Istari Oncology Announces FDA Clearance of New IND to Open LUMINOS-102: PVSRIPO with and without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma

Source: businesswire, November 2020

Istari Oncology, Inc., a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug application (IND) for a Phase 2 clinical trial, LUMINOS-102, to investigate the efficacy and safety of PVSRIPO alone or in combination with a programmed death receptor-1 (anti-PD-1) inhibitor in patients with treatment-refractory melanoma.

PVSRIPO is a novel viral immunotherapy that activates a patient’s innate and adaptive immunity to facilitate a targeted anti-tumor immune response.

Following positive Phase 1 results in patients with unresectable and/or metastatic melanoma, the new IND will enable continued development of PVSRIPO for advanced melanoma.

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