ADCs are monoclonal antibodies engineered to go unnoticed, delivering cytotoxic drugs to cells expressing the antigen target. Cancer therapy has become the most prevalent application area, with 30 ADCs currently in clinical trials.
Successful development of an ADC requires optimization of several elements, including the antibody, the potency of the cytotoxic drug, the stability of the linker, the site of conjugation and the stoichiometry of the resulting adducts.
Innate Pharma, a biopharmaceutical company based in France, specializes in the development of new monoclonal antibodies targeting cancer and inflammatory diseases.
Its long history in the generation of these antibodies positions them to enter the field of ADCs, where they have developed a unique coupling technology. Early on in the development process, Innate Pharma recognized the need for reliable methods to evaluate the stability of these ADC products in aqueous liquid form. Long-term stability was critical for validating the technology concept for clinical applications.
As such, Innate Pharma looked to Enzo Life Sciences to provide assays for screening the stability and aggregation properties of their ADCs.
As a global provider of innovative tools for biotherapeutics development, Enzo Life Sciences offers products for the entire biopharmaceutical pipeline, from drug discovery through downstream processing.
Working together, Enzo and Innate Pharma validated the use of the ProteoStat Aggregation Assay and ProteoStat Thermal Shift Assay for ADC discovery research.
Among the findings, it was observed that the greater the number of units of the anti-mitotic and anti-tumor agent coupled to the monoclonal antibody and the more lipophilic the linker, the higher the aggregation propensity. In comparison studies using existing and novel ADCs from Innate Pharma, the ProteoStat dye consistently predicted the propensity for aggregation as well as physical and chemical stability of the conjugates.
This work confirms Innate Pharma’s coupling technology as an excellent platform for the development of stable, robust ADC products. Moreover, the results demonstrate the use of Enzo’s ProteoStat dye as a unique tool which can be broadly applied to aid in the development of ADCs, improving the optimization and scale-up of viable candidates.
"This agreement helps to broaden the application of a key product line in our Drug Discovery portfolio, a rapidly growing segment of our business," said Barry Weiner, President of Enzo Biochem, Inc.
"We have seen a proliferation of drug candidates in the cancer area, and have positioned Enzo to support both drug design efforts as well as with companion diagnostic development. We are therefore excited to have this opportunity to work with Innate Pharma, as their success in developing first-in-class therapeutic antibodies makes them an ideal partner for understanding and addressing drug development challenges."
Jérôme Tiollier, Executive Vice President and Chief Development Officer of Innate Pharma, added, "Our collaboration with Enzo Life Sciences has been mutually beneficial. Their novel ProteoStat dye for detection of protein aggregates provides a new screening technology for enhanced lead optimization."