SAN DIEGO--(BUSINESS WIRE)--Ichor Medical Systems, Inc. (Ichor) announced today that its investigational TriGrid® Delivery System (TriGrid) is being utilized in a Phase 1b/2 clinical trial to administer GX-188E, an investigational therapeutic HPV DNA vaccine developed by Genexine, Inc., in patients with human papilloma virus (HPV)-induced advanced non-resectable cervical cancer, in combination with an anti-PD-1 therapy (NCT03444376).
Cervical cancer is the fourth most common cancer affecting women worldwide and is almost always caused by infection with HPV. Preventative vaccines for cervical cancer are ineffective in women who are already infected with HPV, and despite advances in screening and HPV vaccination, a significant number of women develop advanced disease. Although chemotherapy is the standard first-line treatment for advanced cervical cancer, the prognosis remains poor and effective second line options are still needed.
Ichor’s patented TriGrid Delivery System uses electroporation to open pathways into cells to facilitate entry of a DNA vaccine into its intracellular site of action. The TriGrid has been utilized in >25 clinical studies, including randomized comparative studies demonstrating that administration of DNA vaccines with the TriGrid device significantly enhanced immune responses to the vaccines compared to conventional injection. A Phase 1 study using the TriGrid to deliver GX-188E in patients with high grade cervical intraepithelial neoplasia (CIN), a precancerous stage of cervical cancer, showed promising results with GX-188E demonstrating the ability to induce a tumor-specific immune response with evidence of lesion clearance (Nat Commun. 2014 Oct 30; 5: 5317).
Immuno-oncology is a rapidly evolving field of medicine designed to improve the ability of a patient’s immune system to detect and destroy tumors. The study has been initiated in Korea with plans to enroll up to 46 patients and was recently announced by Genexine.
Robert Bernard, Ichor Founder and CEO, stated, “Ichor’s TriGrid Delivery System is a platform technology used by an increasing number of Ichor partners for clinical delivery of their DNA vaccines where T-cell generation is a critical aspect of the prescribed immunotherapy. We are pleased through our Genexine partnership to expand TriGrid’s use into additional areas of immuno-oncology around the world.”
▶ About Ichor Medical Systems, Inc.
Ichor Medical Systems’ investigational TriGrid® Delivery System is the first integrated and fully automated device for electroporation-mediated nucleic acid administration in humans. Ichor, a privately-held biotech company based in San Diego, CA, is collaborating with partners to provide its enabling TriGrid platform as a means for delivery of nucleic acid-based drugs and vaccines in disease indications such as cancer, hepatitis B virus (HBV) infection, human papillomavirus (HPV) infection, and human immunodeficiency virus (HIV) infection, as well as for multiple biodefense agents. The TriGrid platform is also being developed for nucleic acid-based antibody delivery as a rapid countermeasure in the event of an infectious disease outbreak or biological weapons attack. Visit http://www.ichorms.com.
▶ About GX-188E:
GX-188E, currently being developed in Phase 2 clinical trials, is an HPV therapeutic DNA vaccine for cervical intraepithelial neoplasia (CIN) and HPV-induced cancers caused by persistent infection by high-risk HPV types, 16/18. A Phase 1 study demonstrated that GX-188E, a rationally designed HPV DNA vaccine to target HPV antigens preferentially on dendritic cells, elicited significant E6/E7 specific IFN-γ-producing T-cell responses in all CIN3 patients when administered intramuscularly by electroporation. Seven out of nine patients had complete regression of their CIN3 lesions, viral clearance, and exhibited enhanced antigen-specific polyfunctional CD8 T-cell responses within 36 weeks of follow-up. These results were published in October 2014 in Nature Communications.
▶ About Genexine:
Genexine, Inc., listed on KOSDAQ (095700) since 2009, is a leading biotherapeutics company focused on immuno-oncology and orphan disease. Genexine has robust pipelines in clinical and pre-clinical stages based on long-acting Fc fusion technology and therapeutic DNA technology. In the clinical stage, Genexine has GX-H9 (long-acting human growth hormone, hGH-hyFc) for both adult and pediatric growth hormone deficiencies, currently in multinational phase 2 trials. GX-188E therapeutic DNA vaccine for HPV-associated diseases is in Phase 2 in Europe and Korea for Cervical Intraepithelial Neoplasia 2/3, and has initiated a Phase 1b/2 trial in cervical cancer with GX-188E in combination with KEYTRUDA, an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, NJ, USA. Founded in 1999, Genexine has over 150 employees, and half of them are scientists with MSc, or Ph.D. Genexine is located in Pangyo Techno Valley near Seoul, Korea with a branch office in New York.
