On January 8, 2023 Genexine (KOSDAQ: 095700), a publicly traded, clinical-staged Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, reported its updated results following the completion of its Phase 2 clinical study using GX-188E, its first-in-class proprietary DNA vaccine, in combination with KEYTRUDA (pembrolizumab), MSD’s (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy (Press release, Genexine, JAN 8, 2023, View Source [SID1234626009]).
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Having recently received the completed Clinical Study Report (CSR), Genexine has updated its primary efficacy numbers in the Phase 2 trial which evaluated the efficacy and safety of the combination of GX-188E and KEYTRUDA 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 a Objective Response Rate (ORR) of 35.0% (21 of 60 patients) indicating that of the 60 patients with advanced cervical cancer, 21 patients saw either an over 30% reduction in tumor size or complete remission.
Patients with a CPS<1 showed a response rate of 29.2%, while the patients with a CPS≥1 showed a response rate of 38.9% in the 60 patient evaluable population. With a disease control rate (DCR) of 57.0%, the combination therapy was found effective in more than half of the patients. The overall survival (OS) was 16.7 months which compares favorably to other agents that have been granted the accelerated approval by U.S. FDA in 2nd line cervical cancer treatment. The combination therapy was also safe and well tolerated. Genexine management will present these data together with a corporate update at various meetings during the upcoming JP Morgan conference to be held January 9-13, 2023 in San Francisco.
"We are pleased to be able to offer much-needed hope to patients showing an impressive response rate regardless of PD-L1 expression and extended survival of 16.7 months in advanced cervical cancer patients," said Neil Warma, President and CEO of Genexine. "After completing the final Blinded Independent Central Review (BICR) of the data, the results show an improvement over the top-line results we presented last September at ESMO (Free ESMO Whitepaper) and reinforce our belief that GX-188E could open up new treatment opportunities to all cervical cancer patients, especially PD-L1 negative patients who currently have limited options. We also appear to be extending patient survival beyond that of currently marketed drugs which should position us well as we move into larger Phase 3 studies in our effort to become a leader in the oncology DNA vaccine market."
GX-188E is a therapeutic DNA vaccine that encodes the E6/E7 fusion protein of human papillomavirus (HPV) subtypes 16 and 18, which are known to be a cause of over 70% of cervical cancer cases and is administered intramuscularly by electroporation. GX-188E induces immune cells to detect E6 and E7 proteins that only exist in cervical cancer cells, inducing apoptosis of tumor cells in an immune-oncological response without affecting healthy cells. Genexine is also conducting two ongoing clinical studies with GX-188E in combination with a check point inhibitor and a long-acting interleukin 7 in squamous cell carcinoma of head and neck (SCCHN). Results from these trials are expected in 2023.