Integral Molecular Awarded $2.7 Million to Advance the Membrane Proteome Array™ Towards FDA-Qualification as a Drug Development Tool

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Nov 19, 2024, 08:13 ET

PHILADELPHIA, Nov. 19, 2024 /PRNewswire/ -- Integral Molecular, a leader in antibody discovery and characterization, has been awarded $2.7 million by the NIH Commercialization Readiness Pilot (CRP) Program. This funding will support FDA-qualification of Integral Molecular's Membrane Proteome Array™ (MPA), a next-generation technology that provides critical safety data required for Investigational New Drug (IND) filings of biologic drugs. The MPA is a cell-based protein array designed for specificity testing of antibody-based therapeutics and the only platform that screens for specificity using native protein conformations.

Learn how the Membrane Proteome Array™ enables the precise identification of off-target binding interactions, a primary determinant of drug safety

Integral Molecular's recently published data show that up to one-third of antibody drugs have non-specific binding, and suggests that off-target binding is a significant cause of drug failure (Norden et al., 2024). Non-specific binding was detected even for drugs currently on the market that were previously screened using tissue cross-reactivity (TCR), an older and less precise technology. The new NIH funding will support efforts to validate the MPA as a more accurate alternative to TCR.

"We thank the NIH for their ongoing commitment to advancing drug safety tools. Their continued support—from early-stage grants to this advanced-stage CRP award—has been essential in making our Membrane Proteome Array the industry standard for in vitro specificity testing of biologics."

– Benjamin Doranz, CEO, Integral Molecular

MPA processes are ISO 9001 certified, and the technology is under FDA review for qualification as a Drug Development Tool (DDT). Once qualified within its context-of-use, DDTs can be relied upon in IND, NDA, or BLA applications without needing the FDA to reconsider and reconfirm their suitability. The newly awarded CRP funds will support the company's ISO 9001 commitment to quality assurance, continuous process improvement, and the MPA's pathway to qualification.

About Integral Molecular

Integral Molecular (integralmolecular.com) is the industry leader in creating transformative technologies that advance the discovery of therapeutics against difficult protein targets. With 20+ years of experience focused on membrane proteins, viruses, and antibodies, Integral Molecular's technologies have been integrated into the drug discovery pipelines of over 600 biotech and pharmaceutical companies to help discover new therapies for cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses.

Press Contact
Integral Molecular, Inc.
Soma Banik, PhD, Director of Public Relations
215-966-6061
[email protected]
www.integralmolecular.com

SOURCE Integral Molecular