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SIWA has developed a proprietary humanized monoclonal antibody, SIWA318H (“318H”), that selectively targets, for immune system destruction, a biomarker on dysfunctional, disease-causing 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 (“SCs”), and (3) microbially-infected cells (viruses, bacteria and at least some parasites).

We have demonstrated that 318H binds to all three of these types of cell. Additional information can be found in the Data section of our website, which has images of several of these types of cell. We have a significant worldwide patent portfolio covering 318H and its applications.  

Our focus is on life-threatening cancers and related diseases with an unmet medical need (i.e., eligible for FDA Fast-tracking). Pancreatic cancer is our initial focus. We have worked with a major research institute pursuant to a sponsored research agreement to develop supporting data for 318H and its efficacy in treating pancreatic cancer. See “Pilot study to test SIWA318H in a humanized mouse xenograft model for pancreatic cancer,” in ‘Data’ for the results of our 318H efficacy study in immune humanized mice done for us by the institute. We are initiating an additional study with the institute, in which we will focus on confirming binding of 318H to various glioblastoma cells. See ‘Data‘ for an example some of our prior binding results of 318H on glioblastoma cells.

We also have entered into a sponsored research agreement with a major university to study renal cancers and other renal diseases. We are seeking licensees/partners to expedite development of 318H as a therapy in areas outside of our focus.

As 318H can deplete cancer cells as well as the SCs surrounding the cancer cells in the tumor micro-environment that stimulate, feed, and protect them, we believe 318H could become a comprehensive cancer therapy for all cancers as well as for stopping cancer progression, metastasis, and relapse (see, e.g., our in vivo triple negative breast cancer metastasis study in mice described in “Data”)

Charles River Laboratories, Inc. has completed an initial 318H Non-cGMP PK and toxicology study as well as a tolerability study in adult and juvenile non-human primates as support for filing an IND application with the FDA. No adverse effects were observed.

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. Our three principals, Lewis Gruber, Gabriela Rossi, PhD., and Misty Gruber, have over 75 years of combined experience in biotechnology/biopharmaceuticals.