SIWA Therapeutics, Inc., has announced positive results that support further development of its monoclonal antibody, 318H, as a broad-spectrum antiviral drug.
CHICAGO, IL — September 18, 2020 — SIWA Therapeutics, Inc., has announced positive results that support further development of its monoclonal antibody, 318H, as a broad-spectrum antiviral drug. In a new study done at a Biosafety Level 3 facility authorized to do COVID-19 testing, 318H was shown to bind to both Influenza A infected cells and SARS-CoV-2 infected cells (COVID-19 disease). Testing of other viruses is also in progress at the facility.
“Influenza A and COVID-19 disease have been observed to occur together,” said Lewis Gruber, CEO of SIWA Therapeutics. “There is concern that they may provide a combined threat of infection in the flu season.” 318H selectively targets cells having an abnormally high level of glycolysis (known as the Warburg effect) and oxidative stress. “Specifically, these are cancer cells, senescent cells, and most, if not all, virally infected cells. We have now demonstrated that 318H binds to all three kinds of cells,” Gruber adds. “By removing these dysfunctional cells, the ability of the body to fight these diseases is increased; if these cells are not removed, they could suppress the immune response and interfere with the regenerative ability of the body to repair itself. We have seen no adverse effects of removing these cells. We believe SIWA 318H has the potential to treat a wide variety of infectious diseases and to provide a powerful therapeutic to support patients who recover from COVID-19 but then suffer from long term complications,” shares Gruber.
SIWA’s main focus remains on treating life-threatening diseases with unmet medical need, specifically, aggressive cancers, including virally induced cancers and metastasizing cancers, that should qualify for FDA fast-tracking. SIWA is partnering with a major institution in pancreatic cancer on a 318H in vivo PDX pancreatic cancer in humanized mice. 318H uniquely reduces cancer cells as well as the senescent cells surrounding the cancer cells in the tumor microenvironment that stimulate, feed, and protect them. SIWA believes 318H could become a comprehensive cancer therapy.
Charles River Laboratories recently completed an in vivo 318H tolerability study in non-human primates as support for SIWA filing an IND application with the FDA. 318H was administered in multiple drug dosage amounts to animals of varying ages and sizes with no observable side effects. SIWA expects to receive the completed histological and pharmacokinetic analyses by the end of September 2020.
The tolerability/pharmacokinetics work should help to support a trial for the COVID -19 disease as well as for pancreatic cancer.
About SIWA Therapeutics, Inc.
SIWA’s proprietary humanized monoclonal antibody (“mAb”), 318H, selectively targets cells having an abnormally high level of glycolysis (known as the Warburg effect) and oxidative stress, specifically, cancer cells, senescent cells, and virally-infected cells. SIWA has shown that 318H binds in vitro to Influenza A-infected cells and SARS-CoV-2 infected cells; testing of additional viruses is in process. SIWA’s focus is primarily on treating aggressive cancers and other life-threatening diseases that should be eligible for FDA fast-tracking. SIWA is working with a major institution in pancreatic cancer. SIWA believes that 318H could become the first comprehensive cancer therapy as it uniquely reduces cancer cells as well as the SCs surrounding the cancer cells in the tumor microenvironment that stimulate, feed, and protect them. Charles River Laboratories has completed a tolerability study with 318H in non-human primates with no adverse effects observed. They will complete the pharmacokinetic study and analysis by the end of September.
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. Forbes named SIWA as one of 3 senolytics companies to watch (“Senolytic Therapies and the Quest to Cure Aging”). SIWA is actively seeking partnerships to advance SIWA 318 and other related technologies to broaden and accelerate its development pipeline.
More information is available at www.siwatherapeutics.com or follow CEO Lewis Gruber on LinkedIn.
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