Nature Medicine Releases Results of Investigator-Initiated Trial of CARsgen CT041 Claudin18.2 CAR T Cells in Gastrointestinal Cancers

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SHANGHAI, May 10, 2022 /PRNewswire/ — CARsgen Therapeutics Holdings Limited (stock code: 2171.HK), a company focused on innovative CAR T therapies for the treatment of hematological malignancies and solid tumors, announces that the interim phase I trial results of an investigator-initiated trial of CT041 have been published in Nature Medicine (https://www.nature.com/articles/s41591-022-01800-8), which is one of the top international medical journals in the Nature portfolio (2-year impact factor of 53.44).

(PRNewsfoto/科济药业)

The publication, titled “Claudin18.2-specific CAR T cells in gastrointestinal cancers: interim results from the phase I trial” presented the results of a phase I multicenter open-label clinical trial conducted in China to explore the the safety, efficacy and cellular pharmacokinetics of CT041 in patients with advanced CLDN18.2 positive gastrointestinal cancers. Interim trial results showed that among 37 patients with advanced gastrointestinal cancers, CT041 was well tolerated with a manageable safety profile, including no dose-limiting toxicities within 28 days of infusion, no syndromes ≥ Grade 3 cytokine release, no neurotoxicity and no treatment. linked death. The objective response rate (ORR) and disease control rate (DCR) in patients with gastrointestinal cancers were 48.6% and 73.0%, respectively. In patients with gastric cancer or gastroesophageal junction (GC/GEJ) cancer, the ORR and DCR reached 57.1% and 75.0%, respectively.

As of the date of this announcement, CT041 is the the first and only in the world CAR T-cell candidate for the treatment of solid tumors entering a confirmatory Phase II clinical trial.

The corresponding author of the article, Teacher Lin Shen of Beijing Cancer Hospital, said, “CAR T-cell therapy has successfully treated a variety of hematological malignancies, while few breakthroughs have been achieved in solid tumors. CT041 is the first CAR T-cell class product candidate against Claudin18.2 In this clinical trial, CT041 showed promising efficacy and manageable safety for patients with gastrointestinal cancers, especially gastric cancer, which does not have not responded to previous conventional treatments. unprecedented efficacy against solid tumors. Publishing the interim results of the trial in Nature Medicine allows us to better share the results with our peers and advance CAR T-cell therapy in solid tumors. It also demonstrates the potential for more innovative solutions, China-developed medicines to reach and benefit patients in global markets.”

“This study is made possible through the joint efforts of CARsgen’s research and development team and our researchers, as well as the support and trust of patients and their families. has entered a confirmatory Phase II clinical trial, we will spare no effort to advance clinical trials and benefit patients as soon as possible,” Shen added.

Dr Zonghai Li, Founder, Chairman, Managing Director and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, said, “Congratulations to the research team led by Professor Shen. We thank the patients participating in the trial for their trust and thank all the researchers for their dedication. The publication of the interim results of the CT041 trial in Nature Medicine demonstrates the high quality and value of this trial. The development of innovative therapies has always been an arduous journey, especially for CAR T-cell therapies effective against solid tumors. Despite these challenges, we began collaborating with our researchers in 2015 for the treatment of hepatocellular carcinoma and glioblastoma. Since then, we have continued to explore innovative technologies and products. I am very pleased to see the groundbreaking interim results of CT041 in research led by Professor Shen. We will continue joint efforts with our researchers in the global clinical development of CT041.”

About CT041

CT041 is an autologous CAR T-cell product candidate against CLDN18.2 protein that has the potential to be first-in-class globally. CT041 targets the treatment of CLDN18.2-positive solid tumors with a primary focus on GC/GEJ and pancreatic cancer (PC).

In addition to investigator-initiated trials in ChinaCARsgen has initiated a phase Ib clinical trial for advanced GC/GEJ and PC, a confirmatory phase II clinical trial for advanced GC/GEJ in China and launched a phase 1b clinical trial for advanced gastric or pancreatic adenocarcinoma in North America. CARsgen also intends to initiate a pivotal Phase 2 clinical trial in North America in 2022.

CARsgen plans to submit an NDA to the NMPA in China in the first half of 2024 and to submit the BLA to the US FDA in 2024.

In 2020 and 2021, CT041 received Orphan Drug Designation from the US FDA for the treatment of GC/GEJ and Orphan Medical Product Designation from the EMA for the treatment of advanced gastric cancer. In November 2021, CT041 has obtained PRIME eligibility from the EMA for the treatment of advanced gastric cancer. In January 2022CT041 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the US FDA for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma with CLDN18.2 positive tumors.

As of the date of announcement, CT041 is the only CLDN18.2-targeted CAR-T cell product candidate worldwide that is being studied in clinical trials with IND/CTA approvals from the FDA, NMPA and Health Canada.

About CARsgen Therapeutics Holdings Limited

CARsgen is a biopharmaceutical company active in China and in the United States and focuses on innovative CAR T-cell therapies for the treatment of hematological malignancies and solid tumors. The company has built an integrated cell therapy platform with in-house capabilities that span target discovery, antibody development, clinical trials and commercial scale manufacturing. CARsgen has in-house developed new technologies and a product pipeline with global rights to address key challenges of CAR T-cell therapies, such as improving the safety profile, improving efficacy in the treatment of solid tumors and reducing treatment costs. The company’s vision is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable.

For more information, visit https://www.carsgen.com/

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