Fully silent antibodies as true negative controls for in vitro and cell-based effector function assays
Antibody Analytics Ltd., a leading provider of antibody effector function characterisation and immunology research services, and mAbsolve, developers of a novel Fc silencing variant, today announced a licensing deal for mAbsolve’s Fc silencing technology. The agreement provides Antibody Analytics with access to the new STR Fc silencing platform for use as true negative controls in Fc receptor or C1q based assays.
Fc-mediated immune effector activities are an important part of an antibody’s natural function, but in many therapeutic antibodies these interactions are not desirable and can lead to catastrophic side effects. Many approaches to eliminate effector function have been developed, but none completely silence the unwanted binding to Fc gamma receptors. The new STR Fc silencing platform, developed by mAbsolve and described in a recent PLOS One article, delivers the only truly silent Fc mutations described to date. The technology therefore has the potential to improve the safety and efficacy of therapeutic antibodies and Fc fusion proteins.
Under the terms of this license agreement, Antibody Analytics will be able to generate STR variants of a customer’s antibody, or control antibody to the same target, to employ in a number of cell-based, in vitro and binding assays. The lack of effector function will provide their customers with a true negative comparator to their molecule, allowing reliable quantification of relative effector function of clinical candidates. Combining this with Antibody Analytics’ range of in house-produced Fc receptors, Antibody Analytics will be able to provide a suite of Fc binding and effector characterization services that will produce a comprehensive data package for regulatory filings.
“Antibody Analytics has supported multiple biosimilar and novel therapeutic antibody developers in their journey to the clinic. Demonstrating a lack of effector function has been a challenge, and assay designs are traditionally more complicated in an effort to convince regulators of an absence of functionality. Having this STR technology in our armory will allow us to streamline our assay design while providing stronger data for our customers to supply to regulators, this should expedite the process to approval.” said Andy Upsall, Managing Director at Antibody Analytics.
“mAbsolve is committed to improving the safety and effectiveness of therapeutic antibodies, and we strongly believe that STR technology can be of real benefit to a large proportion of antibody and Fc fusion proteins in development,” said Dr. Ian Wilkinson, Chief Scientific Officer at mAbsolve. “Our STR mutations provide a truly silent Fc region and so we look forward to working with Antibody Analytics to utilize this technology as a gold-standard negative control for comparison in assays being developed for their clients.”
With a solid foundation in antibody characterisation, gaining access to the STR technology is a natural extension of Antibody Analytics capabilities in this service areas and will be of significant interest to their antibody-focused developer customer base. This technology complements a number of innovations that Antibody Analytics have recently developed in house, including novel in vitro systems to model the tumour microenvironment and proprietary cell line development platforms to address challenges in the development of tumour antigen targeted therapies.
About Antibody Analytics, Ltd.
Antibody Analytics is dedicated to advancing drug development, with a special focus on biologics and immunomodulatory therapies. The company provides drug developers with in-depth, quality data to support new healthcare solutions. Acting as an extension of their Customer’s R&D and CMC departments, scientists turn to Antibody Analytics when they need support with designing and developing bespoke research methods. Antibody Analytics works with its clients on the most challenging of molecules and understand not only the underlying biology behind the complex environment in which the drugs are intended to function, but the need to deliver robust assay platforms to accelerate their drug development programs.
About mAbsolve Ltd.
mAbsolve founded in the UK by pioneers of therapeutic antibody development and engineering from both Oxford and Cambridge. We have experienced the clinical challenges caused by incomplete silencing of antibodies using LALA, aglycosylated or IgG4 variants. To address this we have developed a best-in-class solution for silencing of antibody effector function. Our STR technology is the only truly silent Fc.