Genexine Receives Fast Track Designation from Korean Health Authority (MFDS) for its promising DNA vaccine for advanced cervical cancer

SEOUL, South Korea–(BUSINESS WIRE)–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 it received Fast Track Designation (FTD) from the Korean Ministry of Food and Drug Safety (MFDS) for GX-188E (tirvalimogene teraplasmid), its first-in-class proprietary therapeutic DNA vaccine.

Following an evaluation of the full set 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. Under MFDS regulations, FTD is given to a drug that is intended to treat a serious condition and the nonclinical or clinical data demonstrate the potential to address an unmet medical need. Having such a designation can mean that a drug can move more quickly through the development and regulatory process in an expedited manner.

“We are grateful to the Korean Health Authority 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. “We are committed to the cancer patients in which this therapy could be effective and appreciate that FTD could help to possibly speed our time to market to deliver the drug to patients more rapidly. We are in the process of designing the optimal Phase 3 study with GX-188E and expect to initiate that study this year.”

Genexine recently reported Phase 2 trial data which evaluated the efficacy and safety of the combination of GX-188E and KEYTRUDA^® (pembrolizumab), MSD’s (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy, 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 an Objective Response Rate (ORR) 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.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Genexine

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 hyFc^TM fusion technology. The Company has multiple products in 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.

Contacts

Mr. Jongsoo Lee

Investor Relations, Genexine, Inc.

[email protected]