Seneca Therapeutics, Inc. Announces Launch of a Novel Cancer Gene Delivery Platform based on SVV-001 Technology

PHILADELPHIA--()--Seneca Therapeutics, Inc. (“STI”), a clinical-stage biopharmaceutical company dedicated to the development of targeted oncolytic immunotherapeutics for cancer based on Seneca Valley Virus (SVV-001), announced today the launch of a novel Cancer Gene Delivery Platform based on SVV-001 technology. STI refers to these new entities as SVV-001 Armed Gene Constructs. STI has a wealth of data, including from three clinical trials that SVV-001 is amongst the most cancer selective oncolytic viruses. SVV-001 specificity to infect tumor cells is primarily due to the selective expression of eight (8) genes that are characterized in the recently announced SVV-001 Patient Selection Test. Chief among these genes is the receptor of SVV-001, namely Tumor Endothelial Marker 8 (“TEM8”). TEM8 is selectively expressed on the surface of tumor cells in a variety of tumor types.

STI has now demonstrated that genes to enhance cancer therapy can easily be inserted into SVV-001. The selectivity of expression of the genes inserted is equal to the selectivity of SVV-001 infection in tumor cells. STI has confirmed SVV-001 can deliver genes up to ~27 Kda or ~700 base pairs into tumors sensitive to SVV-001. Because SVV-001 is a natural, non-human virus, the manufacturing process to produce SVV-001 Armed Gene Constructs is much simpler, faster, and significantly less expensive than current virus or gene therapy vectors used in cancer gene delivery.

STI is in the process of producing and testing numerous SVV-001 Armed Gene Constructs carrying a variety of transgenes that are either immunostimulatory, aimed to reverse the immosuppressive environment in tumors, or express cancer neoantigens. Of particular interest is the delivery of cancer neo-antigens whereby a patient’s neo-antigens can be identified, synthesized and produced in just a few weeks. SVV is currently testing an SVV-001 Armed Gene Construct expressing the model antigen ovalbumin to characterize the ability to deliver human neo-antigens.

“Using SVV-001 as a viral vector for delivering genes to fight cancers expressing sensitivity to SVV-001 opens a very broad application for Seneca Valley Virus,” said Dr. Paul Hallenbeck, CSO and President of Seneca Therapeutics. “The potential to deliver single or multiple genes using SVV-001 via single dose IV infusion or multiple intra-tumoral injections is very exciting. We are especially excited about delivering a patient’s own neo-antigens using SVV-001 to fight cancer.”

The SVV-001 Patient Selection Test enables identification of patients who might benefit from SVV-001 therapy including SVV-001 Armed Gene Constructs. The announcement regarding the SVV-001 Patient Selection Test was made last week. The multiple dose IV infusion program for SVV-001 continues with data read out projected for early next year.

About Seneca Therapeutics

Seneca Therapeutics was founded by Dr. Paul Hallenbeck to develop SVV-001 related products. 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-001and 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.