June 22, 2024

Genexine’s Therapeutic DNA Vaccine shows significant development

Facebook
Twitter
LinkedIn

Genexine , a publicly traded, clinical-stage Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, recently 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), MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy.

As per the source, a total of 60 patients with HPV 16- and/or 18- positive advanced cervical cancer were analyzed in the phase 2 treatment group. Top line results showed a Best Overall Response Rate (BORR) of 31.7% (19 of 60 patients). 6 patients (10.0%) had a complete response and 13 patients (21.7%) had a partial response. Median duration of response (DOR) was 12.3 months and overall survival (OS) was 17.2 months.

The 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 potential improvement in efficacy compared to monotherapy of immune checkpoint inhibitors, suggesting a beneficial effect of the combination therapy.

In the safety analysis (n=65) 22 of 65 patients (33.8%) had treatment-related adverse events (TRAEs) of any grade and three (4.6%) had grade 3 or 4 TRAEs. The combination therapy was found to be safe and tolerable with a similar safety profile to that of pembrolizumab monotherapy.

“There is an urgent need for better therapies for patients with advanced cervical cancer and the combination of a therapeutic DNA vaccine together 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 are very encouraging and appear to show a clear efficacy signal and the product appears safe and well tolerated. I am particularly pleased to see a clear efficacy signal in all patients, regardless of PD-L1 expression. Genexine’s combination therapy has strong appeal from a mechanistic perspective. 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 tumor microenvironment, appears to result in a strong, beneficial effect as demonstrated by major outcome measures such as BORR (31.7%) and OS (17.2 months) through the elimination of tumor cells and tumors.”

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

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

Source

Share.

RELATED POSTS

Suwaidi Pearl Farm traditional boat
RAKTDA signs agreement with FTI Group
BIBF’s Director, Dr. Ahmed Al Shaikh and Alba's Chief Executive Officer, Mr. Ali Al Baqali
The BIBF and Alba collaborate to empower Bahrain's workforce
Valu X Le Marche Signing Ceremony
Valu extends its partnership with Le Marche
  • Tamkeen Insurance banner
  • International Assurance

LATEST POSTS

Sprhava 887x444
Schneider Electric And Aveva Forges Partnership With IN-CORE Systèmes To Boost EV Battery Production Process
Aditum and Standard Chartered partner on first-of-its-kind fund structure wherein Ten funds approved; four already funded
Azizi Developments And Xylem Partnership For Riviera, Vista And Beach Oasis with the most technologically advanced, high-quality transfer-, booster-, and chilled-water pumps and sump pumps