Rapid diagnostics (disposable devices) to detect and/or mitigate antibody (Ab) responses against protein-based therapies.
The immune system is capable of mounting antibody (Ab) responses against proteins or peptides (large molecules containing amino acid building blocks), and this has been widely utilized for vaccination against pathogens. Well-know examples are vaccines based on immune responses against the spike protein of the SARS-CoV-2 virus that causes COVID-19. In the case of vaccines, Ab responses are desirable.
Most approved therapeutic drugs are either small molecules or proteins (biotherapeutics). Unlike vaccines, Ab responses against biotherapeutics are undesirable consequences of the treatment, as they may negatively impact efficacy and/or safety. Unintended anti-biotherapeutic Ab incidence has caused interruption of development for many drugs, and is also a looming postmarketing concern. Various factors may trigger those unwanted antibody responses, such as patient genetics, impurities, protein aggregation, amino acid mutations and/or other protein modifications. Preclinical biotherapeutic immunogenicity predictions based on T-cell epitopes are not reliable, and clinical data suggest an interplay between tolerance and Ab responses. In addition, typically immunogenicity is not monitored after product approval.
Vaccines and biotherapeutics such as monoclonal antibodies represent growing multibillion-dollar markets.
There is an unmet need for in vitro rapid diagnostics (disposable devices) for point-of-care detection of Abs against biotherapeutics, to enable risk assessment and precision medicine. Existing assays for anti-biotherapeutic Ab detection require preparation of serum or plasma, sample handling, multiple steps, trained operators, and often take days to provide results. Another problem is that it is not possible to integrate results from those diverse assays to obtain valid conclusions, and immunogenicity of biotherapeutics used for the same application cannot be compared. ConquerAb’s proprietary rapid diagnostics can allow standardization of detection of Abs against a plethora of biotherapeutics currently marketed or in development, immunogenicity comparisons, and timely selection of therapeutic agents more likely to be effective.
Monitoring Ab status prior to and after vaccination has also often been uncommon, due to the inexistency of practical rapid diagnostics for point-of-care or at home testing. ConquerAb’s technology addresses this gap as well.
We have devised innovative diagnostics (disposable devices) for rapid point-of-care or at-home testing of anti-biotherapeutic Abs, in less than ten minutes, and using one drop of blood. These diagnostics do not require trained users, enable immunogenicity comparisons for biotherapeutics used for the same application, and stratification of Ab-positive and Ab-negative patients - precision medicine. It allows utilization of patient data generated at different point-of-care facilities (“big data”) and proprietary databases to guide rational drug development. In addition, the technology can be used to monitor patient immune status before and after vaccination. ConquerAb Inc. is the assignee for 3 granted U.S. patents and also for other U.S. and international patent applications, trademarks and service marks (e.g. CONQUERAB®).
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