Sigyn Therapeutics, Inc. disclosed that it has submitted a provisional patent application entitled: " DEVICES FOR ENHANCING THE ACTIVITY OF THERAPEUTIC ANTIBODIES" to the United States Patent and Trademark Office ("USPTO"). Associated with this patent submission, the Company further disclosed that a trademark application to register ImmunePrep has also been filed with the USPTO. ImmunePrep is a development-stage commercialization platform for antibody-based immunotherapies and their corresponding biosimilars.

The platform is designed to permit the potential creation of selective plasma depletion devices that enhance the delivery of therapeutic antibodies without increasing drug toxicity. Therapeutic antibodies are market-cleared to treat a variety of indications, including but not limited to Alzheimer's disease, autoimmune disorders, and cancer. However, patient response to these therapies is often optimal as just a small portion of infused antibodies reach their intended therapeutic target.

In many cases, infused antibodies are bound by drug decoys that display the antibody's antigen binding site on their surface. As a result, these decoys are empowered to bind and sequester antibodies from being delivered to their therapeutic targets (such as cancer cells). ImmunePrep is designed to allow for a monoclonal antibody to be the active component of a selective plasma depletion device that preemptively eliminates bloodstream decoys that would subsequently block the infused delivery of the same antibody.

The mechanistic objective of this pre-treatment strategy is to increase the availability of antibodies to interact with their intended therapeutic targets without increasing drug toxicity. Concurrently, the ability of therapeutic targets to evade antibody interactions would be diminished. The Company believes that the ImmunePrep platform establishes a novel strategy to create selective plasma depletion therapies that incorporate either market-approved or clinical-stage monoclonal antibodies.

As of June 30, 2022, the Umabs antibody database reported 162 antibody therapies to be market-approved by at least one regulatory agency, including 122 approvals in the US, followed by 114 in Europe, 82 in Japan and 73 in China. In December 2022, the Antibody Society reported nearly 1200 therapeutic antibodies to be in clinical studies.