SUNY Research Foundation

<p><br /></p>
<p><strong>The State University of New York - SUNY</strong></p>
<p>SUNY is the largest comprehensive university system in the United States. Encompassing 64 institutions that specialize in almost every imaginable field, SUNY includes research universities, academic medical centers, liberal arts colleges, community colleges, and colleges of technology. Its campuses are home to a network of centers and institutes that specialize in and contribute to a wide array of policy issues and fields of research.</p>
<p>At SUNY, we are solving problems, discovering solutions, creating knowledge, and improving our world.</p>
<p><strong>SUNY Research Foundation</strong></p>
<p>The Research Foundation for The State University of New York (SUNY Research Foundation) is the largest comprehensive university-connected research foundation in the country. It exists to serve the State University of New York by providing essential administrative services that enable SUNY faculty to focus their efforts on the education of students and the performance of life-changing research across a wide range of disciplines including medicine, engineering, physical sciences, energy, computer science, and social sciences.</p>
<p>The Research Foundation for SUNY provides talent, services, and technology that empower SUNY to research, innovate, and transfer discoveries that transform the world’s knowledge economy.</p>


<h1 id="background">Background</h1>
<p>Immunogenicity, the propensity of a product to elicit an immune response to itself or related structures, has the potential to reduce or eliminate the therapeutic benefit it is intended to provide, and may even lead to adverse clinical events. Because of its potential impact on safety and efficacy of therapeutic protein products, evaluation of a product’s immunogenicity is required by regulatory authorities (e.g. FDA and EMA). However, the predictive value of animal studies is low, and because immunogenicity can be based on product-, treatment- and patient-specific factors, evaluation of a product’s immunogenicity risk can be challenging to accurately assess prior to or even during clinical trials. In some cases, a product’s immunogenicity may not be fully known until after it has been approved and used in larger patient populations over extended periods of time. There is an unmet need for a reliable tool that can be used to more accurately predict both the likelihood and level of clinical immunogenicity prior to administration in human subjects.</p>
<h1 id="technology-overview">Technology Overview</h1>
<p>This University at Buffalo invention provides a tool that enables reliable measurement and prediction of a therapeutic protein’s immunogenic potential based on mechanism-based markers, including those specific to its route of administration, namely via the subcutaneous route. The tool provides a stimulation index as well as an indication of immune cell migratory potential, both of which can be measured against a control and compared to those of approved therapeutic proteins. To date, the tool has been demonstrated with five proteins, including adalimumab (Humira™), emicizumab (Hemlibra™) and the SARS-CoV-2 spike subunit 1 ‘S1’ protein, and the relative immunogenicity of each reflects that seen in the clinic.</p>
<h3 id="-stage-of-development-"><strong>Stage of Development</strong></h3>
<p><em>In vitro</em>.</p>
<h1 id="benefits">Benefits</h1>
<ul>
<li>Ability to predict clinical immunogenic response prior to administration in a human subject</li>
<li>Provides mechanistic insights into the driver(s) of immunogenicity</li>
<li>Can be generalized to a patient population or tailored to predict immunogenicity on a subject-by-subject basis</li>
</ul>
<h1 id="applications">Applications</h1>
<ul>
<li>Biomedical Research</li>
<li>Drug and Vaccine Development</li>
<li>Personalized Medicine</li>
</ul>
<h1 id="opportunity">Opportunity</h1>
<p>Available for licensing or collaboration.</p>
