NEW YORK – Geneos Therapeutics said Wednesday that its personalized vaccine GNOS-PV02 will be used in an upcoming clinical trial for advanced hepatocellular carcinoma patients who have progressed on or are intolerant to first-line treatment with a tyrosine kinase inhibitor.
The vaccine contains patient-specific neoantigen targets that will be identified through tumor sequencing. The company's GT-EPIC platform will be used to develop the personalized DNA-based therapies tailored to each patient's unique tumor mutations.
The trial will be an open-label, non-randomized, exploratory study which will evaluate the safety, biomarkers of immune activity, and antitumor activity of the vaccine in combination with a DNA plasmid encoded cytokine immunomodulator IL-12 (INO-9012) and PD-1 checkpoint inhibitor pembrolizumab (Merck's Keytruda). The researchers will look at CD8-positive and CD4-positive T Cell responses to assess immune activity.
"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," Mark Yarchoan, assistant professor of oncology at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, and an investigator on the study, said in a statement.
Two other firms are developing similar technologies. Transgene and NEC Corporation announced in early January that their immunotherapy vaccine based on 30 neoantigens was entering two Phase I trials for head and neck cancer as well as ovarian cancer.
Gritstone Oncology provided updated Phase I results from its two neoantigen-based immunotherapies at the JP Morgan Healthcare Conference earlier this month and expects to start Phase II trials in the second half of 2020.