Seneca Therapeutics is pioneering the development of oncolytic immunotherapeutic candidates, with its lead asset, SVV-001, being a notable example. SVV-001 is an oncolytic virus that selectively targets and replicates within tumor cells expressing the Tumor Endothelial Marker 8 (TEM8) receptor, while remaining non-pathogenic to humans and animals. This virus has undergone extensive evaluation in over 30 preclinical cancer models and three clinical trials, demonstrating its safety and potential efficacy in treating various solid tumors, including neuroendocrine and pediatric cancers. The therapeutic mechanism of SVV-001 involves inducing apoptosis and cell lysis in tumor cells, which subsequently activates systemic immune responses through the release of tumor antigens and RNA, effectively transforming "cold" tumors into "hot" tumors that are more responsive to immune attack.

In addition to its core capabilities, Seneca Therapeutics is advancing the SVV-001 platform by incorporating therapeutic transgenes that enhance its anti-cancer effects while minimizing toxicity to normal cells. These armed SVVs are designed to express immune-modulatory elements, checkpoint inhibitors, and other therapeutic proteins specifically within the tumor environment. The company is also focused on overcoming challenges related to neutralizing antibodies, which can limit the effectiveness of repeated SVV-001 administrations. By targeting TEM8, which is expressed in a significant percentage of solid tumors and is associated with poor prognosis and drug resistance, Seneca Therapeutics aims to develop innovative treatments that not only attack cancer cells directly but also modulate the tumor microenvironment to improve overall therapeutic outcomes.

United States

Seneca Therapeutics was found by Dr. Paul Hallenbeck to develop the Seneca Valley Virus (“SVV-001”), a best in class oncolytic virus. SVV-001 is already in Phase I/II and has a clinical safety record in humans. SVV-001 binds to the TEM8 receptor which is common in many solid tumors like breast cancer, lung cancer and neuroendocrine tumors. SVV-001 is also being considered as a viral vector for gene therapy targeting the TEM8 receptor in solid tumors.

Seneca Therapeutics

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