PRECISION MEDICINE
Rapid diagnostics (disposable devices) to detect and/or mitigate antibody (Ab) responses against protein-based therapies.
Rapid diagnostics (disposable devices) to detect and/or mitigate antibody (Ab) responses against protein-based therapies.
Patient immune systems can mount antibody (Ab) responses against therapeutic protein drugs (biotherapeutics). Ab responses against biotherapeutics other than vaccines are undesirable consequences of the treatment, and they often abrogate the biotherapeutic efficacy. Those Abs may also negatively impact safety, causing adverse events varying in severity from mild infusion reactions to anaphylactic shock. Preclinical biotherapeutic immunogenicity predictions based on T-cell epitopes are not reliable. In addition, typically immunogenicity has not been monitored after product approval. Unintended Ab incidence has caused interruption of development of many biotherapeutics, and is also a looming postmarketing concern regarding efficacy and/or safety. Rapid diagnostics for detection of unwanted Abs, and to compare immunogenicity of biotherapeutics are needed.
Biotherapeutics used for treatment of arthritis, cancer, multiple sclerosis, diabetes and many other diseases are a growing multibillion-dollar market.
There is an unmet need for in vitro rapid diagnostics (disposable devices) for point-of-care and/or at home 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 with their results. 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 can addresse 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 15 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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