Gradalis Awarded $9.9 Million Grant From the Cancer Prevention and Research Institute of Texas
The funds will be used to support the companys Phase 2 clinical study of Vigil\xae in platinum-sensitive patients who have recurrent ovarian cancer with a homologous recombination proficient (HRP) molecular profile. In Phase 1, 2A and 2B studies, Vigil has been shown to be well tolerated no Grade 3 or 4 treatment related adverse events were seen and no dose modifications were required.We are honored to have been approved by CPRIT for this award which provides additional capital to support the clinical development of Vigil and external validation of our technology by the world class experts who conducted medical, scientific and commercial diligence on behalf of CPRIT, said Steve Engle, CEO of Gradalis.Clonal neoantigens are tumor initiating mutations, and research by others has shown that the targeting of clonal neoantigens predicts survival in cancer patients. We expect the study will confirm Vigils ability to target each patients unique clonal neoantigens, the elimination of which has been shown by other research to be critical in achieving a durable overall survival benefit, commented John Nemunaitis, MD, Gradalis Chief Scientific Officer and co-founder.Following the extensive review of several drug development opportunities, CPRIT was impressed with Gradalis Vigil product activity and clinical benefit results. Results of Vigil in a Phase 2b study in HRP ovarian cancer patients are consistent with these findings.About VigilVigil is a novel, triple function immunotherapy platform that modifies a patients tumor by using bi-shRNA to reduce furin, an enzyme which facilitates immunosuppressive TGF beta protein production, and to maximize DNA expression of GM-CSF, which stimulates the immune system and attracts key immune system effector cells, including T cells. Our clinical trials have also demonstrated that Gradalis platform is better tolerated compared to standard cancer treatments since Vigil uses the patients immune system operating within its natural state of balance rather than in an artificial overdrive as with some technologies.