Cervical Cancer Program Presents 35% Overall Response Rate

Genexine Inc. recently announced 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® in 65 patients with HPV 16- and/or HPV 18- positive recurrent or metastatic advanced cervical cancer.

GX-188E is a therapeutic DNA vaccine that encodes the E6/E7 fusion protein of HPV subtypes 16 and 18 and is administered intramuscularly by electroporation.

On January 8, 2023, Genexine disclosed the final efficacy analysis of a phase 1/2 clinical trial 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.

Furthermore, cancer patients with a CPS<1 showed a response rate of 29.2%, while those with a CPS≥1 showed a response rate of 38.9%.

With a disease control rate of 57.0%, this combination therapy was effective in more than half of the patients.

The overall survival was 16.7 months which compares favorably to other agents that have been granted accelerated approval by U.S. Food and Drug Administration in 2nd line cervical cancer treatment.

Neil Warma, President and CEO of Genexine, commented in a press release on January 8, 2023, "... the results ... 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 to become a leader in the oncology DNA vaccine market."

Genexine management is presenting these data at the JP Morgan conference on January 9-13, 2023.

'The most important things you can do to help prevent cervical cancer are to get vaccinated against HPV, have regular screening tests, and go back to the doctor if your screening test results are not normal,' says the U.S. Centers for Disease Control and Prevention.

Disclosure: This announcement was curated for mobile readership and is not paid content.