FDA Accepts Turnstone Biologics' IND for Immunotherapy Targeting HPV Positive Cancers

May 16, 2018

Turnstone Biologics  announced on 5/16/18 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 provideatezolizumab (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 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.

“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 is developing engineered MG1 candidates for a number of cancers including breast cancer, esophageal cancer, and non-small cell lung cancer.  Maraba is a single-stranded RNA virus isolated from sand flies around the Maraba region of Brazil, was determined by Turnstone to be an optimal platform for cancer therapeutics. Maraba was engineered to MG1 to optimize its safety, selectivity, manufacturability and potency to kill tumor cells, and transgene capacity was added for targeted expression of tumor-associated antigens and immunomodulatory agents.

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