Formation Bio, an AI-native pharma company, and IMIDomics, a precision medicine company focused on immune-mediated inflammatory diseases announced that Formation Bio has licensed worldwide rights to IMIDomics' first-in-class anti-CD226 monoclonal antibody (mAb). The clinical program, which has received IND clearance, will be advanced by Formation Bio in autoimmune indications, initially ulcerative colitis.

The antibody targets CD226 (DNAM-1), a key immune checkpoint involved in regulating several key immune cells thereby affecting both innate and acquired immune responses. By blocking the interaction between CD226 and its ligands CD112 and CD155, the antibody aims to suppress immune overactivation, offering a novel approach for treating patients with autoimmune conditions. These diseases affect millions globally and are often characterized by high rates of treatment failure, loss of response, and limited options after first- and second-line therapies. A mechanistically distinct agent like anti-CD226 has the potential to reach patients underserved by current therapies.

Under the terms of the agreement, IMIDomics will receive an upfront payment, and is eligible for future development and commercial milestones, as well as royalties on potential sales. In addition IMIDomics will receive equity in Riverview Bio, a subsidiary of Formation Bio that has been formed to develop this therapy, which joins Libertas Bio and Highline Bio as part of Formation's growing portfolio of clinical stage asset-centric NewCos.

"This is a high-potential program that fits squarely within Formation Bio's model," said David Steinberg, Chief Business Officer at Formation Bio. "It highlights how our hub-and-spoke approach—combining structured partnerships with fully integrated execution—can unlock value beyond traditional paths. We provide the capital, scale, and trial infrastructure to accelerate development, while partners retain meaningful upside through our shared-equity structure."

The development strategy for the anti-CD226 mAb program was supported by IMIDomics' Immune Mediated Inflammatory Diseases Consortium in Spain, which was established twenty years ago in collaboration with a number of academic institutions. This deep, longitudinal dataset provided potential mechanistic validation, laying a robust and differentiated foundation for clinical advancement.

"We're excited to collaborate with Formation Bio to combine their development capabilities with IMIDomics' deep understanding of complex autoimmune diseases," said Sandy Zweifach, President and Chief Business Officer at IMIDomics. "Advancing our anti-CD226 monoclonal antibody into clinical development is just one example of how our patient insights platform and scientific research—led by our co-founder Dr. Sara Marsal, MD, Ph.D—are translating into meaningful progress. The IND approval of this program, under the direction of our Chief Development Officer Dr. Daniel Perez, MD, marked the first in a pipeline of potential novel therapies targeting these debilitating diseases."

Formation Bio's Platform for Drug Development Acceleration

Formation Bio acquires and advances high-potential therapeutic assets that biopharma companies are unable to prioritize internally. Its model combines deep therapeutic expertise, dedicated operating teams, and a proprietary AI technology platform designed to accelerate asset sourcing, optimize program design, and streamline clinical trial execution—with the ultimate goal of improving development speed, efficiency, and probability of success.

The anti-CD226 mAb adds to Formation Bio's growing pipeline which currently includes programs in immunology, dermatology, and rheumatology and reflects the company's focus on first- and best-in-class programs with clear mechanistic rationale, data-rich foundations, and multi-indication potential.

About Formation Bio

Formation Bio is an AI-native pharma company differentiated by radically more efficient drug development. Formation Bio has built technology and AI platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies and biotechs to develop programs past clinical proof of concept and beyond, leveraging their proprietary tech and AI capabilities, ultimately helping to bring new medicines to patients.

About IMIDomics

IMIDomics is dedicated to discovering and developing first-in-class medicines for immune-mediated inflammatory diseases (IMIDs), particularly for patients without treatment options or unresponsive to current treatments. The company's proprietary Clinical Discovery Engine™ integrates comprehensive longitudinal clinical, epidemiological, and biomolecular data from IMID patients, enabling the identification of disease mechanisms and the development of precision medications which increase the probability of success (PoS). Partnering with the Spanish IMID Clinical Consortium and the Vall d'Hebron Institute of Research (VHIR), IMIDomics is uniquely positioned to deliver the next generation of IMID therapies.