Synaffix, a Lonza company focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs), licensed its ADC technology to BigHat Biosciences which will combine Synaffix technology with its machine learning (ML) antibody design platform for the development of a new ADC pipeline program.

BigHat will receive target-specific access to Synaffix’s late-clinical stage, site-specific ADC technology platform, which enables the transformation of antibodies into proprietary ADC products. BigHat will also gain access to Lonza’s DNA-to-IND offering which reportedly enables drug developers to receive all necessary cGMP/non-cGMP ADC batches leading up to the first clinical trial under a single quality system encompassing all critical development and manufacturing activities, including the production of the antibody, bioconjugation, and drug product filling.

BigHat’s AI/ ML-powered antibody design platform, Milliner™, integrates a synthetic biology-based high-speed wet lab with ML technologies into a full-stack antibody discovery and engineering platform, to engineer antibodies with more complex functions and better biophysical properties, says a BigHat official, who adds that this approach reduces the difficulty of designing antibodies and other therapeutic proteins to tackle conditions ranging from chronic illness to life-threatening disease, while also speeding up candidate discovery and validation.

Critical to advancing BigHat’s next-gen ADC program

The collaboration with Synaffix/Lonza is instrumental to advancing BigHat’s next-gen ADC program, which is at IND-enabling stage and is on track to be BigHat’s first clinical stage program, according to Peter van de Sande, head of Synaffix. BigHat’s next-gen ADC was optimized on BigHat’s Milliner platform for maximum payload delivery to tumor cells and optimal drug-like-properties, noted van de Sande, who explained that the incorporation of Synaffix’s GlycoConnect,™ HydraSpace®, and toxSYN®, ADC technologies is intended to further improve the safety and efficacy of BigHat’s next-gen ADC.

“We are pleased to announce this collaboration with BigHat for its next-gen ADC molecule, which shows how drug developers can benefit from a fully integrated suite of services across our biologics division,” said Jean-Christophe Hyvert, president, biologics, Lonza.

“The Lonza network has continued to adapt to the evolving ADC landscape, including the recent addition of a highly potent vial fill capability at our Stein (CH) facility. This dedicated ADC drug product capacity expansion completes our offer for comprehensive, end-to-end development and manufacturing services for ADCs, simplifying the path from DNA-to-IND and beyond for our customers.”

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