Seoul, Korea – January 9th, 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, today 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® (pembrolizumab), MSD’s (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy.
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 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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., 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 clinical development including several undergoing Phase 3 registration trials. The Company's proprietary pipeline includes GX-188 for cervical cancer, GX-I7 (efineptakin alfa) for multiple cancers, GX-H9 (eftansomatropin alfa) for Pediatric Growth Hormone Deficiency and GX-E4 for CKD-induced anemia, among others. Genexine has established multiple partnerships with global companies in order to expedite product development and commercialization and create significant value. Genexine is listed on the Korean exchange (KOSDAQ: 095700) and is headquartered in Seoul, Korea. Genexine is committed to the well-being and care of patients worldwide.
Forward Looking Statements
This press release contains forward-looking statements regarding the business of Genexine, Inc. ("Genexine"). Any statement describing Genexine's goals, expectations, financial or other projections, intentions or beliefs, development plans and the commercial potential of Genexine's drug development pipeline, including without limitation GX-I7 (efineptakin alfa), GX-188E, GX-H9 (eftansomatropin alfa), GX- E4 is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to risks and uncertainties, particularly those challenges inherent in the process of discovering, developing and commercialization of new drug products that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.
Genexine's forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Genexine's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Genexine. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Genexine's programs are described in additional detail in Genexine's annual reports on DART (Data Analysis, Retrieval and Transfer System) internet site (https://dart.fss.or.kr/ ) of the Korean Financial Services Commission. Genexine assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.
For further information, please contact:
Mr. Jongsoo Lee