BOSTON, MA, USA I September 8, 2018 I CARsgen Therapeutics, a clinical-stage company committed to developing Chimeric Antigen Receptor T cell therapies for cancer, presented its preliminary clinical data of a first-in-class CAR-Claudin18.2 T cell trial for treatment of pancreatic and gastric cancer at 2018 CAR-TCR Summit in Boston.

Among 12 relapsed/refractory patients enrolled, 8 have been observed with tumor regression of different degree. In an improved sub-cohort of 6 subjects, 5 patients showed objective response including 1 patient of complete response per RECIST 1.1 criteria.

A safe and effective therapy for gastric and pancreatic cancer is of huge unmet need. Over 754,000 patients die of gastric cancer every year, according to estimate from World Health Organization (WHO) in 2015. In particular, annual incidence of gastric cancer in China has already exceeded 600,000. Pancreatic cancer, also one of the malignancies of highest unmet medical needs, kills over 200,000 patients annually based on a Lancet report in 2016.

In 2017, CARsgen developed Claudin18.2-CAR-T cell in cooperation with Shanghai Cancer Institute. Experiments prove that Claudin18.2-CAR-T cell cancer is effective to eliminate gastric cancer tissues in mouse model without off-tumor toxicity, a study already published on Journal of National Cancer Institute (JNCI) in recent. In Aug 2017, CARsgen Therapeutics, together with Dr. Xianbao ZHAN, principal investigator from Shanghai Changhai Hospital, initiated the first-in-class Claudin18.2-CAR-T cell trial for treatment of pancreatic and gastric cancer with an enrollment of 12 patients. Preliminary results showed all patients were well-tolerated with Claudin18.2-CAR-T cells. After an optimized administration, 5 patients from a 6-subject sub-cohort have objective response. This is the highest ORR so far from all reported CAR-T cell trials for solid tumor treatment. 

“In the next, CARsgen plans a confirmative clinical trial in the U.S. This breakthrough owes to the trust from patients and their families and we can’t make it without the long-standing support from clinic team led by Dr. Xianbao ZHAN”, said Dr. Zonghai LI, Founder, CEO and CSO of CARsgen, who designed the Claudin18.2-CAR-T cell , “This is a great milestone for CAR-T therapies for solid tumors, also a great encouragement for CARsgen as we will continue our innovative research for more therapies to deliver our commitments to cancer patients.”

Link to the study on JNCI:

https://academic.oup.com/jnci/advance-article-abstract/doi/10.1093/jnci/djy134/5091914?redirectedFrom=fulltext

About CARsgen Therapeutics

CARsgen Therapeutics is a clinical-stage immune-oncology company committed to the development of the first-in-class and best-in-class CAR-T therapeutics. The company has launched several First-in-Class CAR-T clinical trials to treat the relapsed/refractory tumors, including CAR-GPC3-T trial for hHepatocellular carcinoma and squamous lung cancer, CAR-EGFR/ EGFRvIII-T trial for GBM, and CAR-Claudin18.2-T trial for gastric and pancreatic cancer. CARsgen also has ongoing clinical programs of the humanized CAR-CD19-T trial for leukemia and the fully human CAR-BCMA-T trial for multiple myeloma.

For more information, please visit www.carsgen.com

SOURCE: CARsgen Therapeutics