Integral Molecular Reveals Widespread Off-Target Binding of Antibody-Based Drugs
Study Uncovers Alarming Findings
Integral Molecular, a pioneer in antibody discovery and characterization, has recently unveiled a groundbreaking study in the prestigious journal mAbs. The research sheds light on a concerning issue plaguing the pharmaceutical industry: up to one-third of antibody-based drugs exhibit nonspecific binding to unintended targets. This discovery poses a serious threat to patient safety, as off-target drug binding can lead to adverse events and, in some cases, even death.
The Impact of Off-Target Binding
Analysis of antibody off-target binding throughout various phases of clinical development suggests that this phenomenon is a leading cause of drug attrition. By conducting early specificity testing, developers can potentially enhance drug approvals and enhance patient safety.
Revolutionary Technology for Assessing Specificity
In the study led by Norden et al., researchers provide the first-ever empirical evaluation of antibody specificity by quantifying the prevalence of off-target binding across the drug pipeline. This comprehensive assessment was made possible through the use of Integral Molecular's cutting-edge Membrane Proteome Array™ (MPA). The MPA, a cell-based protein array representing the human membrane proteome, enables researchers to evaluate specificity and enhance drug safety.
Key Findings from the Study
Among the highlights of the study
- 18% of clinically administered antibody drugs exhibited off-target interactions.
- 22% of antibody drugs withdrawn from the market due to safety concerns displayed nonspecific binding.
- 33% of lead molecules tested demonstrated nonspecific binding, indicating a high likelihood of failure in later stages of development.
Redefining Antibody Specificity
These results challenge the conventional notion of absolute antibody specificity and emphasize the critical need for more rigorous testing protocols. Lead study author Dr. Diana Norden remarked, "Nonspecific drug binding can lead to adverse events or even death. The assumption of absolute antibody specificity is not entirely accurate. Novel technologies like the MPA offer a detailed assessment of antibody specificity, effectively reducing the risks associated with drug development."
About the Membrane Proteome Array™
Integral Molecular's Membrane Proteome Array™ stands as a premier technology for antibody specificity testing, trusted by numerous clients globally. With the ability to assess binding across approximately 6,000 proteins representing the complete human membrane proteome, the MPA delivers individual proteins in their biological conformation, ensuring precise results. The MPA's processes are ISO 9001 certified, and its specificity data has gained recognition from regulatory bodies worldwide, including the FDA.
About Integral Molecular
Integral Molecular (integralmolecular.com) leads the industry in developing and commercializing innovative technologies that enhance the discovery of therapeutics against challenging protein targets. With over two decades of expertise in membrane proteins, viruses, and antibodies, Integral Molecular's technologies have been integrated into the drug discovery pipelines of more than 600 biotech and pharmaceutical companies, driving the exploration of new treatments for cancer, diabetes, autoimmune disorders, and viral threats like SARS-CoV-2, Ebola, Zika, and dengue viruses.
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Integral Molecular, Inc.
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Phone: 215-966-6061
Reference: https://www.prnewswire.com/news-releases/up-to-one-third-of-antibody-drugs-are-nonspecific-study-shows-302249551.html