BioRay Pharmaceutical's BR105 Injection Clinical Trial Application (IND) Secures U.S. FDA Approval
Wednesday, October 25, 2023
BioRay Pharmaceutical Co., Ltd. (referred to as "BioRay") made a significant announcement on October 7th. They shared that their clinical trial application for BR105 Injection has received approval from the United States Food and Drug Administration (FDA), marking a notable milestone for BioRay as it represents their first project to receive FDA IND approval.
BR105 Injection is a humanized monoclonal antibody developed in-house to target SIRPα. This antibody can recognize common genotypes of SIRPα (V1, V2, V8) and disrupt the interaction between SIRPα and its ligand CD47. This disruption effectively eliminates the "don't eat me" signal that usually exists between macrophages and tumor cells. As a result, this activation empowers macrophages to carry out their tumor-phagocytosing function, ultimately leading to anti-tumor immunotherapy.
The effectiveness of targeting the CD47/SIRPα pathway has been validated in various tumor models, and prior clinical studies have indicated that this approach holds promise for a broad spectrum of anti-tumor activity. CD47/SIRPα-targeted therapy has shown positive results in various malignancies, including acute myeloid leukemia, lymphoma, head and neck squamous cell carcinoma, gastric cancer, among others.
Compared to CD47, SIRPα is a more specific target. By focusing on SIRPα rather than CD47, BR105 offers an enhanced safety profile. Furthermore, CD47 interacts with other proteins, such as TSP-1 and SIRPγ, creating a more intricate signaling network and increased risks in therapies targeting these interactions. Therefore, developing SIRPα antibodies to block the CD47/SIRPα signaling pathway emerges as a more promising strategy in the field of oncology drug development. It's worth noting that no medication targeting SIRPα has received global market approval thus far.
Currently, a Phase I clinical trial of BR105 Injection is underway in China, and preliminary results have affirmed its excellent clinical safety.
"The FDA IND approval of BR105 Injection as our first FDA approved clinical trial project is a significant milestone for BioRay, aligning with our global strategic vision for innovative drugs. In the fiercely competitive landscape of global innovative drug discovery and development, innovation is imperative. BioRay remains committed to substantial investments in innovation, cultivating a robust pipeline of innovative biopharmaceuticals. We are enthusiastic about the potential of these pipelines and BR105 to become leading therapies in the fields of autoimmunology and immuno-oncology, ultimately benefiting an expanding number of patients in both China and worldwide."
Source: prnewswire.com
