Lonza’s Synaffix and BigHat Biosciences Team Up on Machine Learning-Designed ADCs

Synaffix, a Lonza company, announced on Oct. 30, 2024 that it has licensed its antibody-drug conjugate (ADC) technology to BigHat Biosciences (BigHat), a US-based biotech company which will combine the Synaffix technology with its machine learning (ML) antibody design platform. Through the collaboration, the companies aim to develop a new ADC pipeline program.

Under the agreement, BigHat will receive target-specific access to Synaffix’s late clinical-stage, site-specific ADC technology platform. This platform enables transformation of antibodies into proprietary, best-in-class ADC products. Lonza’s acquisition of Synaffix in June 2023 (1) means that BigHat also gains access to Lonza’s DNA-to-investigational new drug (IND) ADC offering. This DNA-to-IND offering enables drug developers to receive all necessary current good manufacturing practice (CGMP)/non-CGMP ADC batches leading up to the first clinical trial. The service is housed under a single quality system that encompasses all critical development and manufacturing activities, including antibody production, bioconjugation, and drug product filling.

“The ADC space continues to develop and evolve, and our collaboration with BigHat exemplifies the continued strength and appeal of our best-in-class ADC technology. We are excited to be at the forefront of next-generation ADC R&D by joining forces with BigHat and its AI [artificial intelligence]/ML-enabled antibody discovery and development platform. BigHat is the ideal partner for Synaffix to collaborate with. We look forward to supporting BigHat with every step in the ADC development and manufacturing process under the Lonza umbrella,” said Peter van de Sande, head of Synaffix, in a company press release.

Milliner, which is BigHat’s AI/ML-powered antibody design platform, works by integrating a synthetic biology-based high-speed wet lab with state-of-the-art ML technologies into a full-stack antibody discovery and engineering platform. This platform is used to engineer antibodies with more complex functions and better biophysical properties. Using this approach reduces the difficulty of designing antibodies and other therapeutic proteins when developers look to tackle conditions ranging from chronic illness to life-threatening disease. The platform also offers significant speed to reaching candidate discovery and validation.

“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. 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) [Switzerland] 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,” Jean-Christophe Hyvert, president, Biologics, Lonza, said in the release.

Through this collaboration with Synaffix/Lonza, BigHat intends to advance its next-gen ADC program. BigHat’s ADC program is at the IND-enabling stage and is on track to be the company’s first clinical-stage program. According to the press release, BigHat’s next-gen ADC was optimized using the Milliner platform. It is designed for maximum payload delivery to tumor cells and with optimal drug-like-properties. Incorporating Synaffix's ADC technologies, such as GlycoConnect, HydraSpace, and toxSYN, BigHat expects to further improve the safety and efficacy of its next-gen ADC.

"BigHat is leveraging our AI-driven antibody design platform, Milliner, to develop advanced biologics that provide safer and more effective treatments for difficult-to-treat cancers. We are excited to combine Synaffix’s conjugation and linker-payload technologies with our custom-designed antibody to create a next-generation ADC for patients with high unmet medical need," said Mark DePristo, CEO, BigHat Biosciences, in the release.

Reference

1. Lonza. Lonza to Acquire Synaffix and Strengthen Antibody-Drug Conjugates Offering. Press Release. June 1, 2023.

Source: BigHat Biosciences