Genexine has received the Korean Ministry of Food and Drug Safety’s (MFDS) fast track designation (FTD) for its first-in-class proprietary therapeutic DNA vaccine, GX-188E (tirvalimogene teraplasmid), for advanced cervical cancer.
MFDS concluded that GX-188E met the criteria for this designation after assessing the complete set of Phase II results from the clinical trial that was recently completed in advanced cervical cancer.
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 III study with GX-188E and expect to initiate that study this year.”
Recently, the company reported data from a Phase II clinical trial, which evaluated the efficacy and safety of the combination of GX-188E and MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) in a total of 65 subjects with HPV 16- and/or HPV 18- positive recurrent or metastatic advanced cervical cancer.
Final efficacy analysis was assessed in 60 patients and showed 35% objective response rate (ORR). This indicated that 21 of these patients with advanced cervical cancer saw either over 30% decline in tumour size or complete remission.
FTD is granted to a drug that is intended for the treatment of a serious condition under MFDS regulations, and the clinical or nonclinical data demonstrate the potential to address an unmet medical need.