Eli Lilly will use Topas Therapeutics’ antigen-specific tolerance induction platform to develop new treatments, with an initial focus on external antigens believed to induce inflammation and/or autoimmune disease, Topas said today.

The companies have signed a multiyear research and option agreement whose value was not disclosed.

Topas did say, however, that it will receive from Lilly R&D funding and payments tied to unspecified “future success” of compounds to be in-licensed by Lilly. The pharma giant has been granted an option for all candidates produced under the collaboration for in-licensing and further development, while Topas has agreed to conduct preclinical proof-of-principle studies with Lilly to generate the drug candidates.

Topas says its platform is designed to induce antigen-specific immune tolerance by harnessing the liver's natural immunology capabilities. Through the platform, peptide-loaded nanoparticles are selectively targeted toward liver sinusoidal endothelial cells (LSECs), where tolerance against bloodborne antigens is induced by the generation of peptide-specific regulatory T cells.

“We expect this work to support the value of our approach in inducing tolerance also against external antigens,” Timm Jessen, Ph.D., CEO of Topas Therapeutics, said in a statement. “Additionally, the interest from such an important pharmaceutical company in our technology, we believe, supports the strong commercial potential of our work.”

Based in Hamburg, Germany, Topas was spun out of Evotec last year to develop nanoparticle-based therapeutics for immunological disorders. Evotec joined Epidarex Capital, EMBL Ventures, and Gimv in raising €14 million ($16.5 million) in Series A financing for the new company, with proceeds intended to expand and accelerate the platform and advance treatment candidates for multiple autoimmune and inflammatory indications.

Commitment to Immunology

Lilly’s collaboration with Topas also reflects the pharma’s stated commitment to increasing R&D spending and hiring in strategic areas that include immunology—a commitment Lilly cited even as it eliminated 200 R&D jobs worldwide earlier this year.

Lilly’s immunology pipeline is anchored by the Phase III candidate ixekizumab (LY2439821), a biologic designed to treat axial spondyloarthritis by neutralizing interleukin-17A (IL-17A).

But Lilly’s immunology pipeline also suffered a setback earlier this year when the FDA issued a Complete Response Letter rejecting an application for the once-daily oral rheumatoid arthritis drug baricitinib, which the pharma giant is developing with Incyte—just weeks after the oral Janus kinase 1 and 2 (JAK1/2) inhibitor was approved in Europe under the brand name Olumiant®.

Lilly acknowledged last month that resubmission of a New Drug Application (NDA) for baricitinib will be delayed beyond this year as the company and Incyte assess options that include an additional clinical study sought by the FDA. Baricitinib remains in Phase II development for atopic dermatitis and systemic lupus erythematosus.

Immunology is one of five areas where Lilly has said it plans to launch 20 new products by 2023; the other four areas are cancer, diabetes, neurodegeneration, and pain.

“Lilly is committed to be an innovation leader in immunology,” added Thomas F. Bumol, Ph.D., svp of biotechnology and immunology research at Lilly. “Topas has a very novel approach to immune tolerance induction, which we would like to see successfully applied to certain disease-relevant antigens. We look forward to working together with Topas on their unique platform.”

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