Rapid antigen diagnostic antibody for differentiating SARS-CoV-2 Variants of Concern

Lead investigator: Scott Dessain, MD, PhD, Professor, Lankenau Institute for Medical Research (LIMR), Director, Center for Human Antibody Technology (CHAT) at LIMR

Unmet need

Efforts to control SARS-CoV-2 have been challenged by the spread of variant strains profoundly impacting clinical and epidemiological decision making. These Variants Being Monitored (VBMs) show increased transmissibility and/or disease severity, resistance to prior anti-SARS-CoV-2 immunity or antibody therapeutics, and the potential to evade diagnostic detection.

Methods are needed for point of care (POC) testing to identify these VBMs to protect health care facilities, congregate housing settings, transportation hubs, and high-risk occupational environments. Antigen-detection rapid diagnostic tests (Ag-RDTs) are ideal POC tests, but Ag-RDTs that recognize specific VBMs have not yet been implemented.

Current Ag-RDTs detect active virus infection but are not able to distinguish one variant from another. 

Opportunity

This invention uniquely allows for COVID-19 Antigen-Rapid Diagnostic Tests (Ag-RDTs) that provide information about the specific variant involved. This invention enables POC testing to rapidly identify dangerous Delta and non-Delta variants to protect individuals in high-risk settings. It will also help monitor epidemiological shifts among SARS-CoV-2 variants.

The invention uses the 2E8 monoclonal antibody to identify SARS-CoV-2 spike variants with the N501Y mutation. N501Y enhances SARS-CoV-2 virulence and is one of the most common and important variant-specific mutations.

Diagnostic testing companies can use the 2E8 mAb to achieve market differentiation by producing a variant specific Ag-RDT.

Unique attributes

• The crux of the invention is the 2E8 mAb, which distinguishes between SARS-CoV-2 spike variants with N501 and N501Y. As this is one of the most important mutations found in SARS-CoV-2 spike proteins expressed by medically important variants, the 2E8 mAb will have long-term utility for diagnosis of present and future SARS-CoV-2 strains. 
• Used in combination with other mAbs in an Ag-RDT, the 2E8 is a foundational mAb for distinguishing SARS-CoV-2 variants. For example, among 2E8 non-binders, the CB6 mAb further distinguishes the South African Variant (B.1.351) from UK (B.1.1.7) and Brazil (P.1).
• Methods for use of the 2E8 and CB6 mAbs in the diagnostic paradigm also are novel.

Clinical applications

In addition to its use as an Ag-RDT that recognizes specific Variants of Concern, there is a therapeutic potential. The 2E8 antibody has anti-viral activity. Investigators believe it could be given as a therapeutic for treatment of disease caused by N501 containing SARS-CoV-2. Importantly, the mAb could also be used as a lead to create an anti-pan-SARS-CoV-2 mAb, using antibody engineering to create a derivative that binds N501Y yet maintains its binding to N501. 

Stage of development

Ready for clinical use. Foundational data for use of the 2E8 in a variant-specific immunoassay have been obtained (manuscript submitted). LIMR can provide the mAbs as either purified IgG or DNA sequences validated for recombinant IgG expression. LIMR will assist licensees in adapting validated protocols for use in Ag-RDT formats.

Intellectual property

Patent application filed 2021 October regarding structural and methods claims on the use of the mAb in SARS-CoV-2 variant-specific diagnostic immunoassays.

Licensing opportunity

Lankenau Institute for Medical Research is seeking a licensee or licensees to commercialize the 2E8 mAb for diagnostic or therapeutic purposes.

Relevant publications

Submitted, October 2021

Contacts

Institutional contact: George C. Prendergast, PhD, LIMR President and CEO, 484.476.8475, [email protected]

L2C Partners contact: Merle Gilmore, MBA, 610.662.0940, [email protected]