SIWA Therapeutics, Inc. is a pre-clinical stage company with:
- A first-in-class humanized monoclonal antibody (“mAb”), SIWA 318H, that selectively targets both senescent cells (“SCs”) and cancer cells;
- In vitro results showing SIWA 318H binding to, e.g. cancer cells from human pancreatic cancer and gliomas as well as to human SCs from numerous other tissues, including e.g., Alzheimer’s and Parkinson’s diseases, ALS and osteoarthritic cells;
- In vivo results showing SIWA 318M (a SIWA 318H mouse homolog) reduces SCs in normally-aged, very old mice and reduces cancer metastasis lung foci (triple negative breast cancer model);
- A significant worldwide patent portfolio.
SIWA 318 selectively targets both cancer cells and senescent cells (“SCs”) for destruction by the immune system. Both cell types have: (a) an abnormally high level of glycolysis (known as the Warburg effect in cancer) and oxidative stress and (b) a SIWA-identified cell surface antigen (an oxidative stress biomarker that is a side product of glycolysis) that is targeted by SIWA 318H. We believe SIWA 318H can become the first comprehensive cancer therapy as it uniquely reduces cancer cells as well as the SCs surrounding the cancer cells in the tumor micro-environment that stimulate, feed and protect them. Reducing SCs also can lead to regeneration of damaged tissues and combat frailty in recovery.
SCs accumulate with aging, damage and/or exposure to stress and have a causative role in age-related dysfunction and degenerative diseases including, e.g. cancer, diabetes and many neurodegenerative diseases ‒ they also secrete substances that interfere with the normal functions of other cells and contribute to inflammation. Despite having senescence in their name, SCs are associated with stress/damage at all ages, not only in old age. It should be noted that along with an increased accumulation of SCs, cancer incidence rises exponentially in later life (persons over 65 account for 70% of cancer deaths) and in fact, age is the greatest risk factor for cancer and cancer is one of the leading causes of morbidity and mortality.
We first showed in normally aged (20+mos) CD-1 mice that treatment in vivo with SIWA 318M (mouse homolog of our mAb) statistically significantly (a) reduced SCs back to the level of young mouse controls and (b) regenerated muscle tissue. We then showed in vivo that treatment with SIWA 318M statistically significantly (30%+) reduced metastasis in a 4T1 triple negative breast cancer model. In that study, we also observed trending toward smaller tumor size. No adverse effects of treatment were observed.
We are working with researchers at major university institutes in pancreatic cancer (study in humanized mice) and in prostate cancer. We have begun exploratory studies on renal disease with a potential animal health partner. While working with these groups, we are focusing internally on completing toxicology studies which are prerequisites to filing of an IND.