FDA Grants Orphan Drug Designation for Experimental Advanced Melanoma Treatment
North Carolina based Istari Oncology, Inc. announced that the U.S. FDA had granted orphan drug designation for PVSRIPO to treat advanced melanoma (stage IIB-IV). PVSRIPO is a novel viral immunotherapy based on the Sabin type 1 polio vaccine that activates a patient’s innate and adaptive immune system to facilitate an anti-tumor response and establish long-term immunologic memory to help prevent cancer’s return.
Unlike other viral immunotherapies, PVSRIPO has a distinct target (the poliovirus receptor CD155), widely expressed in the neoplastic cells of most solid tumors. Via CD155, PVSRIPO targets tumors with two primary mechanisms: 1) direct damage to and killing of cancerous cells; and 2) engaging innate and adaptive antitumor immune responses via sublethal infection of antigen-presenting cells in the tumor, which unleashes an inflammatory cascade resulting in sustained systemic antitumor immunity.
A new clinical study, LUMINOS-102, follows a successful Phase 1 monotherapy study of PVSRIPO in anti-PD1 refractory advanced melanoma in which patients who received 3 injections (6/12) had an overall response rate of 67% (4/6).
Matt Stober, President and CEO at Istari Oncology, stated in a press release issued on January 10, 2021, “This is just one of many milestones to come in 2021 as we continue to drive the clinical development of PVSRIPO across multiple indications.”