Turnstone Biologics Announces First Patients Enrolled in Phase 1/2 Clinical Trial Evaluating RIVAL-01 For the Treatment of Solid Tumors

NEW YORK, NY, USA I December 01, 2020 I Turnstone Biologics Corp., a clinical-stage biotechnology company pioneering the development of engineered viral immunotherapies, today announced enrollment of the first patients in a Phase 1/2a clinical trial (RAPTOR) of its RIVAL-01/TAK-605 candidate in patients with solid tumors, conducted in collaboration with Takeda Pharmaceutical Company Limited (“Takeda”). RIVAL-01 consists of Turnstone’s proprietary oncolytic vaccinia virus backbone encoding transgenes for Flt3 ligand, anti-CTLA-4 antibody and IL-12 cytokine, purposefully designed to work together to drive immune activity and re-program the microenvironment to be best suited for tumor eradication.

“The enrollment of the first patients into our Phase 1/2a trial is a key milestone for Turnstone and meaningfully advances our aim of transforming the treatment paradigm for people with cancer,” said Mike Burgess, Ph.D., President of R&D, Turnstone. “The meticulous design of our differentiated vaccinia virus platform enabled us to engineer RIVAL-01 to deliver three powerful immune modulating agents locally to primary and metastatic tumor sites, by either intratumoral or systemic administration. We look forward to sharing future updates as the study progresses.”

Turnstone’s RIVAL therapeutic pipeline is based on its proprietary vaccinia virus platform, which has been engineered for enhanced immune-stimulation and tumor cell selectivity, potent oncolysis and large transgene carrying capacity. The transgenes are designed to be expressed when the vaccinia virus, delivered either intratumorally or intravenously, enters and replicates in cancer cells. The resulting local production of these therapeutics at the site of tumors adds to the inherent oncolytic and microenvironment-modifying properties of the virus to form a powerful multi-modal attack on the disease. RIVAL-01 is being co-developed and co-commercialized under a global collaboration with Takeda.

“Takeda’s partnership with Turnstone continues to gain momentum. Our teams successfully collaborated to establish the RIVAL-01/TAK-605 clinical development plan while simultaneously working together to advance additional novel next-generation multi-payload oncolytic virus concepts to the clinic”, said Chris Arendt, Ph.D., Head, Oncology Therapeutic Area Unit, Takeda. “The trial enrollment represents an important step forward in our collaboration and ongoing efforts to leverage innate and adaptive immunity to overcome the limitations of current immuno-oncology therapies.”

The RAPTOR trial will evaluate the safety and efficacy of RIVAL-01 (formerly known as TBio-6517) administered intratumorally as a single agent and in combination with Keytruda® (pembrolizumab) in patients with solid tumors, including triple negative breast cancer, microsatellite stable colorectal cancer, melanoma and cholangiocarcinoma. Patients are currently enrolling in Phase 1 dose escalation, which will be followed by an expansion phase in specified tumor types in the Phase 2a portion of the trial.

Additional information about the trial, including eligibility criteria and a list of clinical trial sites, can be found at https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT04301011).

About Turnstone Biologics

Turnstone is developing a disruptive class of engineered viral immunotherapies, attacking cancer's complexity with medicines designed to fight malignant disease at multiple points of intervention. Turnstone’s proprietary vaccinia virus platform has been engineered to stimulate the immune system, drive antigen presentation and recognition, and re-shape the tumor microenvironment. In addition, the large transgene capacity of the virus can be utilized to deliver other agents and therapeutics directly to sites of tumors throughout the body for local expression, reducing the potential for systemic toxicity. Learn more at www.turnstonebio.com.

SOURCE: Turnstone Biologics

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