Developing the most revolutionary oncolytic immunotherapeutic candidates
to provide advanced targeted treatments for solid cancer
Our mission is to develop a pipeline of best-in-class oncolytic immunotherapeutics that are highly effective in treating cancer patients with solid cancers. At Seneca Therapeutics, we believe a cure for cancer is within our lifetime and we are working with urgency to see this promising possibility become a reality.
Seneca Therapeutics, Inc. (Seneca) is developing a pipeline of novel cancer agents using the nonpathogenic Seneca Valley Virus isolate 001 (SVV-001). The first product anticipated to be in later stage clinical trials in 2021 is SVV-001 itself. SVV-001 is targeted immunotherapy that selectively kills cancer cells expressing the SVV-001 receptor, TEM-8, and converts the tumor microenvironment from cold to hot. SVV-001 is expected to synergize with immune checkpoint inhibitors and other cancer agents to significantly benefit more cancer. patients.
Seneca’s lead asset is SVV, an oncolytic virus of the genus Seneca in the Picornaviridae family that is characterized by its ability to replicate selectively in certain human tumor cells (SVV-permissive cells), namely those that express TEM 8, the receptor of SVV. SVV-001 is non pathogenic in humans and animals.
SVV-001 and the Seneca genus was originally discovered in 2001 at Novartis Pharmaceuticals and further developed as a novel cancer therapeutic at Neotropix, Inc. SVV has been extensively tested in over 30 non-clinical cancer models, including immunotherapeutic settings, and in three clinical trials for various solid cancer namely neuroendocrine tumors such as carcinoid, small cell lung cancer and a variety of pediatric cancers. These trials confirmed the safety of intravenous dosing of SVV-001 and safety along with suggesting significant clinical benefit.
Combining these data and the inherent properties of this viral agent, the product/platform can be utilized as an intravenously or intratumorally administered oncolytic virus to treat SVV-permissive cancers. It is estimated that over 60 percent of all solid cancers has TEM 8 expressed on the surface of tumor cells. SVV kills tumor cells through replication in such cells resulting in apoptosis and cell lysis that in turn activates an anti-tumor response.
In addition, there is a high probability of synergistic anti-tumor activity when SVV is combined with immune modulators, cytokines and checkpoint inhibitors.
SVV is unique amongst members of the Picornaviradae family in that transgenes can be inserted into the SVV-001 genome and expressed specifically within the tumor. Transgenes can code for proteins to add additional safety over non-specific treatments and therapeutic benefit. Transgenes coding for immune-modulatory elements to further enhance the anti-cancer immune response as well as transgenes that code for proteins that eliminate negatively modulate elements within the tumor that suppress the anti-tumor response. Versions of SVV-001 are also being constructed to encode tumor antigens.
In the News
Seneca Therapeutics, Inc. Licenses Tumor Endothelial Marker 8
(TEM8) To Enable Better Patient Selection for SVV-001 Therapy
August 31, 2020: Seneca Therapeutics, Inc. a clinical stage biopharmaceutical company dedicated to the development of oncolytic immune therapeutics based on Seneca Valley Virus (SVV-001), announced today the company has licensed TEM 8 intellectual property from Memorial Sloane Kettering Cancer Center.
Seneca Therapeutics Board of Directors Appoints James M. Hussey as Chief Executive Officer and a Director of the Company
August 17, 2020: The Board of Directors of Seneca Therapeutics announced today the appointment of James M. Hussey as Chief Executive Officer and member of the Board of Directors.
Zachary Morris Joins Seneca Therapeutics Advisory Board
Seneca Therapeutics is pleased to welcome Zachary Morris, MD, PhD, to its Clinical Advisory Board. Dr. Morris will work closely with Dr. Paul Hallenbeck, founder and CEO of Seneca Therapeutic, Inc. as the company...
Dr. Paul Hallenbeck
Dr. Hallenbeck is the Founder, President and Chief Scientific Officer. He is a multiple award winning, serial entrepreneur, with 27 years in the biotechnology industry with expertise in all phases of cancer immuno-therapeutics R&D. As the sole founder of Neotropix, raised $30M in VC, then successfully led SVV (NTX-001) through IND approval, and completed several Phase I/II clinical trials, establishing an excellent safety record & compelling evidence of efficacy.
James M. Hussey
Jim Hussey is the Chief Executive Officer and a Pharmacist with an MBA who has spent the last 20+ years in pharma & biotech C-suite positions. He was most recently the acting US President at Morphosys. Mr. Hussey recently joined Seneca Therapeutics and will be strategizing business development partnership options for Seneca as well as securing the foundation needed to get to a Series B . Mr. Hussey will join Dr. Hallenbeck as his co-captain leading SVV-001 into clinical trials by the first quarter of 2021 and into a double digit ROI for investors via partnership or acquisition.
Dr. Sankar, MD, MPH, CCRP is the Chief Medical Officer and is President & Founder of SwanBio, LLC, a BD & Clinical Strategy consultancy firm that facilitates the translation of scientific discoveries into cancer therapeutics. An expert in global clinical development & regulatory strategies for therapeutic drugs; he has led numerous clinical trials in oncology (Genentech & Pharmacyclics) therapy ranging from breast, ovarian, pancreatic, liver, lung, and connective tissue tumors, to a range of hematological malignancies.
Sunil Chada, Ph,D is the Vice President of Research and Development Dr. Chada's drug development expertise includes antibodies, cell and gene therapies and small molecules for oncology, genetic diseases and immunotherapy. He is an expert in translating product concepts into clinical trials: >15 INDs; >20 Phase I-III. Dr. Chada is an adjunct faculty member in the Department of Experimental Therapeutics at MD Anderson Cancer Center at the University of Texas. He is also a special advisor to the chief scientific officer of MDACC Moonshots Initiative.
Dr. Aman Chauhan
Markey Cancer Center at The University of Kentucky
Dr Chauhan’s clinical interests include treating NETs, including carcinoid tumors, high-grade neuroendocrine carcinomas, and small carcinomas.
Dr. J. Randy Hecht
UCLA Jonsson Comprehensive Cancer Center
Dr. Randy Hecht’s research and clinical interests concern malignancies of the gastrointestinal tract. He participates in a range of activities and is particularly interested in translating laboratory findings into improved patient care.
Dr. Zachary Morris
Department of Human Oncology at The University of Wisconsin School of Medicine and Public Health
As a physician-scientist, his current clinical focus is on the treatment of patients with melanoma and soft tissue sarcomas. His independent translational research laboratory focuses on the mechanisms whereby radiation may enhance the response to immunotherapies.