On August 21, 2018 Ichor Medical Systems, Inc. (Ichor) reported 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 (Press release, Ichor Medical Systems, AUG 21, 2018, View Source [SID1234529014])., in patients with human papilloma virus (HPV)-induced advanced non-resectable cervical cancer, in combination with an anti-PD-1 therapy (NCT03444376).
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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."