosyngen's cell therapy BRG01 granted orphan drug designation by the U.S. FDA for treatment of nasopharyngeal cancer. News release. Biosyngen. June 6, 2023. Accessed August 13, 2024. https://tinyurl.com/ywnnk27c

4. Biosyngen received FDA approval for phase I/II clinical trials for BRL03, targeting lung cancer, gastric cancer and other advanced solid tumors. News release. Biosyngen. September 11, 2023. Accessed August 13, 2024. https://tinyurl.com/mfs65rh6