Shanghai, China (Press Release) – CARsgen Therapeutics, a clin­i­cal-stage com­pany committed to devel­op­ing Chimeric Antigen Receptor T cell ther­a­pies for cancer, today announced that one of its leading drug can­di­dates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treat­ment of patients suffering from re­lapsed / refractory multiple myeloma (rrMM), has received Inves­ti­ga­tional New Drug (IND) clearance from the United States Food and Drug Admin­istra­tion (FDA). CT053 has also received IND clearance from the National Medical Products Admin­istra­tion in China four months ago and is the subject of an ongoing phase I clin­i­cal trial.

"At the 5th Annual Immunotherapy in Myeloma Scientific Workshop in Denver, Colorado, CARsgen provided an update of the clin­i­cal data of CT053 and showed that as of Feb. 28, 2019, 87.5% of the patients showed over­all response to the treat­ment. 70.8% of the patients had com­plete response and no grade 3 or higher cytokine release syn­drome (CRS) was observed in 24 heavily pre-treated patients with rrMM. The IND clearance of CT053 by the U.S. FDA is of great sig­nif­i­cance to patients" said Dr. Zonghai Li, founder, CEO and CSO of CARsgen. "According to JAMA Oncology, in 2016, there were about 130,000 cases of myeloma, which means from 1990 to 2016, incident cases of myeloma in­creased by 126% globally [1] and despite the devel­op­ment of novel ther­a­pies, multiple myeloma remains incurable and new treat­ment options are needed. Our goal is to con­tinue the devel­op­ment of novel, safe and effective immuno­therapies. This is our long-standing commitment to cancer patients world­wide."

About CARsgen Therapeutics

CARsgen Therapeutics is a clin­i­cal-stage immune-oncology com­pany committed to the devel­op­ment and com­mer­cial­iza­tion of CAR-T thera­peutics for unmet medical need. The com­pany has col­lab­o­rated with top hos­pi­tals in China to launch several First-in-Human studies such as CAR-GPC3-T for hepato­cellular carcinoma and squamous lung cancer, CAR-EGFR/EGFRvIII-T for glioblastoma multiforme and CAR-Claudin18.2-T for gastric and pancreatic cancer.

For more in­for­ma­tion, please visit: www.carsgen.com

References

[1] JAMA Oncol. 2018;4(9):1221-1227. doi: 10.1001/jamaoncol.2018.2128.

Source: CARsgen Therapeutics.