Formation Bio Subsidiary Licenses Oral Dual JAK/SYK Inhibitor Gusacitinib to Sanofi in Deal Worth Up to $632 Million

On June 23, Formation Bio, an AI pharmaceutical company focused on accelerating drug development, announced that its subsidiary Libertas Bio had licensed Gusacitinib, an oral dual JAK/SYK inhibitor, to Sanofi. Sanofi will explore the drug's potential in new indications. According to the agreement, the deal could be worth up to €545 million (approximately $632 million), including upfront payments, milestone payments, and low-to-mid double-digit royalties based on future sales.

Gusacitinib was acquired by Formation Bio from Asana BioSciences at the end of 2022 and is currently in Phase III clinical trials. This transaction with Sanofi brings Gusacitinib into its next development phase. Sanofi will leverage its global expertise in drug development and commercialization to explore its potential in new indications.

This authorization agreement is a continuation of the long-term cooperation between the two parties.

Formation Bio, formerly known as TrialSpark, focuses on acquiring high-potential clinical assets and accelerating their development using AI. By collaborating with other drug development companies, its AI platform optimizes the entire drug development process, including clinical trial design and data analysis, to enhance the automation efficiency of the R&D workflow.

In October 2022, Sanofi signed a three-year contract with TrialSpark (now Formation Bio) to leverage the company's shared data and technical expertise in developing AI tools, with a joint commitment to advancing cutting-edge therapies in highly underserved areas.

In May 2024, Formation Bio, together with OpenAI, the developer of ChatGPT, agreed to assist Sanofi in integrating artificial intelligence into its drug development processes, including creating customized AI agents and models. Subsequently, Sanofi co-led Formation Bio's $372 million Series D funding round a month later, with the company stating that the funds would be used to expand its clinical pipeline.

This transaction is built on the foundation of a long-term partnership between the two parties, further strengthening the commitment of both companies to advance promising therapies through innovative technologies and excellent science.

Gusacitinib, the core asset of this transaction, is an oral dual JAK/SYK inhibitor that can simultaneously inhibit two proteins, JAK and SYK. These two proteins are involved in immune and inflammatory signaling cascades and play key roles in various autoimmune diseases.

The JAK-STAT signaling pathway is one of the most important signaling pathways in the human body, playing a crucial role in key biological processes such as cell proliferation, differentiation, apoptosis, and immune regulation. SYK (spleen tyrosine kinase), on the other hand, plays a central role in B-cell receptor signaling and inflammatory responses. Theoretically, simultaneously blocking these two pathways may produce a synergistic effect, offering a new option for patients who respond poorly to traditional single-target drugs.

The drug was originally developed by Asana BioSciences. In November 2022, Formation Bio (then named TrialSpark) acquired gusacitinib from Asana and established the subsidiary Libertas Bio to lead its development. Rapid progress followed the acquisition. Currently, Formation Bio has advanced gusacitinib into Phase III clinical trials for the treatment of chronic hand eczema.

Notably, Sanofi does not seem to continue its development in this disease area but will explore the potential of gusacitinib in a previously unstudied new indication through Phase I research.

"The deal with Sanofi pushes gusacitinib into a brand-new stage of development. Sanofi will leverage its global expertise in drug development and commercialization to explore the potential of this drug in new indications," Formation Bio said in a press release.

Sanofi spares no effort in investing in AI drug development.

In 2022, Sanofi opened an Artificial Intelligence Center of Excellence in Toronto, aiming to identify, develop, and expand innovative solutions. In the same year, Sanofi entered into a collaboration with Exscientia worth up to $5.2 billion in total, to jointly develop up to 15 novel small-molecule drugs related to oncology or immunology. This collaboration was not only one of the largest deals in the AI drug discovery field that year but also marked Sanofi's deep exploration into leveraging AI technology to accelerate drug discovery and optimization.

In 2023, Sanofi announced its "All in AI" strategy, with Paul Hudson aiming to make this MNC the first pharmaceutical company to be driven by AI on a large scale. In April this year, Sanofi also announced an over $1.8 billion collaboration with biologics expert Earendil Labs, focusing on advancing two bispecific antibodies for immunology indications, showcasing its ambition to leverage AI technology for innovative treatment solutions in the field of immunology.

In fact, besides Sanofi, multinational corporations (MNCs) are highly enthusiastic about collaborating with AI-driven pharmaceutical companies. Nearly every large pharmaceutical company has publicly announced partnerships with AI firms. Compared to the earlier years when cooperation mainly focused on basic compound screening, the current collaborations have become much more diverse. They now encompass various aspects of drug discovery, including target identification, candidate compound screening, molecular optimization, and clinical data management.

Among them, many cooperative projects are aimed at major disease areas with unmet medical needs, such as oncology, neurology, immunology, and inflammatory diseases. In addition, multiple collaborations mentioned utilizing multimodal databases and integrating molecular data for drug target identification, reflecting that multi-omics data-driven AI drug discovery is becoming a trend. Specialized target identification for mRNA drugs and gene-editing therapies also demonstrates that AI is becoming a means to assist in the development of new treatment methods. There are also involvements in using AI to streamline the clinical trial data management and review process, showing that AI is extending to the back-end of clinical development.

From their respective perspectives, MNCs generally have a positive outlook on the application of AI in drug development, viewing it as a key tool to improve efficiency, reduce costs, and accelerate time-to-market for drugs. Meanwhile, MNCs possess funding, data, and extensive experience in drug research and development, but they usually do not develop all tools themselves. In most cases, they prefer to use tools developed by specialized companies.

For AI pharmaceutical companies, collaboration with MNCs represents an opportunity to acquire essential resources, accelerate drug development, and expand business scope. AI pharmaceutical companies often possess deep expertise in a specific technology or disease area. If an AI pharmaceutical company can address the key challenges faced by MNCs with its unique technology and help them understand the technical advantages of its AI drug discovery platform, it will often gain favor from MNCs.

Currently, the application and penetration of AI in new drug research and development have become increasingly profound. The tripartite cooperation model among Sanofi, Formation Bio, and OpenAI—where Sanofi provides proprietary data, Formation contributes engineering resources, and OpenAI offers AI capabilities—represents the most cutting-edge technological integration pathway in the pharmaceutical industry.

References:

Over $10 Billion! MNCs Make Big Bets on AI Drug Development — VCBeat