South Korea's MFDS determined that GX-188E met the requirements for fast track status after reviewing data from a mid-stage clinical study in advanced cervical cancer
Genexine has been granted fast track designation (FTD) from the Korean Ministry of Food and Drug Safety (MFDS) for its therapeutic DNA vaccine GX-188E (tirvalimogene teraplasmid) for advanced cervical cancer.
According to the South Korean biopharmaceutical company, the fast track designation was given based on the evaluation of the entire set of phase 2 data from a recently completed clinical trial in the targeted disease.
Korea’s health authority found that GX-188E met the requirements for the designation.
Genexine president and CEO Neil Warma said: “We are grateful to the Korean Health Authority for their careful evaluation and recognition that GX-188E has the potential to be a key life-saving drug for the treatment of advanced cervical cancer.
“We are committed to the cancer patients in which this therapy could be effective and appreciate that FTD could help to possibly speed our time to market to deliver the drug to patients more rapidly.
“We are in the process of designing the optimal Phase 3 study with GX-188E and expect to initiate that study this year.”
Recently, the South Korean firm presented the phase 2 trial data which evaluated the efficacy and safety of the combination of GX-188E and KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy.
According to Genexine, the trial was conducted on 65 patients (safety population) with HPV 16- and/or HPV 18- positive recurrent or metastatic advanced cervical cancer.
The objective response rate (ORR) for the final efficacy analysis, which included 60 patients, was 35%.
The study showed that 21 of the 60 patients with advanced cervical cancer experienced either a tumour size reduction of over 30% or complete remission, the biopharmaceutical company added.