China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced that a clinical trial filing for its first-in-class anti-tumor biologic drug SAL008 has been accepted for review by the National Medical Products Administration (NMPA). The drug, indicated for advanced solid tumors, has previously entered Phase I clinical trials in Europe. This marks a significant step forward in the development of innovative treatments for advanced solid tumors.
SAL008: Drug Profile and Mechanism
SAL008 is an in-house developed fusion protein composed of an IL-15/IL-15R α compound and an anti-CTLA-4 antibody. The IL-15/IL-15R α compound effectively promotes the proliferation and activation of CD8+ T cells and NK cells. The anti-CTLA-4 antibody targets the tumor microenvironment, depleting tumor regulatory T cells (Treg) and specifically inducing NK cell activation and degranulation to achieve anti-tumor immune effects.
Clinical Advantages
While CTLA-4 monoclonal antibodies have been proven effective in treating solid tumors, their response rates are limited, and they are associated with relatively high immunotherapy-related adverse reactions (irAE). SAL008, with its longer serum half-life, not only relieves immunosuppression through targeted antibodies but also promotes the proliferation of immune cells in the tumor microenvironment. Additionally, it reduces the number of immunosuppressive cells while enhancing immunoreactive cells. Importantly, SAL008 does not significantly increase irAE while enhancing the effects of immunotherapy.
Future Outlook
The acceptance of the clinical trial filing for SAL008 by the NMPA underscores Salubris Pharmaceuticals’ commitment to advancing innovative treatments for advanced solid tumors. By leveraging its unique mechanism of action, SAL008 aims to address significant unmet medical needs and improve patient outcomes.-Fineline Info & Tech
