Turnstone Biologics Announces US FDA Acceptance of IND for Immunotherapy Targeting HPV Positive Cancers

Source: Turnstone Biologics Announces US FDA Acceptance of IND for Immunotherapy Targeting HPV Positive Cancers

NEW YORK & OTTAWA, Ontario–(BUSINESS WIRE)–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.

TECENTRIQ® (atezolizumab) is a registered trademark of Genentech, a
member of the Roche Group.

Published at Wed, 16 May 2018 11:30:51 +0000