Genexine, a publicly traded, clinical-staged Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, 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.
“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,” said Neil Warma, Genexine’s President and CEO. “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.”
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.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.