Seneca Therapeutics Reports Late Breaking Information on SVV-001 from the American Association for Cancer Research’s 2021 Annual Meeting

(Business Wire) Philadelphia, PA— April 12, 2021 — Seneca Therapeutics, Inc. (“STI”), a clinical-stage biopharmaceutical company dedicated to the development of targeted oncolytic immunotherapeutics based on Seneca Valley Virus (SVV-001), announced today the poster presentation of Seneca Therapeutics’ abstract titled “Oncolytic Seneca Valley Virus (SVV) overcomes resistance to checkpoint inhibitor therapies in neuroendocrine and melanoma murine models expressing the receptor for SVV”. Key points from the presentation:

1)     SVV-001 demonstrates the ability to turn cold tumors hot;

2)     Intratumoral administration of SVV-001 in combination with a checkpoint inhibitor demonstrates up to six fold increase in anti-tumor response over SVV-001 alone or check point inhibitor therapy alone;

3)     SVV-001 specifically targets, infects and kills TEM8 positive cancer cells.  No cell killing was observed in normal cells;

4)     RNA seq data confirm up regulation of genes known to stimulate an immune response;

A randomized Phase III clinical study comparing SVV-001 administered IT in combination with Opvido and Yervoy compared to Opdivo and Yervoy alone in TEM8 positive neuroendocrine tumors and neuroendocrine carcinomas is planned to begin later in 2021.  STI is also developing SVV-001 for intravenous use in TEM8 positive tumors as well as developing SVV-001 to deliver armed viruses to TEM8 positive tumor cells.    

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 to selectively express gene product(s) that are inserted into the genome of SVV-001 and create additional anti-tumor effects.

LATE BREAKING POSTER PRESENTATION FROM THE AMERICAN ASSOCIATION FOR CANCER RESEARCH 2021 ANNUAL MEETING

Seneca Therapeutics Expands Product Pipeline Adding Six New SVV-001 Armed Constructs Targeting TEM 8 Expression

(Business Wire) Philadelphia, PA— February 8, 2021 — Seneca Therapeutics, Inc. (“STI”), a clinical-stage biopharmaceutical company dedicated to the development of targeted oncolytic immunotherapeutics based on Seneca Valley Virus (SVV-001), announced today the expansion of its R&D pipeline with six new armed gene therapy/oncolytic constructs directed against important cancer targets and indications. STI also announced an SVV-001 Armed Construct program developing precision medicine constructs expressing patient-specific Neo-antigens.  Each of these new gene therapy technologies uses SVV to exclusively target cancer cells with TEM 8 expression.  Normal cells lack significant expression of TEM 8 and are therefore not infected by SVV-001, and so the armed transgene will not express in normal cells. Studies in multiple human tumor types indicates TEM 8 expression is an adverse indicator of long-term survival and is associated with cancer metastasis.  STI intends to develop each combination as an IV product, taking advantage of the multiple IV dosing program currently underway at the company:

  • SVV-012- SVV+ Anti PD-L1 – “Addition of a checkpoint inhibitor is designed to enhance the CD8+ T-cell response against tumors”

  • SVV-024 – SVV+ Enhanced IL-2 Gene – “This construct is designed to bind IL-2 receptors to activate the immune response in tumors without activating CD25 and thereby avoid toxicities observed with the IL-2 protein”

  • SVV-037 – SVV+ CXCL-9 – “This construct is designed to express the chemokine CXCL-9 in the tumor microenvironment and promote recruitment of immune cells into treated tumors”

  • SVV-044 – SVV+ TGF-beta decoy – “This construct is designed to block TGF-beta signaling in tumors and avoid immunosuppression”

  • SVV- 058 SVV+ Nitroreductase – “This nitroreductase construct is designed to function as a prodrug and convert cytotoxic metabolites selectively in the tumor microenvironment”

  • SVV- 069 – SVV+ IL-2/IL-15 Fusion Protein - “Vectors delivering IL-2/IL-15 agonists are designed to improve immune cell trafficking and infiltration into tumors and provide both T-cell and NK-cell signals”

Each of these products either has been or is being produced in STI’s SVV platform.  Animal studies for each product are anticipated to begin in 2Q21. 

The SVV-001 Armed Construct for Neo-antigens program plans to use patient specific neo-antigens to take advantage of the rapid two-week development cycle for SVV-001 Armed Constructs.  

“While SVV itself has many distinct advantages over other forms of cancer therapy, chief among them is the exquisite cancer cell specificity of both SVV replication and the expression of a transgene, making SVV a unique multi-modal platform”, said Dr. Paul Hallenbeck, Ph.D. Founder and President of STI. 

About Seneca Therapeutics

Seneca Therapeutics, Inc. was founded by Dr. Paul Hallenbeck to develop SVV-001 related products.  STI is also developing armed versions of SVV-001 to 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.

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Contact:

Paul Hallenbeck James Hussey

phallenbeck@senecatherapeutics.com jhussey@senecatherapeutics.com

www.senecatherapeutics.com