Lonza's Synaffix Collaborates with BigHat Biosciences on the Development of a Machine Learning-Designed ADC
Lonza's Synaffix has licensed its ADC technology to BigHat Biosciences following successful preclinical studies. The collaboration combines BigHat's AI/ML-powered antibody design platform, Milliner™, with Synaffix's GlycoConnect™, HydraSpace® and toxSYN® ADC technologies to develop next-generation ADCs. Through Lonza's acquisition of Synaffix, BigHat gains access to Lonza's comprehensive DNA-to-IND ADC development and manufacturing services. The partnership aims to advance BigHat's next-gen ADC program, which is currently at IND-enabling stage and set to become BigHat's first clinical stage program.
Synaffix di Lonza ha concesso in licenza la propria tecnologia ADC a BigHat Biosciences a seguito di studi preclinici di successo. La collaborazione combina la piattaforma di design di anticorpi alimentata da AI/ML di BigHat, Milliner™, con le tecnologie ADC di Synaffix, GlycoConnect™, HydraSpace® e toxSYN®, per sviluppare ADC di nuova generazione. Grazie all'acquisizione di Synaffix da parte di Lonza, BigHat ottiene accesso ai servizi completi di sviluppo e produzione ADC di Lonza, dalla DNA all'IND. L'obiettivo della partnership è quello di far progredire il programma ADC di nuova generazione di BigHat, attualmente in fase di abilitazione all'IND e destinato a diventare il primo programma clinico di BigHat.
Synaffix de Lonza ha licenciado su tecnología ADC a BigHat Biosciences tras estudios preclínicos exitosos. La colaboración combina la plataforma de diseño de anticuerpos impulsada por IA/ML de BigHat, Milliner™, con las tecnologías ADC de Synaffix, GlycoConnect™, HydraSpace® y toxSYN®, para desarrollar ADCs de próxima generación. A través de la adquisición de Synaffix por parte de Lonza, BigHat obtiene acceso a los servicios integrales de desarrollo y fabricación de ADC de Lonza, desde DNA hasta IND. La asociación tiene como objetivo avanzar en el programa de ADC de nueva generación de BigHat, que actualmente se encuentra en la etapa de habilitación de IND y está en camino de convertirse en el primer programa clínico de BigHat.
론자의 시나픽스는 성공적인 전임상 연구를 통해 빅햇 바이오사이언스에 ADC 기술을 라이센스했습니다. 이 협업은 빅햇의 AI/ML 기반 항체 디자인 플랫폼인 Milliner™과 시나픽스의 GlycoConnect™, HydraSpace® 및 toxSYN® ADC 기술을 결합하여 차세대 ADC를 개발합니다. 론자가 시나픽스를 인수함으로써, 빅햇은 론자의 포괄적인 DNA-to-IND ADC 개발 및 제조 서비스에 접근합니다. 이 파트너십의 목표는 현재 IND 승인 단계에 있는 빅햇의 차세대 ADC 프로그램을 발전시키는 것으로, 이는 빅햇의 첫 임상 단계 프로그램이 될 것입니다.
Synaffix de Lonza a licencié sa technologie ADC à BigHat Biosciences suite à des études précliniques réussies. La collaboration associe la plateforme de conception d'anticorps alimentée par l'IA/ML de BigHat, Milliner™, aux technologies ADC de Synaffix, GlycoConnect™, HydraSpace® et toxSYN®, pour développer des ADC de nouvelle génération. Grâce à l'acquisition de Synaffix par Lonza, BigHat a accès aux services complets de développement et de fabrication d'ADC de Lonza, de l'ADN à l'IND. L'objectif de ce partenariat est d'avancer le programme ADC de nouvelle génération de BigHat, qui est actuellement en phase de préparation à l'IND et doit devenir le premier programme clinique de BigHat.
Lonza's Synaffix hat seine ADC-Technologie an BigHat Biosciences lizenziert, nachdem erfolgreiche präklinische Studien durchgeführt wurden. Die Zusammenarbeit vereint BigHats KI/ML-gestützte Antikörperdesign-Plattform, Milliner™, mit Synaffix' Technologien GlycoConnect™, HydraSpace® und toxSYN®, um ADCs der nächsten Generation zu entwickeln. Durch die Übernahme von Synaffix durch Lonza erhält BigHat Zugang zu Lonzas umfassenden DNA-zu-IND ADC-Entwicklungs- und Fertigungsdiensten. Ziel der Partnerschaft ist es, das ADC-Programm der nächsten Generation von BigHat voranzutreiben, das sich derzeit in der IND-fähigen Phase befindet und das erste klinische Programm von BigHat werden soll.
- Strategic licensing agreement expands Synaffix's ADC technology reach
- Access to Lonza's end-to-end ADC development and manufacturing capabilities
- Project already at IND-enabling stage, indicating advanced development status
- None.
- Commercial license to Synaffix technologies follows a series of successful initial preclinical proof of concept studies
- Collaboration underscores Lonza's commitment to helping customers deliver innovative new therapies to patients by offering a comprehensive service offering for differentiated ADCs
- BigHat's artificial intelligence (AI)/machine learning (ML)-powered antibody design platform, Milliner™ was used to design a highly differentiated antibody that was paired with Synaffix's GlycoConnect™, HydraSpace® and toxSYN® ADC technologies to generate a next-gen ADC
Under the terms of the agreement, 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, best-in-class ADC products. As a result of Lonza's acquisition of Synaffix in June 2023, BigHat will also gain access to Lonza's end-to-end ADC offering. This DNA-to-IND offering enables drug developers to seamlessly 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 state-of-the-art ML technologies into a full-stack antibody discovery and engineering platform, to engineer antibodies with more complex functions and better biophysical properties. 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 massively speeding up candidate discovery and validation.
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. BigHat's next-gen ADC was optimized on BigHat's Milliner platform for maximum payload delivery to tumor cells and optimal drug-like-properties. The incorporation of Synaffix's GlycoConnect™, HydraSpace® and toxSYN® ADC technologies is intended to further improve the safety and efficacy of Big Hat's next-gen ADC.
Peter van de Sande, Head of Synaffix, said: "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/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."
Jean-Christophe Hyvert, President, Biologics, Lonza, added: "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) 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."
Mark DePristo, CEO at BigHat Biosciences, commented: "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."
About Synaffix
Synaffix B.V. is a biotechnology company that enables ADC product candidates using its clinical-stage, site-specific ADC technology platform based on GlycoConnect™, HydraSpace® and toxSYN® technologies, that together enable any company with an antibody to develop proprietary best-in-class ADC products under a single license from Synaffix.
The Synaffix platform enables a rapid timeline to clinic due to the established supply chain of technology components. Synaffix holds granted patents to its technology. The business model of Synaffix is target-specific technology out-licensing, as exemplified through its existing deals with ADC Therapeutics, Mersana Therapeutics, Shanghai Miracogen (acquired by Lepu Biopharma), Innovent Biologics, Kyowa Kirin, Genmab, Macrogenics, Amgen, Hummingbird Biosciences, Chong Kun Dang Pharma, ABL Bio, and SOTIO Biotech.
Synaffix was fully acquired by Lonza in June 2023.
About The Synaffix ADC Platform Technology
Synaffix's proprietary ADC technology platform consists of GlycoConnect™, GlycoConnect™ High DAR Technology, HydraSpace®, and toxSYN® technologies. These technologies are aimed at enabling best-in-class ADCs from any antibody, with significantly enhanced efficacy and tolerability.
GlycoConnect™ clinical-stage conjugation technology exploits the native antibody glycan for site-specific and stable payload attachment and is tunable to DAR1, DAR2 or DAR4 formats. The extension of GlycoConnect™ with High DAR Technology enables ADCs with high drug loading (6, 8 and above), while retaining high drug substance homogeneity and therapeutic index. HydraSpace® clinical-stage compact and highly polar spacer technology is designed to further enhance therapeutic index, particularly with hydrophobic payloads. toxSYN® linker-payload platform spans key, validated MOAs for ADC product development. This includes potent topoisomerase 1 inhibitor (SYNtecan E™), DNA damaging agents (SYNeamicin D™, SYNeamicin G™ and SYN-PNU™), ⍺-Microtubule (SYNtansine™) and β-Microtubule (SYNstatin E™ and SYNstatin F™) inhibitors as well as several unlaunched proprietary linker-payloads that were generated through the ongoing innovative efforts of the Synaffix R&D team.
The newest proprietary linker-payload, "SYN-PNU™" is part of the established and expanding toxSYN™ linker-payload portfolio. SYN-PNU™ represents (based on pre-clinical models) a significantly potency-attenuated and better tolerated version of PNU-159,682, to enable enhanced administered dose levels and competitive therapeutic properties versus ADCs prepared using the original molecule. The reference compound (PNU-159,682) is metabolite of the anthracycline Nemorubicin and represents a highly potent DNA topoisomerase II inhibitor.
The combination of these three technologies provides developers with a "one stop" and easy-to-use ADC technology platform, allowing any antibody developer to develop its own proprietary ADC and any ADC developer to expand its pipeline further and increase its competitive position.
About Lonza
Lonza is one of the world's largest healthcare manufacturing organizations. Working across five continents, our global community of around 18,000 colleagues helps pharmaceutical, biotech and nutrition companies to bring their treatments to market. United by our vision to bring any therapy to life, we support our customers with a combination of technological insight, world-class manufacturing, scientific expertise, process excellence and innovation. Our work enables our customers to develop and commercialize their therapeutic discoveries, allowing their patients to benefit from life-saving and life-enhancing treatments.
Our business is structured to meet our customers' complex needs across four divisions: Biologics, Small Molecules, Cell & Gene, and Capsules & Health Ingredients. Our company generated sales of
Follow @Lonza on LinkedIn
Follow @LonzaGroup on X
About BigHat Biosciences
BigHat Biosciences is a biotechnology company with an AI/ML-guided antibody discovery and development platform, capable of engineering antibodies with more complex functions and better biophysical properties. By using its ML-powered antibody design program to iteratively improve antibodies through sequential design-build-test cycles. The system measures the biophysical properties and impact on disease activity using cell-based or other functional assays, which replicate in vivo disease processes.
BigHat is a Series B biotech outside
View original content:https://www.prnewswire.com/news-releases/lonzas-synaffix-collaborates-with-bighat-biosciences-on-the-development-of-a-machine-learning-designed-adc-302295242.html
SOURCE Synaffix B.V.
FAQ
What technologies are being combined in the Lonza-BigHat collaboration for ADC development?
What stage is BigHat's next-gen ADC program currently in?
What services will Lonza (LZAGY) provide to BigHat through this collaboration?
When did Lonza acquire Synaffix?
