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 National Medical Products Admin­istra­tion (NMPA).

"At the American Society of Hematology meeting in December 2018, our col­lab­o­rator, Dr. Songfu Jiang presented en­cour­ag­ing safety and efficacy data in patients with rrMM who received CT053 BCMA-CAR-T cells. The IND clearance of BCMA-CAR-T cells by China's NMPA is of great sig­nif­i­cance to CARsgen," 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. As part of the CT053 devel­op­ment plan, we also in­tend to submit an IND appli­ca­tion for BCMA-CAR-T cells to the U.S. FDA in 2019. 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.