Current Therapeutic Limitation

Antibody-based immunotherapies (“monoclonal antibodies”, “mAbs” or “mAb”) have revolutionized the treatment of incurable diseases, including cancer.  Despite their clinical advancement, treatment benefit is often suboptimal as just a fraction of infused antibodies will reach their intended therapeutic target. 

Mechanistically, mAbs are designed to lock onto a specific protein that resides on the surface of a therapeutic target.  However, non-target molecules that display the same surface protein are empowered to decoy and sequester infused antibodies from reaching their therapeutic target. The presence of circulating mAb decoys is associated with poor treatment outcomes and remains a notable limitation of antibody-based immunotherapies.

Sigyn Solution

ImmunePrepTM is a development-stage commercialization platform for antibody-based immunotherapies and their corresponding biosimilars. The platform allows for the creation of therapeutic device candidates to enhance the delivery of market-approved or clinical-stage monoclonal antibodies. 

“Selective Elimination of Antibody Decoys”

More specifically, ImmunePrepTM allows for a monoclonal antibody to be the active component of an adjunct device that eliminates circulating decoys that would subsequently block the targeted delivery of the same antibody. The dual-use of the same antibody insures the selective elimination of circulating molecules with the structural capability to interfere with mAb delivery.   The goal of this reverse-decoy mechanism is to optimize the availability of mAbs to interact with their therapeutic targets. Concurrently, the ability of therapeutic targets to escape antibody interactions would be diminished.  Thus, countering a mechanism associated with drug resistance. 

ImmunePrepTM devices are designed for deployment on blood processing systems that can be located within the infusion centers where patient delivery of therapeutic antibodies occurs.  The infusion of mAb therapy is intended to occur immediately after an ImmunePrepTM device has depleted mAb decoys from the bloodstream. It is anticipated that ImmunePrepTM devices may also be investigated for potential clinical use when administered during other phases of an antibody treatment regimen.

 “Informative Biomarker Collection from the Entire Circulatory System”

In many cases, circulating targets captured by an ImmunePrepTM device may also be critically informative biomarkers of disease progression and drug resistance. These biomarkers can be eluted from the device post-treatment for laboratory analysis.  Additionally, the quantification of therapeutic targets captured within an ImmunePrepTM device and no longer circulating in a recipient patient establishes a datapoint to reinforce treatment performance.

“A Strategy to Deploy Market-Approved or Clinical-Stage Antibodies”

The ImmunePrepTM platform establishes a candidate strategy to create adjunct devices that incorporate 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.

The World Health Organization’s (WHO) International Agency for Research on Cancer projects the market for therapeutic monoclonal antibodies will grow from $208.68 billion (USD) in 2023 to $566.72 billion (USD) in 2032.  ImmunePrepTM establishes a candidate strategy to optimize the delivery of these drug agents. 

If demonstrated to be clinically effective, ImmunePrepTM products would overcome a therapeutic limitation in healthcare and likely provide a competitive advantage to organizations focused on the commercialization of therapeutic antibodies.

ImmunePrepTM is associated with a provisional patent submission entitled: “DEVICES FOR ENHANCING THE ACTIVITY OF THERAPEUTIC ANTIBODIES” that has been filed with the United States Patent and Trademark Office (“USPTO”).