Innovate Group will announce the progress of two TST001 clinical trials at ASCO GI and IGCC International Gastric Cancer Conference

Chuangsheng Group (06628.
HK), a clinical-stage biopharmaceutical company with the ability to integrate the whole process of biological drug discovery, research and development, process development and production, announced that the US Phase I clinical trial of TST001 will be held on January 20-22, 2022 Presented as a Trial in Progress (TiP) poster at the American Society of Clinical Oncology Symposium on Gastrointestinal Oncology (ASCO GI) in San Francisco
.
Phase I clinical data of TST001 in China will be presented as a poster at the International Gastric Cancer Congress (IGCC) in Houston, March 6-9, 2022
.
Poster presentation American Society of Clinical Oncology Symposium on Gastrointestinal Oncology (ASCO GI) Abstract title: A Phase I Clinical Trial to evaluate the Safety, Tolerability and Pharmacokinetics of TST001 in Patients with Locally Advanced or metastatic Solid Tumors Phase I Clinical Trial Evaluating Safety, Tolerability and Pharmacokinetics of TST001 in Patients with Sexual Solid Tumors Abstract Number: TPS375 First Author: Dr.
Nashat Y.
Gabrail International Gastric Cancer Congress (IGCC) Abstract Title: A Phase I Study of TST001 (anti-Claudin18.
2 monoclonal antibody) in Patients with Solid Tumors Phase I clinical study of TST001 (anti-Claudin18.
2 monoclonal antibody) in patients with solid tumors Miao, Qi Changsong, Xia Zhenzhong, Shen Yu, Wang Jianming, Xu Li, Qi Chuan, Qian Xueming, Shen Lin Abstract ID: IGCC22-ABS-1152 First author: Dr.
Shi Ming TST001 is a high-affinity human resource independently developed by Chuangsheng Group Antibody which shows strong ADCC in vitro activity against Claudin18.
2-expressing tumor cells, and has good anti-tumor activity in tumor models with moderate and high Claudin18.
2 expression.
The phase I clinical study of TST001 has been in progress since April 2020.
Both the United States and the United States are carried out at the same time
.
TST001 has completed the dose escalation phase of clinical studies in China and is currently being tested as a phase Ib/IIa single agent in patients with multiple tumor types expressing Claudin18.
2, including gastric/gastroesophageal junction cancer, pancreatic cancer, and several other tumor types Therapeutic Trials In addition, a clinical trial of TST001 in combination with chemotherapy or PD-1 in first-line and previously treated patients with gastric/gastroesophageal junction cancer is also underway IGCC posters will present data from the dose escalation portion of the trial
.
The U.
S.
study of TST001 is nearing completion of the dose-escalation phase and will be a dose-expansion study in Claudin18.
2-expressing cancer patients.
ASCO GI poster TPS375 in patients with gastric/gastroesophageal junction cancer will demonstrate the US clinical study design
.
"The biological properties of Claudin18.
2 suggest that it is an ideal target for oncology drug therapy," said Dr.
Ming Shi, executive vice president and chief medical officer of global research and development of Transwin Group.
The combination is safe.
Previously, TST001 has also been granted orphan drug designation by the FDA and will be used for the treatment of gastric cancer and gastroesophageal junction cancer.
We are very much looking forward to the study of TST001 combined with chemotherapy and/or PD-1 for the majority of gastric cancer patients in the future.
Bringing new and more effective therapeutic options" About TST001 TST001 is a high-affinity humanized monoclonal antibody targeting Claudin18.
2 with enhanced ADCC and CDC activities, showing strong anti- Tumor Activity The drug is the second Claudin18.
2-targeted antibody therapeutic candidate developed globally, and was developed by Transwin Group through its independently developed Immune Tolerance Breakthrough (IMTB) technology platform.
ADCC) and complement-dependent cytotoxicity (CDC) mechanisms to kill Claudin18.
2-expressing tumor cells Using advanced bioprocessing techniques, the fucose content of TST001 was greatly reduced during production, further enhancing the NK cell-mediated TST001 The tumor-killing activity of TST001 has been in clinical trials in both China and the United States since August 2020 (NCT04396821, NCT04495296/CTR20201281).
The U.
S.
Food and Drug Administration (FDA) has granted TST001 for the treatment of gastric cancer and gastroesophageal junction Orphan drug designation for Japanese cancer
.
About Chuangsheng Group Chuangsheng Group is a clinical-stage biopharmaceutical company with comprehensive capabilities in biopharmaceutical discovery, R&D, process development and production
.
Headquartered in Suzhou, Chuangsheng Group has successfully established a global business layout: there are drug discovery, clinical and translational research centers in Suzhou, and the headquarters of Chuangsheng Group and a production base with continuous perfusion production technology as its core technology are also under construction.
Hangzhou has process and product development centers and drug production bases, clinical development centers in Beijing, Shanghai, Guangzhou and Princeton, USA, and foreign cooperation centers in Boston and Los Angeles, USA The development pipeline of Chuangsheng Group has ten treatments New drug molecules with antibodies, covering the fields of oncology, orthopedics and kidney diseases
.