Genexine, Inc. announced updated results following the completion of its Phase 2 clinical study using GX-188E, its first proprietary DNA vaccine, in combination with KEYTRUDA, MSD’s anti-PD-1 treatment. After recently receiving the full clinical study report, Genexine has updated its primary efficacy data from the Phase 2 study evaluating the efficacy and safety of the combination of GX-188E and KEYTRUDA in a total of 65 HPV patients 16 advanced recurrent or metastatic and/or HPV positive cervical cancer 18. The final efficacy analysis evaluated on 60 patients showed an objective response rate of 35.0%, meaning that of the 60 patients with advanced cervical cancer, 21 patients saw more than a 30% reduction in tumor size or complete remission.
Patients with CPS < 1 had a 29.2% response rate, while patients with CPS=1 had a 38.9% response rate in the study population of 60 patients. With a disease control rate of 57.0%, the combination therapy was effective in more than half of the patients. Overall survival was 16.7 months, which compares favorably with other agents that have received US FDA accelerated approval for the second-line treatment of cervical cancer.
Combination therapy was also safe and well tolerated. Genexine management will present this data along with a company update at various meetings during the upcoming JP Morgan conference held January 9-13, 2023 in San Francisco. GX-188E is a therapeutic DNA vaccine encoding the human papillomavirus subtypes 16 and 18 E6/E7 fusion protein, known to cause over 70% of cervical cancer cases in utero, and which is administered via intramuscularly by electroporation.
GX-188E causes immune cells to detect E6 and E7 proteins that exist only in cervical cancer cells, inducing apoptosis of cancer cells in an immune-oncology response without affecting healthy cells. Genexine is also conducting two ongoing clinical trials with GX-188E in combination with a checkpoint inhibitor and a long-acting interleukin 7 in epidermal cancer of the head and neck. The results of these tests are expected in 2023.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc. Rahway, NJ, USA.