SIWA Therapeutics has developed SIWA318H™, preparing to enter human clinical trials.
It targets cells damaged by oxidative stress, which is common in cancer and aging-related diseases.
SIWA Therapeutics developed SIWA318H™, a humanized monoclonal antibody that targets a biomarker on cancer cells and other damaged/dysfunctional cells. SIWA318H™ works by stimulating the immune system’s ability to fight off harmful pathogens like bacteria, viruses, and cancer cells. The targeted biomarker indicates oxidative damage and is associated with cancer cells, as well as senescent cells, which play a key role in the development and progression of age-related diseases. Senescent cells also promote cancer progression and metastasis.
SIWA318H™ is an innovative immunotherapy that uses a dual-targeting mechanism to combat cancer and aging-related conditions.
SIWA318H™ targets diseased or dysfunctional cells to remove cells that cause or contribute to disease conditions. Its potential therapeutic benefits help with chronic kidney disease, osteoarthritis, aging related muscle wasting (sarcopenia), and infectious diseases. It has also shown effectiveness in targeting influenza and COVID-19-infected cells.
In February 2020, SIWA Therapeutics earned recognition as a “key player” in the Anti-Aging Drugs sector by MIT Technology Review, securing a place on its prestigious “10 Breakthrough Technologies of 2020” list.
TGen, the Translational Genomics Research Institute, a part of City of Hope, is an Arizona-based nonprofit that conducts groundbreaking medical research to improve lives.
TGen analyzes the genetic foundations of complex diseases, including cancer, neurological disorders, infectious diseases, and rare childhood conditions.
TGen received NIH grant funding to study the SIWA318H™ monoclonal antibody therapy in an advanced pancreatic cancer mouse model. The research evaluates the benefits of combining a mouse-compatible version of SIWA318H™ with current chemotherapy and immunotherapy treatments.
The study is designed to demonstrate the value of the SIWA318H ™ antibody as an adjunct therapy for pancreatic cancer patients.
Charles River Laboratories accelerates research and drug development with essential products and services that transform possibilities into breakthroughs. From discovery through early development and safe manufacturing, they provide comprehensive solutions that help pharmaceutical, biotech, government, and academic teams bring new therapies to patients faster.
Founded in 1947 as a single laboratory in Boston overlooking the Charles River, it has grown into a global strategic partner with over 130 facilities across 20 countries. Our scientific expertise and comprehensive capabilities have contributed to over 80% of FDA-approved drugs in the past five years, establishing them as the partner of choice for nonclinical drug research and development.
Charles River Laboratories completed initial non-cGMP tolerability pharmacokinetic and toxicology studies of SIWA318H™ and tolerability assessments in both adult and juvenile non-human primates to support their FDA Investigational New Drug (IND) application.
Importantly, no adverse effects of the SIWA318H™ treatment were observed in any of these studies.
SIWA Therapeutics’ co-founders, Lewis and Misty Gruber, bring valuable experience in forming successful animal health partnerships. Their track record includes developing the commercially successful Sexcel technology through a collaboration between their previous venture and Genus ABS.
The Grubers have demonstrated a consistent ability to build strategic industry relationships, having earlier established a genomics partnership with American Cyanamid through another company they founded.
Complementing their business achievements, Misty Gruber has contributed to scientific knowledge in animal health through peer-reviewed research published in Poultry Science, adding academic credibility to their entrepreneurial expertise.
SIWA Therapeutics is led by a seasoned executive team with extensive industry expertise:
Lewis Gruber, Gabriela Rossi, Ph.D., and Misty Gruber.
Collectively, they bring over 75 years of experience in biotechnology and biopharmaceutical development to their leadership roles at SIWA.
Lewis Gruber co-founded SIWA Therapeutics after serving as director and interim CEO of a company that develops natural killer cell products. That research involves the natural killer cells that implement ADCC, which led to the actual SIWA318H technology.
In 2000, Gruber co-founded Arryx, Inc., and served as its CEO until 2005, when it was acquired by a publicly traded company. Under his leadership, Arryx received prestigious recognitions, including the World Economic Forum Technology Pioneer award (2005), and was named among Red Herring’s Top 100 Innovators (2004).
From 1994 to 2000, Gruber was CEO and director of Hyseq, Inc., where he led the company through 1997’s largest biotech IPO and secured over $90 million in collaborative partnerships. He is the inventor of all SIWA intellectual property and has co-invented numerous other patented technologies.
In April 2020, Gruber was recognized on the Aging Analytics Agency’s list of 1000 Longevity Leaders. Before becoming an entrepreneur, he worked as a patent attorney specializing in biotechnology. He holds a J.D. and an M.S. in biology.
Contact: lsgruber@siwacorp.com
Misty Gruber co-founded SIWA Therapeutics after serving as a corporate finance expert at Dykema Gossett PLLC, where she was a member and Co-Chair of the biotechnology group. During her 29-year legal career, she represented various clients including issuers, investors, underwriters, and venture capital companies in transactions across North and South America, Europe, and Asia.
Beyond her legal expertise, Gruber was licensed as a CPA for several years, bringing valuable financial acumen to her role. She was also a co-founder of Arryx, Inc. and served as an initial director of Hyseq, Inc., demonstrating her long-standing involvement in biotechnology ventures.
Gruber holds a J.D., a B.S., and an M.S. in biology. In her leadership role at SIWA, she combines legal knowledge with scientific understanding.
Contact: msgruber@siwacorp.com
Dr. Gabriela Rossi completed her undergraduate and doctoral education in Córdoba, Argentina, earning her Ph.D. in Infectious Disease and Immunology in 1997. Her distinguished postdoctoral training included fellowships at several prestigious institutions, including the National Institutes of Health (NIH), the National Cancer Institute, and the Iowa Cancer Research Foundation.
Throughout her career, Dr. Rossi has developed extensive expertise in immunology and diverse animal models used in biomedical research. Her scientific contributions have been published in peer-reviewed journals and presented at numerous national and international conferences.
Dr. Rossi brings valuable process development experience to SIWA Therapeutics, having worked with cGMP biological materials from early clinical trials through late-stage development. Her comprehensive background includes expertise in clinical study design and bridging laboratory research with therapeutic applications.
Contact: gabyrossi@siwacorp.com
SIWA has adopted a model wherein we engage in contract and sponsored research work with top tier institutions such as TGen/City of Hope as well as with top Cancer Research Organizations. This model has allowed SIWA to retain all intellectual property rights while minimizing overhead. We believe this has allowed SIWA to be extremely efficient with our funds.