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Seneca Therapeutics Cleared by FDA to Start Phase I/II Oncolytic Virus Trial

NEW YORK – Seneca Therapeutics on Monday said it has permission from the US Food and Drug Administration to begin a Phase I/II trial of its oncolytic virus SVV-001 with a checkpoint inhibitor in patients with TEM8-positive neuroendocrine tumors.

The Blue Bell, Pennsylvania-based company licensed intellectual property related to TEM8 (tumor endothelial marker 8) from Memorial Sloan Kettering in 2020. Researchers there found that TEM8 is a receptor for Seneca Valley virus (SVV) and showed that the level of expression of TEM8 could predict which type of cancer cells can support replication of SVV, resulting in their death.

According to Seneca, SVV was discovered in 2001 by Novartis and has been tested in dozens of cancer models and in several clinical trials for solid cancers including neuroendocrine tumors, small cell lung cancer, and some pediatric cancers.

In neuroendocrine and melanoma mouse models expressing TEM8, Seneca demonstrated that SVV-001 could turn immunologically cold tumors hot and that intratumoral administration of SVV-001 in combination with a checkpoint inhibitor led to as much as a sixfold increase in anti-tumor response compared to SVV-001 or a checkpoint inhibitor alone. In those studies, investigators confirmed that SVV-001 infects and kills TEM8-positive cancer cells without infecting normal cells.