22 May 2018 - - Ontario, Canada-based immuno-oncology company Turnstone Biologics has received US Food and Drug Administration clearance of its investigational new drug application for MG1-HPV for the treatment of patients with human papillomavirus positive (HPV) solid tumors, the company said.
Additionally Turnstone has entered into a clinical supply agreement with F. Hoffmann-La Roche Ltd (Roche) under which Roche will provide atezolizumab (Tecentriq), its anti-PDL1 antibody, for use in combination with Turnstone's Maraba virus immunotherapy platform, MG1.
Turnstone will investigate the safety and efficacy of MG1-HPV therapy in combination with atezolizumab across a range of HPV positive tumors in a Phase I/II clinical study expected to commence in the second quarter of 2018.
Turnstone's MG1 virus, the first known immunotherapy engineered to function both as an immune stimulating T-cell vaccine and a selective tumor-destroying oncolytic virus, directly attacks cancer cells and modifies the microenvironment to make tumor sites throughout the body susceptible to targeted killer T- cell responses, also induced by the virus.
Turnstone Biologics is focused on the development of next-generation oncolytic viral immunotherapies for patients with a broad range of solid tumors.
These investigational oncolytic viral immunotherapies combine the tumor-killing effects of an oncolytic virus with a tumor-targeted T-cell vaccine to harness an individual's own immune system to attack the tumor, with the goal of preventing recurrence and delivering a cure.
These immunotherapies are being evaluated as monotherapies and in combination with other cancer therapies, including checkpoint inhibitors.