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Istari Oncology Announces FDA Clearance of IND to Initiate LUMINOS-103: A Basket Trial Evaluating the Safety and Efficacy for PVSRIPO in Patients with Advanced Solid Tumors

April 19, 2021 Off By BusinessWire

Istari clinical trial program expands to evaluate PVSRIPO in a range of solid tumors

DURHAM, N.C–(BUSINESS WIRE)–Istari Oncology, Inc., a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug application (IND) for PVSRIPO in patients with solid tumors. LUMINOS-103 (NCT04690699) is a Phase 1/2 open-label, multi-center, single-arm basket trial evaluating the administration of PVSRIPO with or without PD-1/L1 inhibitors in adult subjects with solid tumor cancers. The trial will begin with two bladder cancer cohorts and is expected to initiate enrollment mid-2021.

PVSRIPO is a novel intratumoral viral immunotherapy that activates a patient’s innate and adaptive immune system to facilitate a systemic anti-tumor immune response. PVSRIPO enters solid tumor cells and antigen presenting cells (APCs) in the tumor microenvironment via CD155 (the poliovirus receptor). Because CD155 is expressed on virtually all solid tumors, PVSRIPO has the potential to treat many different cancers.

“This will be an important test of PVSRIPO’s versatility – and we’re optimistic,” said W. Garrett Nichols, MD, MS, Chief Medical Officer at Istari Oncology. “If the tumor can be biopsied, it can be injected, so there are a wide range of solid tumors we can investigate with PVSRIPO.”

This is the third IND clearance for PVSRIPO. This IND clearance follows other recent clinical trial progress including the initiation of LUMINOS-101 (NCT04479241) in recurrent glioblastoma and LUMINOS-102 (NCT04577807) in anti-PD-1/L1 refractory melanoma.

“LUMINOS-103 enables us to accelerate the clinical development program for PVSRIPO through the basket trial design, providing flexibility to evaluate multiple solid tumor types simultaneously,” said Matt Stober, Chief Executive Officer at Istari. “Even with the approval of anti-PD-1/L1 therapies in certain solid tumor cancers, we believe there is still room for improvement. PVSRIPO’s mechanism is synergistic with these therapies and as an intratumorally administered agent, we expect little additive toxicity.”

For more information about Istari Oncology and their ongoing clinical trials and research on PVSRIPO, visit www.istarioncology.com.

About PVSRIPO

PVSRIPO is an investigational immunotherapy based on the live attenuated Sabin type 1 poliovirus vaccine that has been genetically modified for safety. PVSRIPO has a distinct point of entry (the poliovirus receptor, CD155), which is expressed on virtually all solid tumors and antigen-presenting cells. Upon entry into the cell, PVSRIPO targets tumors via two primary mechanisms: 1) direct damage to and killing of cancerous cells; and 2) generating innate and adaptive antitumor immune responses via nonlethal infection of antigen presenting cells in the tumor, which stimulates a specific signaling pathway resulting in a sustained, robust type-I/III interferon-dominant response, with minimal release of unwanted cytokines. Its effects are potentiated by prior vaccination against poliovirus. PVSRIPO has been granted Breakthrough Therapy Designation and Orphan Status by the FDA in recurrent glioblastoma. PVSRIPO has also been granted Orphan Status by the FDA for advanced melanoma.

About Istari Oncology

Istari Oncology, Inc., headquartered in Research Triangle Park, North Carolina, is a privately held clinical-stage biotechnology company focused on novel immuno-oncology and immunotherapy platforms for the treatment of glioblastoma and a wide variety of tumors. The company was founded by Darell Bigner, MD, PhD and Matthias Gromeier, MD, of Duke University Medical Center in 2016. Istari licensed a broad range of patents and patent applications from Duke University and has access to additional intellectual property to continue clinical and commercial development of these technologies. The company’s primary platform currently in clinical development is PVSRIPO. For more information, please visit www.istarioncology.com.