VYRIAD INC — Department of Health and Human Services SBIR Phase I: 102

Description

PROJECT SUMMARY ABSTRACT Bladder cancer is a leading cause of death in the US and the most expensive cancer to treat Despite this there has been only one new bladder cancer therapy the checkpoint inhibitor atezoluzimab approved in the past years Oncolytic viruses viruses that selectively infect and kill cancer cells are a potent new class of immunotherapy that mediate anticancer activity by direct virus induced killing and robust activation of immune responses against tumor associated antigens Vyriadandapos s lead oncolytic measles virus product MV NIS has shown clinical safety and efficacy following intravenous and intraperitoneal treatment in patients with advanced multiple myeloma and ovarian cancer respectively and potently kills bladder cancer cell lines in in vitro studies Our goal is to develop oncolytic MV NIS as a new treatment for bladder cancer a malignancy that has demonstrated susceptibility to immunotherapy A majority of patients are diagnosed with non muscle invasive disease NMIBC of which approximately of patients fail first line therapy These patients and patients with muscle invasive disease MIBC have no effective therapeutic options and facing the likelihood of disease progression or metastasis often undergo radical cystectomy complete bladder removal which significantly impacts quality of life In this SBIR fast track application we propose to I confirm feasibility and identify optimal conditions for intravesical administration of MV NIS and II carry out a Phase clinical trial to evaluate intravesical MV NIS therapy in patients scheduled to undergo radical cystectomy This study will provide the critical demonstration of feasibility and safety of intravesical MV NIS administration as well preliminary indication of therapeutic efficacy to inform the decision to advance MV NIS therapy in a pivotal clinical trial to seek approval as a novel bladder cancer therapy We utilize an innovative clinical trial design that allows correlative analysis to define mechanism of action of MV NIS therapy including characterization of antitumor immune responses This will inform future studies to combine MV NIS therapy with approved checkpoint inhibitors to potentially develop a more potent therapeutic approach for patients with locally advanced or metastatic bladder cancer We are bringing together Vyriadandapos s team leading experts in oncolytic virotherapy development with Mayo Clinicandapos s nationally number one ranked Urology department to perform this study that will if successful lead to the approval of a new much needed treatment for bladder cancer patients PROJECT NARRATIVE Bladder cancer is a leading cause of death in the US associated with a poor quality of life high cost of care and few effective treatment options Oncolytic virotherapy is a powerful new therapeutic approach utilizing engineered viruses to destroy cancer Our goal is develop Vyriadandapos s lead oncolytic measles product MV NIS as potent and safe intravesical therapy to improve treatment and quality of life for bladder cancer patients