Sigyn Therapeutics releases letter to shareholders

Sigyn Therapeutics announced the release of a shareholder letter authored by Chairman and Chief Executive Officer, Jim Joyce. “Over the past eighteen months, we set the stage for first-in-human studies of Sigyn Therapy and quietly built a foundation for therapeutic devices to enhance the performance of cancer therapies…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 don’t respond to therapy… In response, we designed the ImmunePrep platform. Mechanistically, ImmunePrep is intended 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 of the same therapeutic antibody. We believe this reverse decoy mechanism will increase the availability of antibodies to interact with their intended targets and simultaneously, ImmunePrep devices are expected to extract disease targets from the bloodstream to further improve patient benefit… ChemoPrepTM & ChemoPure. Recent scientific publications have reported that only 1% of chemotherapy is successfully delivered to the tumor cell targets of cancer patients. In response, we began to investigate strategies to overcome the delivery limitations of the most commonly administered drug to treat cancer. Inversely, we recognized if 99% of chemotherapy was missing its therapeutic target, then there was an additional need to remove off-target chemotherapy from the bloodstream to reduce toxicity and limit organ damage. These thoughts, along with some pre-clinical data evolved into a patent submission entitled: “Systems and Methods to Enhance Chemotherapy Delivery and Reduce Toxicity.” This pending patent underlies our therapeutic system comprised of ChemoPrep which is intended to enhance the tumor site delivery of chemotherapy and ChemoPure to reduce its toxicity. …We are advancing Sigyn Therapy to treat pathogen-associated inflammatory disorders that are not addressed with FDA approved drugs. Our candidate treatment indications include community-acquired pneumonia, drug-resistant viral & bacterial infections, endotoxemia, and sepsis, the leading cause of hospital deaths in the United States…Our business and clinical strategy to enroll ESRD patients was established with feedback from dialysis industry executives. Furthermore, we leveraged our industry relationships to craft the protocol of our first-in-human clinical studies, to establish multiple clinical site locations, and identify our principal investigators. To support our proposed study, we have drafted an Investigational Device Exemption for submission to the FDA that calls for the enrollment of 12-15 ESRD patients with endotoxemia and concurrent inflammation… 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 naive to the challenges of advancing medical devices through FDA. A team focused on building an enduring organization whose therapies save lives.”