Shanghai, China (Press Release) – CARsgen Thera­peutics Inc., a clin­i­cal-stage bio­pharma­ceu­tical com­pany, today announced the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) eligibility to its inves­ti­ga­tional CAR-T cell ther­apy fully human anti-BCMA (B Cell Maturation Antigen) au­tol­o­gous chi­meric an­ti­gen re­cep­tor (CAR) T Cells (ct053) for the treat­ment of re­lapsed or refractory multiple myeloma.

PRIME eligibility was based on clin­i­cal data from an ongoing CT053 BCMA CAR-T phase 1 study in China. The results from the trial were presented at an oral presentation on Sep­tem­ber 14, 2019 in Boston at the 17th Inter­na­tional Myeloma Workshop. As of June 30, 2019, 21 out of 24 myeloma patients (87.5%) who received a median of 4.5 prior lines of myeloma ther­apy showed objective response. 19 out of 24 patients (79.2%) achieved com­plete response. There was no grade 3 or higher cytokine release syn­drome. The duration of response data will be reported at a future date.

"PRIME eligibility is an im­por­tant regu­la­tory mile­stone in the con­tinued devel­op­ment and com­mer­cial­iza­tion of CT053 anti-BCMA CAR T cells," said Zonghai Li, M.D., Ph.D., chief exec­u­tive officer of CARsgen. "CT053 has dem­onstrated the poten­tial to be­come the best-in-class BCMA CAR-T ther­apy. PRIME desig­na­tion is invaluable to the ad­vancement of this cutting-edge thera­peutic to poten­tial mar­ket approval and being avail­able to patients as quickly as possible." The CT053 anti-BCMA CAR-T pro­gram has received Inves­ti­ga­tional New Drug (IND) clearance and Orphan Drug desig­na­tion from the U.S. Food and Drug Admin­istra­tion and authori­za­tion of its Clinical Trial Application (CTA) from Health Canada.

EMA's voluntary PRIME scheme sup­ports the devel­op­ment of promising med­i­cines that show a high poten­tial to benefit patients and target a sig­nif­i­cant unmet medical need. The status is granted to med­i­cines that may offer a major thera­peutic ad­van­tage over existing treat­ments. The pro­gram provides developers with en­hanced inter­action and early dialogue with the EMA to expedite drug devel­op­ment. Between the launch of PRIME in March 2016 through July 25, 2019, the EMA has received and assessed a total of 246 requests for eligibility. Of these, only 24 out of a total of 76 requests in on­col­ogy and hematology have been accepted into the scheme.

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 other First-in-Human studies such as anti-GPC3 CAR-T for hepato­cellular carcinoma and squamous lung cancer, anti-EGFR/EGFRvIII CAR-T for glioblastoma multiforme and anti-Claudin18.2 CAR-T for gastric and pancreatic cancer. http://www.carsgen.com

Source: CARsgen.