On April 29, 2022 AskGene reported that its lead program ASKB589 has recently achieved single agent efficacy in its on-going Phase I/II clinical trial (Press release, AskGene Pharmaceuticals, APR 29, 2022, View Source [SID1234613278]). Two gastric cancer patients have achieved partial response (PR) after receiving ASKB589 monotherapy for 6 weeks.

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ASKB589 is an innovative biological drug discovered and developed by AskGene. It is a recombinant humanized monoclonal antibody targeting claudin18.2. The drug mediates antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) through high-affinity binding to cancer cells. ASKB589 is intended for use in gastric and gastroesophageal junction cancers and pancreatic cancer. The multi-center Phase I/II clinical trial in China is led by Professor Shen Lin from Peking University Cancer Hospital.

In the on-going Phase I/II single-agent dose escalation and expansion study, two patients with advanced gastric cancer have achieved PR according to RECIST 1.1 after 6 weeks of treatment with ASKG589 monotherapy. The target lesions were significantly reduced, some non-target lesions disappeared, and tumor markers were significantly reduced. The two patients were among the 10 mg/kg and 20 mg/kg group, respectively, and were relapsed/refractory after multiple lines of chemotherapy and anti-PD-1 antibody therapy. In addition, in the dose escalation study of ASKB589 in combination with CAPOX chemotherapy for the first-line treatment of gastric cancer, three patients in the 3 mg/kg and 6 mg/kg dose groups achieved PR according to RECIST 1.1, after 6 weeks or 12 weeks of treatment.

Professor Shen Lin, Vice President of Peking University Cancer Hospital and Director of the Division of Gastrointestinal Oncology, said: "Claudin18.2 has become an exciting target in the field of gastric cancer treatment. Currently, many companies are developing drugs targeting CLDN18.2. ASKB589 is the third (among the first wave) in China to obtain a CDE clinical trial license. The clinical trial is progressing smoothly, and patients in both high-dose single-agent and combination therapy have shown good tolerance. In terms of efficacy, ASKB589 has also shown efficacy in the single-agent group. The dose-escalation study of combination therapy is also progressing smoothly."

Dr. Jianfeng (Jeff) Lu, Chief Executive Officer of AskGene, said: "Gastric cancer is one of the malignant tumors with high morbidity and mortality in China. The development of innovative drugs for gastric cancer has not been the focus of international companies. We hope to bring safe and efficacious innovative drugs to gastric cancer patients. Claudin18.2 is a very promising target for gastric cancer treatment. The significant anti-tumor activity observed in single-agent therapy is a very gratifying start. The company will accelerate clinical development, hoping to benefit more patients as soon as possible."