24 January 2023 - - Clinical-staged Korean biopharmaceutical company Genexine (KOSDAQ: 095700) has received Fast Track Designation from the Korean Ministry of Food and Drug Safety for GX-188E (tirvalimogene teraplasmid), its first-in-class proprietary therapeutic DNA vaccine, the company said.

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 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 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 (NYSE: MRK), Rahway, NJ, USA.

Genexine, Inc. is a publicly traded, clinical-stage biotechnology company focused on the development and commercialization of immunotherapeutics and next-generation long-acting biologics.

Its primary technology platforms are Therapeutic DNA vaccine technology and hyFcTM fusion technology. The company has multiple products in clinical development including several undergoing Phase 3 registration trials.