NEW YORK – Seneca Therapeutics, a clinical-stage drug developer based in Philadelphia, said it has received positive feedback from the US Food and Drug Administration allowing it to start Phase I/II studies of its SVV-001 in Q2 of 2021.
The planned Phase I/II study will evaluate SVV-001, an oncolytic immunotherapy based on the Seneca Valley Virus (SVV), in combination with a checkpoint inhibitor for patients with neuroendocrine tumors or carcinomas. SVV-001 is designed to bolster the ability of patients' immune systems to recognize tumor cells and improve their response to checkpoint inhibitors.
The company said this study will enroll patient that harbor biomarkers, such as the receptor for SVV, which is expected to increase the likelihood that they will respond to the SVV-001 and the checkpoint inhibitor.
Last month, Seneca announced that it had licensed the intellectual property rights to tumor endothelial marker 8 (TEM8) from Memorial Sloan Kettering. TEM8 is a protein expressed on tumor cells that may be used to identify which patients will respond to SVV-001.