Seneca Therapeutics Receives FDA Clearance to Begin SVV-001 Phase I/II Clinical Study

PHILADELPHIA--(BUSINESS WIRE)-- Seneca Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to the development of novel immunotherapies for difficult to treat solid cancers announced today it had received FDA clearance to begin a Phase I/II clinical study utilizing Seneca Valley Virus (“SVV-001”) in combination with a checkpoint inhibitor. This Phase I/II study with SVV-001 is in patients that are TEM8 positive and SVV-001 permissive with neuroendocrine tumors or neuroendocrine carcinomas. The study should begin enrollment early in 2023.

About Seneca Therapeutics

Seneca Therapeutics was founded to capitalize on the profound tumor specificity of SVV and further the development of SVV-001 in several upcoming clinical trials and the creation and testing of armed derivatives selectively expressing gene product(s) that are inserted into the genome of SVV-001 that create additional anti-tumor effects.

Forward-Looking Statements

This press release contains “forward-looking statements” concerning the development of Seneca Therapeutics products, the potential benefits and attributes of those products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Seneca Therapeutics undertakes no obligation to update any forward-looking statements for any reason.

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Paul Hallenbeck
CSO and President

James Hussey

Source: Seneca Therapeutics

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