On May 29, 2024, BRL Medicine Inc., a company focused on gene and cell therapy, announced that the research results of the "Targeted CD19 Non-Viral PD1 Site-Specific Integration CAR-T Cell Injection" (Pipeline Code: BRL-201), developed based on its proprietary non-viral site-specific integration CAR-T platform for the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma, have been successfully selected for the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The latest clinical progress will be announced in a poster presentation format. This year's ASCO Annual Meeting will be held in Chicago, USA, from May 31st to June 4th local time. Notably, this is also the first time that BRL Medicine's BRL-201 research results have been publicly presented at an ASCO conference.

The research abstract of BRL-201 has been published on the official website of ASCO (Abstract number: 7031)

Regarding "BRL-201"

BRL-201 has been approved for China IND

On December 14, 2022, BRL Medicine Inc. officially received approval from the Center for Drug Evaluation (CDE) of the China Food and Drug Administration for the clinical trial application (IND) of BRL-201, entering the phase of registered clinical trials. This product is developed using BRL Medicine's proprietary non-viral targeted integration CAR-T platform and is the world's first targeted CD19 non-viral PD1-CAR-T product, indicated for relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). Non-Hodgkin lymphoma is a hematological malignancy originating in the lymphoid tissue, accounting for 80%-90% of all lymphomas. Although patients may achieve remission after initial treatment, relapse is common. Although CAR-T products have been approved for the clinical treatment of relapsed and refractory non-Hodgkin lymphoma, the overall efficacy still needs to be improved, and the toxic side effects caused by the massive cytokine release during treatment also need to be reduced.

The ASCO poster session will announce the latest clinical data of BRL-201 in the IIT study. The research results show that a total of 21 patients received BRL-201 treatment, with an objective response rate (ORR) of up to 100% and a complete response rate (CR) of 85.7%. While achieving significant efficacy, it did not cause cytokine release syndrome or neurotoxicity above grade 2 in any patient. To date, the first patient in the world to receive BRL-201 treatment from BRL Medicine Inc. has been cancer-free for more than 3 years. This study demonstrates the excellent clinical safety and efficacy of BRL-201 product, which can be said to be the best clinical result of high response rate and low toxicity in the global CAR-T cell therapy for refractory and recurrent lymphoma. In addition, the research results of this product were published in the top international academic journal Nature on August 31, 2022.

In the future, BRL Medicine will continue to be patient-centered and work with clinical experts to fully promote the transformation and implementation of this clinical research achievement, bringing better treatment options for the majority of cancer patients.