Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced that its clinical trial filing for the Category 1 biologic product ASKG915 has been accepted for review by the US FDA. This marks a significant step forward in the development of ASKG915, a bifunctional fusion protein targeting programmed-death 1 (PD-1) and interleukin-15 (IL-15), designed to treat advanced solid tumors.
ASKG915 Profile
ASKG915 is a bifunctional fusion protein that targets PD-1 and IL-15. It achieves tumor targeting through the PD-1 antibody and is locally activated at the tumor site. Pre-clinical data have shown that ASKG915 exhibits good anti-tumor activity when activated in the tumor microenvironment. Its efficacy is significantly better than that of PD-1 antibodies used as monotherapy. Additionally, ASKG915 has demonstrated a favorable safety profile, with a significantly better therapeutic window compared to traditional cytokine drugs.
Future Implications
The acceptance of the clinical trial filing by the FDA positions Aosaikang to further explore the potential of ASKG915 in treating advanced solid tumors. This development underscores the company’s commitment to advancing innovative therapies in oncology, targeting unmet medical needs in the treatment of advanced cancers.-Fineline Info & Tech
