Formation Bio, an AI-native pharmaceutical company, has secured worldwide licensing rights to IMIDomics' first-in-class anti-CD226 monoclonal antibody, marking a significant expansion of the company's immunology pipeline with a Phase 1-ready drug candidate. The clinical program has received IND clearance and will initially advance in ulcerative colitis, with Formation Bio planning to explore additional autoimmune indications.
Novel Immune Checkpoint Target
The monoclonal antibody targets CD226 (DNAM-1), a key immune checkpoint involved in regulating several immune cell types, 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 mechanistically distinct approach for treating autoimmune conditions.
This novel mechanism addresses a significant unmet medical need, as autoimmune diseases affect millions globally and are often characterized by high rates of treatment failure, loss of response, and limited therapeutic options after first- and second-line therapies fail. A mechanistically distinct agent like anti-CD226 has the potential to reach patients underserved by current therapies.
Strategic Partnership Structure
Under the licensing agreement, IMIDomics will receive an upfront payment and is eligible for future development and commercial milestones, as well as royalties on potential sales. Additionally, IMIDomics will receive equity in Riverview Bio, a newly formed subsidiary of Formation Bio created specifically to develop this therapy. Riverview Bio joins Libertas Bio and Highline Bio as part of Formation's growing portfolio of clinical-stage asset-centric companies.
"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."
Robust Scientific Foundation
The development strategy for the anti-CD226 monoclonal antibody program is supported by IMIDomics' Immune Mediated Inflammatory Diseases Consortium in Spain, which was established twenty years ago in collaboration with multiple 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 IMIDomics' Chief Development Officer Dr. Daniel Perez, MD, represents the first in a pipeline of potential novel therapies targeting debilitating autoimmune diseases.
Formation Bio's Development Platform
Formation Bio's business model focuses on acquiring and advancing high-potential therapeutic assets that biopharma companies are unable to prioritize internally. The company 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 monoclonal antibody adds to Formation Bio's growing pipeline, which currently includes programs in immunology, dermatology, and rheumatology. This acquisition reflects the company's focus on first- and best-in-class programs with clear mechanistic rationale, data-rich foundations, and multi-indication potential.
IMIDomics brings specialized expertise in immune-mediated inflammatory diseases through its proprietary Clinical Discovery Engine™, which integrates comprehensive longitudinal clinical, epidemiological, and biomolecular data from IMID patients. This platform enables the identification of disease mechanisms and the development of precision medications designed to increase the probability of success in clinical development.
