Personalized Liver Cancer Immunotherapy Study Launches

Geneos personalized neoantigen-targeting vaccine GNOS-PV02 is a tumor-specific DNA plasmid product

A Pennsylvania based cancer-focused immunotherapy company announced its personalized vaccine GNOS-PV02 will be used in an upcoming clinical trial for advanced Hepatocellular Carcinoma (HCC) patients who have progressed on or are intolerant to first-line treatment with a tyrosine kinase inhibitor.

Announced by Geneos Therapeutics in a press release on January 29, 2020, the personalized neoantigen-targeting vaccine, GNOS-PV02, is a tumor-specific DNA plasmid product designed and manufactured for each patient based on the unique tumor variations identified by sequencing each patient's tumors. 

This an important study since HCC is one of the fastest-growing cancers in the USA, and a significant unmet need exists to find more efficacious treatments.

HCC accounts for the majority of primary liver cancers and often occurs in patients with chronic liver diseases, such as hepatitis B, hepatitis C, and fatty liver disease.

Globally, liver cancers are the 4th most common cause of cancer-related death and rank 6th in terms of annual incidence.

To date, immunotherapies have shown limited efficacy with two PD-1 inhibitors (pembrolizumab and nivolumab) approved as second-line treatments following a tyrosine kinase inhibitor.

In this clinical trial, GNOS-PV02 will be combined with a DNA plasmid-encoded cytokine immunomodulator IL-12 (INO-9012) and standard of care PD-1 checkpoint inhibitor (pembrolizumab).

The primary study goals are to evaluate treatment safety, biomarkers of immune activity, with special emphasis on CD8+ T cell responses, and clinical outcomes.

Geneos has exclusively licensed the DNA Medicines platform, INO-9012 and CELLECTRA® device for in vivo delivery of DNA plasmids from Inovio Pharmaceuticals (NASDAQ: INO) for use in the development of personalized cancer treatments. 

The two DNA based products, GNOS-PV02, and INO-9012 will be administered to cancer patients via intradermal administration using the CELLECTRA® 2000 ID device.

Dr. Mark Yarchoan, Assistant Professor of Oncology at Johns Hopkins and Investigator for the GT-30 advanced HCC study said in the press release, "Checkpoint inhibitors and other immunotherapies have advanced the cancer treatment field and have had a significant impact on clinical outcomes.” 

“However, every patient's tumor is unique and in order to further improve outcomes, I believe that personalized approaches are critical.” 

“I'm excited about this clinical trial utilizing Geneos' innovative personalized treatment approach in combination with approved immunotherapy for the treatment of advanced HCC,” concluded Dr. Yarchoan. 

Geneos Therapeutics’s approach is to target unique neoantigens from individual patient tumors to develop novel treatments for cancer. Our technology is designed to identify relevant neoantigen targets and then design, manufacture, and deliver tumor-specific neoantigen-targeted (TSNA-targeted) personalized immunotherapies. 

Cancer Immunotherapy news is published by Vax-Before-Cancer.