Sigyn Therapeutics Inc. (OTCQB: SIGY)

Sigyn Therapeutics Inc. (OTCQB: SIGY) is a development-stage medical technology company headquartered in San Diego, California. The company's therapeutic candidates include Sigyn Therapy™ to address pathogen-associated inflammatory disorders, the ImmunePrep™ platform to enhance the performance of immunotherapeutic antibodies, ChemoPrep™ to improve the delivery of cancer chemotherapy and ChemoPure™ to reduce the toxicity of chemotherapy.

Sigyn created each of these technologies with two prerequisites in mind: 1) they must offer to overcome a clearly defined limitation in healthcare, and 2) their successful clinical advancement would offer a potential competitive advantage to established therapeutic organizations.

Sigyn Therapy™

The company is advancing Sigyn Therapy™ to treat pathogen-associated inflammatory disorders that are not addressed with FDA approved drugs. Candidate treatment indications include community-acquired pneumonia, drug-resistant virus and bacterial infections, endotoxemia and sepsis, which is the leading cause of hospital deaths in the United States.

The technology has the following attributes and capabilities.

• Sigyn Therapy™ incorporates a formulation of adsorbent components that have more than 200,000 square meters (~50 acres) of surface area on which to adsorb and remove therapeutic targets from the bloodstream.
• In vitro studies have demonstrated the ability of Sigyn Therapy™ to eliminate life-threatening pathogen and inflammatory disease targets from human blood plasma. In these studies, 12 relevant targets, including viral pathogens, bacterial toxins and inflammatory cytokines, were validated. Subsequent animal studies were completed at the University of Michigan.
• Sigyn Therapy™ is highly efficient, as the entire circulatory system of a patient can pass through the device ~15-times during a four-hour treatment.
• To allow for broad deployment, Sigyn Therapy™ is designed for use on the established infrastructure of dialysis and continuous renal replacement machines already located in hospitals and clinics around the world.

First-in-human studies of Sigyn Therapy™ plan to enroll dialysis dependent end-stage renal disease (ESRD) patients with endotoxemia and concurrent inflammation, which are highly prevalent and associated with increased mortality in the ESRD population. There are more than 550,000 individuals with ESRD in the United States, which result in approximately 85 million dialysis treatments being administered each year.

The ImmunePrep™ Platform

Immunotherapeutic antibodies to treat cancer are among the most valued assets in global medicine. However, these drugs suffer from a severe limitation: they are poorly delivered to cancer cell targets, and, as a result, a majority of patients do not respond to therapy.

The Sigyn team recognized that just a small fraction of an antibody dose reaches its cancer cell target, yet a significant portion of the same dose can be sequestered by circulating decoys that display the target (antigen) binding site of the antibody. In response, Sigyn designed the ImmunePrep™ platform to leverage the use of therapeutic antibodies to create extracorporeal blood purification devices that sweep antibody decoys from the bloodstream prior to the subsequent infusion (normal delivery) of the same therapeutic antibody.

The company believes its reverse decoy mechanism will increase the availability of antibodies to interact with their intended disease targets, and, simultaneously, the devices will also extract disease targets from the bloodstream to further improve patient benefit.

The opportunity to enhance the performance of therapeutic antibodies is significant. Consider that Pfizer's $43 billion acquisition of Seagen Inc. and Amgen's $27.8 billion acquisition of Horizon Therapeutics were the highest valued M&A deals of 2023. In both cases, transaction values were driven by market-cleared antibody assets.

Perhaps more revealing were the values placed on clinical-stage (pre-revenue) therapeutic antibody candidates. In this regard, consider Merck's $10.8 billion acquisition of Prometheus Biosciences and Roche's $7 billion acquisition of a clinical-stage antibody from Roivant Sciences.

In the backdrop of these M&A transactions, the immune checkpoint antibody Keytruda (Merck) became the world's best-selling (non-vaccine) drug in 2023, with anticipated revenues of ~$24 billion.

ChemoPrep™ and ChemoPure™

Recent scientific publications have reported that only 1% of chemotherapy is delivered to the tumor cell targets of cancer patients. In response, the Sigyn team designed ChemoPrep™ to overcome a delivery limitation of the most commonly administered drug to treat cancer.

The company is developing ChemoPrep™ to reduce the circulating presence of tumor-derived exosomes (tumor exosomes), which interfere with chemotherapy delivery. High concentrations of tumor exosomes in the bloodstream correspond with poor treatment outcomes, whereas low concentrations of tumor exosomes correspond with more favorable outcomes. As compared to non-cancer subjects, exosome populations are reported to be 10x to 500x higher in the bloodstream of cancer patients. Based on these factors, the company believes there is a compelling scientific rationale to reduce the circulating presence of tumor exosomes prior to chemotherapy administration.

Inversely, the Sigyn team recognized that if 99% of chemotherapy was missing its target, then there was a need to eliminate off-target chemotherapy from the bloodstream to reduce toxicity and limit organ damage. This factor led to the design of ChemoPure™ to reduce treatment toxicity by reducing the presence of off-target chemotherapy from the bloodstream. The company believes that a reduction in chemotoxicity may also alleviate treatment-related fatigue and potentially temper the long-term health consequences associated with chemotherapy administration.

Management Team

James A. Joyce is Co-Founder, Chairman and CEO of Sigyn Therapeutics. He has more than two decades of public company CEO and corporate board leadership experience and is an inventor or co-inventor of 20 pending or issued patents, including those underlying ImmunePrep, ChemoPrep, ChemoPure and Sigyn Therapy. Previously, he was founder and CEO of Aethlon Medical, a therapeutic technology company that he built from a start-up to a Nasdaq-traded company. Under his leadership, Aethlon developed the first medical device to receive two breakthrough device designations from the FDA. Mr. Joyce graduated from the University of Maryland.

Annette Marleau, Ph.D., is Chief Scientific Officer at Sigyn Therapeutics. Prior to joining the company, she was Chief Technology Officer at Immunicom Inc. and Director of Research at Aethlon Medical Inc. Additionally, she is an inventor on pending and issued patents underlying blood purification therapies targeting cancer, inflammatory disorders and life-threatening infectious diseases. She holds a Ph.D. from Western University, an M.S. from the University of Guelph and a B.S. from the University of Waterloo in Canada.

Jerry DeCiccio, CPA, is CFO at Sigyn Therapeutics. He has more than 40 years of financial industry experience. Previously, he was CFO/COO at Intech Electromechanical, CFO/COO at GTC Telecom, CFO at Incomnet Communications and President at Cerebain Biotech Corp. He also served in senior financial roles at Parker Hannifin Corp., Waste Management Inc. and Newport Corp. He earned a bachelor's degree in accounting and business administration from Loma Linda University and an MBA in finance and systems technology from the University of Southern California.