PHILADELPHIA—Integral Molecular, the leader in antibody discovery against membrane proteins, has been accepted into the U.S. Food & Drug Administration (FDA)’s ISTAND pilot program. This program supports Innovative Science and Technology Approaches for New Drugs and was created to expand the drug development tool types listed in the 21st Century Cures legislation. A major goal of the pilot program is to qualify these tools, thus facilitating regulatory review by allowing them to be used in regulatory (IND, NDA or BLA) applications without needing the FDA to reconsider and reconfirm their suitability.
Despite their reputation for ‘exquisite specificity’, antibodies and antibody-based therapies, such as CAR-T cells, frequently demonstrate unexpected off-target binding. Integral Molecular’s Membrane Proteome Array (MPA) for antibody specificity and safety profiling intends to address ICH-FDA’s in vitro testing recommendations to assess unintended binding of monoclonal antibodies that can result in safety and toxicity issues.
The MPA is one of the largest collections of membrane proteins used for specificity profiling of antibody-based therapeutics, with over 6,000 native-conformation membrane proteins encompassing nearly the entire human membrane proteome. This technology is intended to be compatible with numerous biotherapeutic modalities, including monoclonal antibodies, bispecifics, and CAR-T therapeutics.
“We are thrilled to be working with the FDA’s ISTAND program,” said Benjamin Doranz, CEO of Integral Molecular. “We share the FDA’s interest in developing in vitro technologies to better assess the safety of antibody drugs at an earlier and less costly stage of development.”
FDA has posted a statement on this LOI acceptance to the ISTAND Pilot Program: https://www.fda.gov/drugs/drug-safety-and-availability/cder-and-cber-accept-first-submission-istand-pilot-program
About Integral Molecular
Integral Molecular (integralmolecular.com) is the industry leader in developing and applying innovative technologies that advance the discovery of therapeutics against difficult protein targets. With 20 years of experience focused on membrane proteins and antibodies, Integral Molecular’s technologies have been integrated into the drug discovery pipelines of over 400 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.