Genexine announced it received Fast Track Designation (FTD) from the Korean Ministry of Food and Drug Safety (MFDS) for GX-188E (tirvalimogene teraplasmid), its first-in-class proprietary therapeutic DNA vaccine. Following an evaluation of the full set of Phase 2 data from the recently completed clinical trial in advanced cervical cancer, Korea's Health Authority (MFDS) concluded that GX-188E met the criteria for fast-track designation. Under MFDS regulations, FTD is given to a drug that is intended to treat a serious condition and the nonclinical or clinical data demonstrate the potential to address an unmet medical need.

Having such a designation can mean that a drug can move more quickly through the development and regulatory process in an expedited manner. Genexine recently reported Phase 2 trial data which evaluated the efficacy and safety of the combination of GX-188E and KEYTRUDA® (pembrolizumab), MSD's (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy, in a total of 65 patients (safety population) with HPV 16- and/or HPV 18- positive recurrent or metastatic advanced cervical cancer. The final efficacy analysis evaluated in 60 patients (efficacy evaluable population) showed an Objective Response Rate (ORR) of 35% (21 of 60 patients) indicating that of the 60 patients with advanced cervical cancer, 21 patients saw either over 30% reduction in tumor size or complete remission.