- Listen to our founder and CEO, Lewis Gruber discuss SIWA and 318H!
- In The News: Supertrends
- Press Release: SIWA Therapeutics Grows Leadership Team with Appointment of Gabriela Rossi, Ph.D.
- In The News: Startup.info Interview
- In The News: BIOSPACE
- In The News: 1000 Longevity Leaders
- BIO Digital 2020
- In The News: SIWA Joins the fight against COVID-19
- In the News: SIWA Featured on Chicago Business Journal
Therapies capable of attacking cells with our SIWA-identified marker represent an innovative approach in the treatment of cancer metastasis, neuro-degenerative, auto-immune, and infectious diseases.
– Lewis S. Gruber, CEO
SIWA has developed a proprietary humanized monoclonal antibody, 318H, that selectively targets a biomarker on cells exhibiting a combination of: (a) an abnormally high level of glycolysis (Warburg effect) and (b) oxidative stress. Cells with our marker include specifically (1) cancer cells, (2) senescent cells, and (3) microbially-infected cells (viruses, bacteria and at least some parasites). 318H binds to all three cell types, including cells infected by SARS-CoV-2 (COVID-19) and Influenza A. We have developed a worldwide patent portfolio covering 318H and its applications.
Our initial focus is on life-threatening gastrointestinal (“GI”) disease, including cancer, for which there is an unmet medical need (i.e., eligible for FDA Fast-tracking). Because 318H can uniquely reduce cancer cells as well as SCs surrounding the cancer cells in the tumor micro-environment that stimulate, feed, and protect them, we believe 318H should become a comprehensive cancer therapy. We expect to file our first IND in late 2021 jointly with a major institution that is collaborating with us in pancreatic cancer/cachexia. Because disorders of the GI tract often result in renal injury, we are working with another institute on a specific renal application as a possible second indication.
In Vitro Studies. We have shown 318H binding in vitro to all types of cancer cells from aggressive cancers, e.g. human pancreatic cancer and gliomas as well as to human SCs from numerous tissues, including e.g., Alzheimer’s and Parkinson’s diseases, osteoarthritic cells, and diseased renal cells. We also have shown 318H binding to cells infected by SARS-CoV-2 (COVID-19) and Influenza A. We are seeking a licensee/collaboration partner for infectious disease.
In Vivo Studies. (1) We first showed that 318M (a 318H mouse homolog) statistically significantly (a) reduced SCs and (b) promoted muscle growth in normally aged very old mice, in each case, back to the level of young mouse controls. (2) A second study showed that 318M statistically significantly inhibited cancer metastasis with trending toward reduced primary tumor growth (mouse 4T1 triple negative breast cancer model). Charles River Laboratories, Inc. completed an in vivo 318H tolerability/pharmacokinetic study in non-human primates in preparation for filing an IND application with the FDA. No adverse effects have been observed in any of our in vivo studies.
In February 2020, SIWA was named a “key player” in Anti-Aging Drugs by the MIT Technology Review in its prestigious list of the 10 Breakthrough Technologies of 2020. In September 2018, Forbes named SIWA as one of 3 senolytics companies to watch (“Senolytic Therapies and the Quest to Cure Aging”). Our three principals, Lewis Gruber, Gaby Rossi, PhD., and Misty Gruber, have over 75 years of experience in biotechnology/biopharmaceuticals.