Genexine recently announced it received Fast Track Designation from the Korean Ministry of Food and Drug Safety (MFDS) for GX-188E, its first-in-class proprietary therapeutic DNA vaccine targeting advanced cervical cancer.
Following an evaluation 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.
Genexine recently reported Phase 2 trial data which evaluated the efficacy and safety of the combination of GX-188E and KEYTRUDA®, anti-PD-1 therapy, in a total of 65 patients with HPV 16- and/or HPV 18- positive recurrent or metastatic advanced cervical cancer.
The final efficacy analysis evaluated in 60 patients showed an Objective Response Rate of 35%, indicating that of the 60 patients with advanced cervical cancer, 21 patients saw either over 30% reduction in tumor size or complete remission.
“We are grateful to the MFDS 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, in a press release on January 20, 2023.
“We are committed to the cancer patients in which this therapy could be effective….. We are designing the optimal Phase 3 study with GX-188E and expect to initiate that study this year (2023).”
HPV prevention vaccines are generally available at clinics and pharmacies worldwide.
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