Genexine’s first therapeutic DNA vaccine shows significant potential to prolong survival in advanced cervical cancer

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Seoul, South Korea–(BUSINESS WIRE)–Genexin (KOSDAQ: 095700), a publicly listed, clinical-stage Korean biopharmaceutical company engaged in the discovery and development of novel biologics for the treatment of unmet medical needs, today announced that GX- 188E, its first-in-class proprietary DNA vaccine, demonstrated potent efficacy and favorable safety in patients with advanced cervical cancer in a Phase 2 study when given in combination with KEYTRUDA® (pembrolizumab), anti-PD-1 therapy from MSD (Merck & Co., Inc., Rahway, NJ, USA).

A total of 60 patients with HPV 16 and/or 18 positive advanced cervical cancer were analyzed in the phase 2 treatment group. Early results showed a better overall response rate (BORR) 31.7% (19 out of 60 patients). 6 patients (10.0%) had a complete response and 13 patients (21.7%) had a partial response. The median duration of response (DOR) was 12.3 months and overall survival (OS) was 17.2 months.

BORR increased to 38.5% in PD-L1 positive patients with HPV 16+ and squamous cell carcinoma. Importantly, PD-L1 negative patients showed an ORR of 25.0%, which is extremely encouraging for this patient population, as it demonstrates a potential improvement in efficacy compared to inhibitor monotherapy. immune checkpoints, suggesting a beneficial effect of combination therapy.

In the safety analysis (n=65), 22 of 65 patients (33.8%) experienced treatment-related adverse events (EMTR) of any grade and three (4.6%) had EMTR grade 3 or 4. Combination therapy has been shown to be safe and tolerable with a similar safety profile to pembrolizumab monotherapy.

“There is an urgent need for better therapies for patients with advanced cervical cancer and the combination of a therapeutic DNA vaccine with checkpoint inhibition could be a strong alternative,” said Professor Sung-Jong Lee of the Catholic University of Korea, College of Medicine. and Investigator in the trial. “The data is very encouraging and seems to show a clear signal of efficacy and the product appears to be safe and well tolerated. I am particularly pleased to see a clear efficacy signal in all patients, regardless of PD-L1 expression. Genexin’s combination therapy has strong mechanistic appeal. This approach of using checkpoint inhibition to restore immune system function, combined with the vaccine’s effect of upregulating and increasing the influx of CD8+ and other immune cells into the microenvironment tumor, appears to result in a significant beneficial effect, as demonstrated by primary outcome measures such as BORR (31.7%) and OS (17.2 months) through removal of tumor cells and tumors. »

“We are very pleased to have been invited to present our first phase 2 data at ESMO and encouraged by the efficacy and safety demonstrated in this study,” said Neil Warma, President and CEO of Genexin. “The combination of GX-188E, our single-DNA vaccine, with pembrolizumab could represent a new standard of care for patients with recurrent or metastatic HPV 16/18-related cervical cancer, regardless of or the expression of PD-L1. We are encouraged by the ORR of over 31% but particularly excited by the efficacy signal seen in PD-L1 negative patients. This could open the door to a new therapy for this patient population that previously had limited treatment options.

The clinical trial was a single-arm, open-label Phase 2 trial conducted in South Korea in patients with advanced HPV-16 or HPV-18 cervical cancer who had progressed after standard treatment . Patients received GX-188E 2 mg intramuscularly at weeks 1, 2, 4, 7, 13, 19 and an optional dose at week 46, and pembrolizumab 200 mg intravenously every 3 weeks for up to at 2 years or until disease progression. The primary endpoint was blinded independent central reviewer (BICR) assessed ORR using RECIST version 1.1.

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

About Genexin

Genexine, Inc. is a publicly traded clinical-stage biotechnology company focused on the development and commercialization of next-generation immunotherapies and long-acting biologics. The main technology platforms are therapeutic DNA vaccine technology and hyFc® fusion technology. The Company has several products in clinical development, several of which are in Phase 3 registration trials. The Company’s proprietary pipeline includes GX-188E for cervical cancer and head cancer and neck, GX-I7 (efineptakine alfa) for several cancers, GX-H9 (eftansomatropin alfa) for growth hormone deficiency and GX-E4 for CKD-induced anemia, among others. Genexine has established multiple partnerships with global companies to accelerate product development and commercialization and create significant value. Genexine is listed on the Korean Stock Exchange (KOSDAQ: 095700) and is headquartered in Seoul, Korea. Genexine is committed to the well-being and care of patients worldwide.

About the GX-188E

GX-188E is a novel therapeutic DNA-based vaccine discovered by Genexine and jointly developed with the Onco-Innovation Unit of the National Cancer Center Korea (NOIU). It has a mechanism of inducing an antigen-specific T cell immune response to E6/E7, a carcinogenic protein produced by HPV types 16 and 18, which are the main causes of cervical cancer. uterus. Immune-activated T cells possess an immuno-cancer mechanism that effectively eliminates cervical cancer cells by inducing a cytotoxic T cell response. Genexine is currently developing GX-188E in cervical cancer and is also conducting two ongoing combination trials with GX-188E in squamous cell carcinoma of the head and neck (SCCHN).

About cervical cancer

Cervical cancer is cancer originating in the cervix and is caused by the abnormal growth of cells that have the ability to invade or spread to other parts of the body. Human papillomavirus (HPV) causes over 90% of cases and HPV strains 16 and 18 are responsible for the majority of high-grade cervical cancers. According to the WHO, cervical cancer is the fourth most common cancer in women worldwide, with an estimated 604,000 new cases and 342,000 deaths in 2020. A recent research report from Arizton estimated Cervical Cancer Therapeutics Market was $5.5 Billion in 2021 and is expected to grow at a CAGR of 4.14% over the period 2021-2027 to reach $7.1 Billion dollars, with targeted therapies expected to be the fastest growing segment over the forecast period.

Forward-looking statements

This press release contains forward-looking statements regarding the business of Genexine, Inc. (“Genexine”). Any statement describing goals, expectations, financial or other projections, intentions or beliefs, development plans and commercial potential for Genexin’s drug development pipeline, including without limitation GX-I7 (efineptakine 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, in particular the challenges inherent in the process of discovering, developing and commercializing safe and effective new drug products for human therapeutic use and in the effort to create a company around these drugs.

Genexine’s forward-looking statements also involve assumptions which, if they never materialize or prove incorrect, 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, such statements are based solely on facts and factors currently known to Genexine. Accordingly, you are cautioned not to rely on these forward-looking statements. These and other risks relating to Genexine’s programs are further described in Genexine’s annual reports on the Data Analysis, Retrieval and Transfer System (DART) website (https://dart.fss.or.kr/) of the Korea Financial Supervisory Service. Genexine undertakes no obligation to update any 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.

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