On July 7 , 2022 , Shenzhen Aixindawei Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Aixindawei" or "the Company") reported that the Phase I clinical study of its independently developed AKR1C3 enzyme – activated prodrug platform targeted anti-cancer new drug AST-001 injection successfully completed the first subject enrollment and the first dose at Jilin Provincial Cancer Hospital (Press release, Ascentawits Pharmaceuticals, JUL 7, 2022, View Source [SID1234650303]).

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This study is a Phase I/II clinical study of AST-001 injection in patients with advanced malignant solid tumors conducted in China (registration numbers: CTR20220934 , CTR20220935 ). The purpose is to evaluate the safety and tolerability of AST-001 monotherapy in patients with advanced malignant solid tumors and to evaluate the pharmacokinetic characteristics and preliminary efficacy of AST-001 and its metabolites in the subjects.

Dr. Jianxin Duan, founder and chairman of Aixindawei, said: " AST-001 injection is of great significance in the company’s R&D pipeline. Multiple preclinical in vitro and in vivo studies have demonstrated that AST-001 has good safety and broad-spectrum anti-tumor activity. In addition, AST-001 has shown significant efficacy in multiple in vivo animal tumor models with high expression of AKR1C3 and KRASG12D mutations. AST-001 obtained implicit clinical trial approval from NMPA in January 2022. With the joint efforts of the company, clinical principal investigators, research centers and other parties, we overcame the impact of the epidemic and successfully completed the enrollment of the first patient of AST-001 and the smooth administration of the drug, an important milestone. In the future, we will rapidly advance clinical research and strive to provide more treatment options for cancer patients as soon as possible to meet clinical urgent needs."

About AST-001

AST-001 is an innovative small molecule conjugate drug independently developed by the company through the AKR1C3 enzyme activation platform. It has the characteristics of First-In-Class and has global patents. After entering the tumor cells overexpressing the AKR1C3 enzyme, it is activated by the AKR1C3 enzyme to release effective drugs, achieving precise killing of tumor cells. Preclinical studies have shown that AST-001 has a broad spectrum of anti-tumor effects, significant effects and good safety.

About the AST-001-001 Clinical Study

The AST-001-001 study is a Phase I/II clinical study of AST-001 injection in patients with advanced malignant solid tumors conducted in China . The purpose of the study is to evaluate the safety and tolerability of solid tumor subjects receiving intravenous infusion of AST-001 , to evaluate the pharmacokinetic characteristics of AST-001 and its main metabolites in solid tumor subjects, and to preliminarily evaluate the efficacy and safety of AST-001 monotherapy in the treatment of malignant solid tumors. Professor Cheng Ying served as the principal investigator of the study, and the research was also conducted in multiple clinical research centers such as Jilin Cancer Hospital, Zhejiang Cancer Hospital, and the First Affiliated Hospital of Zhejiang University School of Medicine.