Driven by the emerging clinical results of our ongoing Phase 1b/2a study in advanced liver cancer, we are more optimistic than ever about the ability of our personalized therapeutic cancer vaccines (PTCVs) to impact the standard of care for cancer patients. As we progress planning of a registrational clinical trial program, our focus is on improving the lives of as many cancer patients as possible by attaining a first regulatory approval for our PTCVs. Built from our GT-EPIC™ platform and capitalizing on its many benefits, our PTCVs harmonize with nature to create unique therapeutic vaccines for each patient which are designed to unleash the most powerful force against cancer: their body’s own immune system.
The tumor reductions observed in our ongoing Phase Ib/2a clinical trial validate our approach, which is to create a uniquely personalized therapeutic cancer vaccine for each patient. In our ongoing clinical trial for the treatment of advanced hepatocellular carcinoma (HCC) in 2nd line, each patient’s vaccine is designed based on their own unique tumor neoantigens (abnormal mutations and genomic variations produced by cancer cells). Unlike other platforms, in most every case, each patient’s PTCV includes all of their specific tumor’s neoantigens. Their truly personalized, tumor-specific, neoantigen-targeted cancer vaccine is rapidly manufactured and administered together with intradermal IL-12 adjuvant (T cell-stimulating cytokine) via our proprietary electroporation (EP) device.
The use of pIL12 plus EP serve to optimize the effectiveness of peripheral vaccination and ensure an effective CD4+/CD8+ T cell response to the patient’s neoantigens, a response seen in all patients studied. CD8s are the killing machines of the immune system, seeking out and destroying cancer cells. Our industry-leading CD4/CD8 response is not by accident; rather it results from our proprietary immunization methodology, optimized in extensive preclinical and clinical development. The effectiveness of our immunizations, which results from our ability to include all neoantigens and our use of pIL12 and EP, is leading us to observe meaningful tumor shrinkage and clinical benefit in our ongoing clinical trial. Equally important, to date our treatments have been unusually well tolerated by our patients. We are optimistic and passionate in our belief that with Geneos PTCVs, cancer vaccination has finally reached the end of the beginning and may be positioned to become the overdue, and welcomed, standard of care which has always been its promise.