Keji Pharmaceutical's CT041 completes the first patient enrollment in China's confirmatory phase II clinical trial

Keji Pharmaceutical (stock code: 2171.
HK), recently announced that CT041, the company's self-developed CAR-T cell candidate product, has completed the first patient enrollment in China's confirmatory phase II clinical trial at Peking University Cancer Hospital.
The main treatment Claudin18.
2 (CLDN18.
2)-positive advanced gastric cancer/esophagogastric junction adenocarcinoma (GC/GEJ) who had previously failed at least second-line therapy
.
As of the publication date, CT041 is the world's first and only CAR-T cell product candidate for the treatment of solid tumors that has entered a confirmatory phase II clinical trial; it is also the world's only approved CAR-T cell product from the US FDA, China's National Medical Products Administration and Health Canada IND/CTA-approved CAR-T cell product candidate targeting CLDN18.
2 under clinical trial study
.
The company believes that CT041 has the potential to become a backbone therapy for gastric/esophagogastric junction adenocarcinoma and pancreatic cancer in the future and benefit a large number of patients worldwide
.
List of important regulatory milestones for CT041: In 2020, CT041 was granted "orphan drug" designation by the US FDA for the treatment of gastric cancer/esophagogastric junction adenocarcinoma; in 2021, CT041 was granted "orphan drug product" by the European Medicines Agency (EMA) "qualified for the treatment of advanced gastric cancer; CT041 was granted "priority medicine" (PRIME) designation by the EMA for the treatment of advanced gastric cancer
.
CT041 is also the world's first solid tumor CAR-T product selected for the PRIME program; in 2022, CT041 was granted "Regenerative Medicine Advanced Therapy" (RMAT) qualification by the US FDA for the treatment of CLDN18.
2-positive advanced gastric cancer/esophagogastric combination adenocarcinoma
.
According to publicly available data, CT041 is the world's first RMAT-qualified CAR-T product for solid tumors
.
Dr.
Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer and Chief Scientific Officer of Keji Pharmaceuticals, said: "The data from the investigator-initiated clinical trial announced at the ESMO conference in September 2021 showed the promising therapeutic effect and favorable safety profile of CT041
.
In the following clinical trials, we will further explore the efficacy and safety of CT041 in the treatment of advanced gastric cancer/esophagogastric junction adenocarcinoma, and pancreatic cancer
.
We look forward to the positive results of CT041, a potential first-in-class CAR-T product in the world.
Research progress will meet the unmet medical needs as soon as possible and benefit the majority of patients
.
" About CT041 CT041 is a potential global first-in-class autologous CAR-T cell product candidate targeting CLDN18.
2 for the treatment of CLDN18.
2 positive solid tumors, mainly for the treatment of gastric cancer/esophagogastric junction adenocarcinoma and pancreatic cancer
.
Keji Pharmaceuticals conducted an investigator-initiated trial in China, a Phase Ib clinical trial in advanced gastric/EGJ adenocarcinoma and pancreatic cancer, a confirmatory study in advanced gastric/EGJ adenocarcinoma A Phase II clinical trial, and a Phase 1b clinical trial for advanced gastric or pancreatic cancer has been initiated in North America, and a pivotal Phase 2 clinical trial is also planned to be initiated in North America in 2022
.
About CLDN18.
2 CLDN18.
2 is a highly selective marker of cell lineage that is ubiquitously expressed in cancer tissues of 70% to 80% of gastric cancer patients and approximately 60% of pancreatic cancer patients
.
The expression of CLDN18.
2 in normal tissues is strictly restricted to the differentiated epithelial cells of the gastric mucosa and does not exist in the gastric stem cell region
.
CLDN18.
2 can be retained in malignant transformation of normal tissues, thereby making it expressed in a very large proportion of primary metastatic gastric cancer cells
.
In addition to gastric cancer tissue, CLDN18.
2 is expressed in other types of solid tumors (such as pancreatic cancer and esophageal cancer)
.
Keji Pharmaceutical is the first in the world to successfully identify, validate and report that CLDN18.
2 can be used as a relevant antigen in its ubiquitous and highly expressed solid tumors, and has the potential to be used for the development of CAR-T therapy for the treatment of solid tumors
.
About Keji Pharmaceuticals Keji Pharmaceuticals (stock code: 2171.
HK) is a biopharmaceutical company with operations in China and the United States, focusing on innovative CAR-T cell therapies for hematological malignancies and solid tumors
.
We have built an integrated cell therapy platform with in-house capabilities ranging from target discovery, antibody development, clinical trials to commercial-scale manufacturing
.
We address the major challenges of CAR-T cell therapy, such as improving safety, improving the efficacy of solid tumors and reducing treatment costs, through independent research and development of new technologies and a product pipeline with global rights
.
Our mission is to be the global biopharmaceutical leader that brings innovative and differentiated cell therapy to cancer patients worldwide and makes cancer curable
.