James A. Joyce, the Chairman and CEO of development-stage medical technology company Sigyn Therapeutics (OTCQB: SIGYD, SIGY), recently discussed the company’s opportunities, challenges, and decision-making processes in a letter to shareholders (https://ibn.fm/wGTqS). The company is currently focused on the development of four therapeutic candidates to address clearly defined limitations in global health:
Sigyn Therapeutics designed the ImmunePrep(TM) platform to enhance the performance of immunotherapeutic antibodies to treat cancer. Though highly valued, these antibodies are limited by poor delivery to cancer cell targets and as a result, most patients do not respond to therapy. Inhibiting the delivery of therapeutic antibodies are circulating decoys that display the binding site target of the antibody and can be highly prevalent in the bloodstream. As a result, a significant portion of an antibody dose can bind to circulating decoys instead of cancer cell targets.
“Amazingly, with more than 1,000 therapeutic antibodies being evaluated in human studies, there was no strategy to reduce the circulating presence of decoys that block the delivery of these drugs,” wrote Mr. Joyce. To fill this gap, Sigyn Therapy designed the ImmunePrep(TM) platform, whose implementation is based on a reverse decoy mechanism. This mechanism will leverage the use of therapeutic antibodies to create extracorporeal blood purification devices that extract antibody decoys from the bloodstream before the normal delivery of the same therapeutic antibodies.
“We believe this reverse decoy mechanism will increase the availability of antibodies to interact with their intended targets, and simultaneously, ImmunePrep(TM) devices are expected to extract disease targets from the bloodstream to further improve patient benefit,” explained James. “Our regulatory strategy is initially directed toward the development of ImmunePrep(TM) products that incorporate market-cleared antibodies already demonstrated to be safe and effective in human studies.”
Beyond ImmunePrep(TM), the company’s patent-pending ChemoPrep(TM) and ChemoPure(TM) are designed to enhance chemotherapy delivery and reduce toxicity, respectively. With recent scientific publications revealing that less than 2% of a chemotherapy dose is delivered to tumor cell targets, Sigyn Therapeutics recognized the need to create ChemoPrep(TM) to enhance chemotherapy delivery and the deploy ChemoPure(TM) post chemo delivery to reduce treatment toxicity and organ damage through the elimination of off-target chemotherapy from the bloodstream. “A reduction in chemotoxicity may also alleviate treatment-related fatigue and temper the long-term health consequences associated with chemotherapy administration,” stated Joyce.
ChemoPrep(TM) is designed to “reduce the circulating presence of tumor-derived exosomes (cancer exosomes) that interfere with chemotherapy delivery and contribute to treatment resistance.” Against this backdrop, Sigyn Therapeutics designed ChemoPrep(TM) to reduce of the circulating presence of exosomes prior to the infused delivery of chemotherapy to a patient. The company’s goal is to improve the delivery of chemotherapy and do so with lower doses, which would further reduce drug toxicity.
The company’s lead product candidate, Sigyn Therapy(TM), was created to address pathogen-associated inflammatory disorders that are not addressed with drug therapies. Its treatment indications include community-acquired pneumonia, drug-resistant viral and bacterial infections, endotoxemia, and sepsis, the leading cause of hospital deaths in the United States.
“We believe the successful clinical advancement of Sigyn Therapy(TM) could offer a strategic competitive advantage within the dialysis industry. As such, the treatment protocol of first-in-human studies calls for the enrollment of dialysis-dependent end-stage renal disease (“ESRD”) patients with endotoxemia and concurrent inflammation. These are untreatable conditions associated with cardiovascular disease, a leading cause of ESRD patient deaths,” explained Mr. Joyce.
Mr. Joyce also indicated that extending of lives of ESRD patients and reducing ESRD patient hospitalizations should be of considerable value to the dialysis industry. To support first-in-human studies of ESRD patients, the company has drafted an Investigational Device Exemption (“IDE”) for submission to the U.S. Food and Drug Administration (“FDA”).
“In closing, we have created an expansive lineup of therapeutic candidates with support from industry colleagues and the steadfast dedication of our team. A team that is not naïve to the challenges of advancing medical devices through FDA. A team focused on building an enduring organization whose therapies save lives,” concluded Joyce.
For more information, visit the company’s website at www.SigynTherapeutics.com.
NOTE TO INVESTORS: The latest news and updates relating to SIGY are available in the company’s newsroom at https://ibn.fm/SIGY
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