Turnstone Biologics Announces U.S. FDA Acceptance of IND for Immunotherapy Targeting HPV Positive Cancers

Phase I/II clinical trial studying MG1-HPV in combination with anti-PDL1 antibody in patients with cervical, oropharyngeal and other solid tumors to commence in Q2 2018

NEW YORK, NY, USA & OTTAWA, Canada I May 16, 2018 I Turnstone Biologics today announced it has received U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug Application (IND) for MG1-HPV for the treatment of patients with human papillomavirus (HPV) positive solid tumors. Additionally, Turnstone today announced that it 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.

“We are committed to helping patients in need of a safe and effective treatment for HPV positive cancers. Following FDA clearance of our IND, we look forward to advancing this promising combination of therapies into the clinic,” said Mike Burgess, MD, Ph.D., president of Research and Development at Turnstone. “We are excited to have the support of Roche in evaluating our novel MG1 platform in combination with atezolizumab, and believe the promise of our technology to unleash the power of T cells to treat a range of solid tumors is reinforced by this relationship.”

Turnstone’s MG1 virus is the first immunotherapy engineered to function as both a selective tumor-destroying oncolytic virus and an immune stimulating T cell vaccine. MG1 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. Building off of recently published scientific data, Turnstone will investigate MG1-HPV (MG1 expressing four different HPV viral antigens) as a safe and effective treatment option for patients with advanced metastatic cervical, oropharyngeal, and other HPV positive solid tumors.

About Turnstone Biologics

Turnstone Biologics is a clinical-stage, immuno-oncology company focused on the development of next-generation oncolytic viral immunotherapies for patients with a broad range of solid tumors. The company's first-of-its-kind investigational oncolytic viral immunotherapies combine the potent 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. Turnstone’srobust pipeline of early-stage investigational therapies, based on its Maraba (MG1) oncolytic virus platform, are in development for solid tumors. In addition to the MAGEA3 therapy currently in the clinic, and recent IND clearance for HPV positive cancers, Turnstone is also developing medicines for multiple other cancers. These immunotherapies are being evaluated as monotherapies and in combination with other cancer therapies, including checkpoint inhibitors. Turnstone has been financed by Versant Ventures, OrbiMed, F-Prime Capital Partners and FACIT. For more information, please visit www.turnstonebio.com.

SOURCE: Turnstone Biologics

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