Final Phase 2 Clinical Results Reveal Promising 35% Response Rate for Genexine’s Cervical Cancer Program: Check Out the Corporate Overview at JP Morgan Conference

Genexine, a Korean biopharmaceutical company dedicated to discovering and developing treatments for unmet medical needs, has released new results from their Phase 2 clinical study of GX-188E, a first-of-its-kind DNA vaccine, used in combination with KEYTRUDA®, an anti-PD-1 therapy from MSD’s (Merck & Co., Inc., Rahway, NJ., USA). This revolutionary research is a major step forward in the medical field, offering a potential solution to previously unsolved medical issues.

Genexine is pleased to announce the results of the Phase 2 trial evaluating the combination of GX-188E and KEYTRUDA® in 65 patients with HPV 16- and/or HPV 18- positive recurrent or metastatic advanced cervical cancer. The final efficacy analysis revealed an impressive Objective Response Rate (ORR) of 35.0% (21 of 60 patients), meaning that 21 of the 60 patients experienced a reduction of tumor size of at least 30% or experienced complete remission! This is a significant step forward in the fight against advanced cervical cancer.

Genexine management will be presenting impressive efficacy and safety data of their combination therapy at the upcoming JP Morgan conference held from January 9-13, 2023 in San Francisco. Their 60 patient evaluable population showed a response rate of 29.2% for those with a CPS<1 and 38.9% for those with a CPS≥1, with a disease control rate (DCR) of 57.0%. Furthermore, the overall survival (OS) was 16.7 months, which is comparable to other agents that have been granted accelerated approval by the U.S. FDA in 2nd line cervical cancer treatment. This combination therapy is proving to be both effective and well tolerated.

Genexine is excited to announce a breakthrough in the fight against advanced cervical cancer. After a Blinded Independent Central Review (BICR) of the data, the results show a response rate of up to 16.7 months for patients regardless of PD-L1 expression. This is a dramatic improvement over the top-line results presented last September at ESMO, and offers hope to cervical cancer patients, especially those who are PD-L1 negative and have limited options. With these impressive results, Genexine is confident that GX-188E will become a leader in the oncology DNA vaccine market and extend patient survival beyond that of currently available treatments.

Genexine’s GX-188E is an innovative therapeutic DNA vaccine that could revolutionize the way cervical cancer is treated. The vaccine encodes the E6/E7 fusion protein of human papillomavirus (HPV) subtypes 16 and 18, which are known to cause over 70% of cervical cancer cases. Administered intramuscularly by electroporation, GX-188E induces immune cells to detect E6 and E7 proteins from cervical cancer cells, inducing apoptosis of tumor cells in an immune-oncological response without affecting healthy cells. Genexine is currently conducting two clinical studies on 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, potentially ushering in a new era in cancer treatment.

KEYTRUDA® is an innovative, life-changing medication developed by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. It has the potential to revolutionize the treatment of many serious illnesses and conditions, providing new hope to patients and their families.

About Genexine

Genexine is a pioneering clinical-stage biotechnology company that is committed to improving the health and wellbeing of people worldwide. By leveraging its proprietary Therapeutic DNA vaccine technology and hyFcTM fusion technology, the company has developed a portfolio of innovative immunotherapeutics and next-generation long-acting biologics. Several products are currently in Phase 3 registration trials, including 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. Genexine is listed on the Korean exchange (KOSDAQ: 095700) and is headquartered in Seoul, Korea, and has established a number of strategic partnerships with global companies to facilitate product development, commercialization, and create significant value.

Forward Looking Statements

Genexine is committed to the development of innovative drugs with the potential to revolutionize the treatment of human diseases. Our pipeline includes GX-I7 (efineptakin alfa), GX-188E, GX-H9 (eftansomatropin alfa), and GX-E4, all of which have the potential to be safe and effective therapeutics. However, the road to discovery, development, and commercialization of these drugs is filled with risks and uncertainties. We are determined to overcome these challenges to create a successful business and bring these treatments to the public.

Genexine strives to provide its clients with reliable, forward-looking statements based on the best available facts and data. However, these statements may not always prove to be accurate, and if they do not, could lead to materially different results than those expressed or implied. To stay informed on potential risks associated with Genexine’s programs, we encourage you to review our annual reports on the DART (Data Analysis, Retrieval and Transfer System) internet site of the Korean Financial Services Commission. Genexine is dedicated to keeping our clients up-to-date, and will update any forward-looking statements as required by law.

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