Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has revealed the latest results from a Phase I/II study for its Category 1 biologic product candidate ASKB589, which is being assessed as a treatment for solid tumors. The findings were presented at the 15th International Gastric Cancer Association (IGCA) meeting, highlighting the potential of this innovative therapy.
Phase I/II Study Design and Objectives
The first-in-human study evaluates the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of ASKB589 as a monotherapy or in combination with other treatments for advanced solid tumors. The study includes two parts: the ASKB589 monotherapy dose escalation and extension study (Part A) and the ASKB589 combination chemotherapy dose escalation and extension study (Part B).
Significant Efficacy in CLDN18.2-Positive Patients
As of April 25, 2023, in the ASKB589 Phase II clinical expansion study, 24 patients with high expression of CLDN18.2 who had measurable lesions and had at least one post-treatment tumor evaluation received 6mg/kg and 10mg/kg of ASKB589 combined with CAPOX treatment. The objective response rate (cORR) confirmed by the researchers was 79.2%, and the disease control rate (DCR) was 95.8%, indicating a significant therapeutic effect.
ASKB589’s Mechanism of Action and Global Potential
ASKB589 is an independently developed innovative anti-tumor biologic that utilizes antibody-dependent cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) to kill tumor cells. This novel approach has the potential to offer a new treatment option for patients with solid tumors, particularly those with CLDN18.2-positive tumors. No similar product has been approved anywhere in the world, positioning ASKB589 as a potentially groundbreaking therapy.-Fineline Info & Tech
