On November 15, 2021 Carsgen Therapeutics reported that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) eligibility to CT041, an autologous CAR T-cell product candidate against the claudin18.2 protein (CLDN18.2) for the treatment of gastric/gastroesophageal junction cancer (GC/GEJ) (Press release, Carsgen Therapeutics, NOV 15, 2021, View Source [SID1234618646]).
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As of this announcement, CT041 is the only CLDN18.2-targeted CAR T-cell product candidate globally that is being studied in clinical trials with IND approvals from both the FDA and the NMPA. Also, CT041 is the first solid tumor CAR T-cell product to be granted PRIME eligibility. CARsgen is currently the only company with two CAR T-cell products active in the PRIME scheme.
"Access to PRIME support and enhanced interaction with EMA is an important milestone in accelerating the development and commercialization of CT041 CAR T cells," said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen. "We believe that CT041 has the potential to become a backbone therapy for gastric/gastroesophageal junction cancer and pancreatic cancer in the future. With the mission of ‘making cancer curable,’ we will continue our efforts to develop more innovative technologies and products for cancer patients worldwide."
About CT041
CT041 is an autologous CAR T-cell product candidate against the protein CLDN18.2 that has the potential to be the first in its class globally. CT041 targets the treatment of CLDN18.2-positive solid tumors with a primary focus on GC/GEJ and pancreatic cancer (PC). CT041 has demonstrated promising therapeutic efficacy and favorable safety in ongoing clinical trials.
In addition to the investigator-initiated trials in China, CARsgen has initiated a Phase Ib/II clinical trial for advanced GC/GEJ and PC in China and a Phase 1b clinical trial for advanced gastric or pancreatic adenocarcinoma in the United States. CT041 received Orphan Drug designation for the treatment of GC/GEJ from the U.S. FDA in 2020 and Orphan Medicinal Product designation for the treatment of gastric cancer from the EMA in 2021. CARsgen has applied to the NMPA for the required regulatory approval for initiating the pivotal Phase II clinical trial in China. CARsgen also intends to conduct a pivotal Phase 2 clinical trial in North America in 2022.
About PRIME
PRIME is a scheme operated by the EMA to support the development of medicines that target an unmet medical need. Through PRIME, EMA offers early and proactive support to medicine developers to optimize the generation of robust data and enable accelerated assessment of medicine applications.
The PRIME scheme helps patients to benefit as early as possible from treatments that may significantly improve their quality of life. To be accepted for PRIME, a medicine must show its potential to offer a major therapeutic advantage over existing treatments, or to benefit patients without treatment options.