Seneca Therapeutics, Inc. Receives Positive Feedback from FDA on Reactivation of the SVV-001 IND and Phase I/II Protocol

PHILADELPHIA--(BUSINESS WIRE)--Seneca Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to the development of oncolytic immunotherapeutics for cancer based on Seneca Valley Virus (SVV-001), announced today the receipt of positive guidance from the FDA on the reactivation of the SVV-001 IND and Phase I/II protocol. The Phase I/II study will be in combination with a checkpoint inhibitor and include patients with either neuroendocrine tumors (NET) or carcinomas (NEC). The Phase I/II clinical study should begin during 2^nd quarter, 2021.

"We are pleased to receive this guidance from FDA regarding reactivating the SVV-001 IND and starting our Phase I/II protocol in patients with neuroendocrine tumors,” stated Dr. Paul Hallenbeck, Founder, President, and Chief Scientific Officer of Seneca Therapeutics.

SVV-001 is a best in class oncolytic immunotherapeutic intended to enable and broaden the number of patients that respond to a checkpoint inhibitor. Seneca’s approach follows a resurgence in the field of oncolytic immunotherapeutics. These agents have demonstrated the ability to synergize with immune checkpoint inhibitors to elicit a robust immune response to the tumor. Further, STI’s trial will also involve enrolling only patients that have key biomarkers, such as the receptor for SVV, which will enhance the probability of obtaining significant patient responses.

Currently, patients with neuroendocrine tumors have limited treatment options. Seneca is seeking to demonstrate an improvement on ORR and OS responses when SVV-001 is utilized in combination with immune checkpoint blockade vs the historical data from several large studies with the immune checkpoint blockade agent alone.

About Neuroendocrine Cancers:

It is estimated that there are over 150,000 patients with neuroendocrine neoplasms in the United States (US) and the incidence is increasing (Dasari et al, 2017). Tumor grade and morphology predicts clinical outcome. Median overall survival is reported to be 16.2 years, 8.3 years, and 10 months in low-grade well NETs, intermediate-grade NETs, and NECs, respectively (Dasari et al, 2017).

Treatment options for NETs are limited. Current options include somatostatin analogues, mTOR inhibitor-everolimus, tyrosine kinase inhibitor-sunitinib, and peptide receptor radionuclide therapy (Pokuri et al, 2017).

About Seneca Therapeutics

Seneca Therapeutics was founded by Dr. Paul Hallenbeck to develop SVV-001. Seneca Therapeutics is also developing armed versions of SVV-001 that will selectively express gene product(s) that are inserted into the genome of SVV-001 and 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.