Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced receiving clinical trial approval for its Category 1 biologic product ASKG915 from the National Medical Products Administration (NMPA). The study will initially assess the therapy in patients with general advanced solid tumors.
ASKG915: A Bifunctional Fusion Protein Targeting PD-1 and IL-15
ASKG915 is a novel bifunctional fusion protein that targets programmed-death 1 (PD-1) and interleukin-15 (IL-15), developed using the SmartKine precursor technology platform. This drug is intended to treat advanced solid tumors and is designed to be locally activated at the tumor site, which could potentially minimize systemic side effects.
Pre-Clinical Data and Safety Profile
Pre-clinical data have demonstrated that ASKG915 exhibits good anti-tumor activity once activated in the tumor microenvironment, showing significantly better efficacy than PD-1 antibody monotherapy. Additionally, ASKG915 has produced a good safety profile, with a significantly better therapeutic window compared to traditional cytokine drugs. This suggests that ASKG915 could offer a more effective and safer treatment option for patients with advanced solid tumors.
Global Clinical Clearance and Potential Impact
As the first drug of its kind to enter clinics worldwide, ASKG915 obtained clinical clearance in the US in December of the previous year. The global clinical development of ASKG915 highlights the potential of this biologic to make a significant impact on cancer treatment, particularly for patients with advanced solid tumors.-Fineline Info & Tech
