The multi-year agreement includes funding by Lilly of R&D at Topas with potential future milestone payments.

Eli Lilly recently demonstrated its commitment to the development of treatments for inflammation and/or autoimmune diseases with the announcement of a multi-year research and option agreement signed with Topas Therapeutics GmbH. The amount of the agreement was not disclosed, but Lilly will provide funding for research and development at Topaz and make milestone payments for future successes. Lilly has the option to in-license and further develop all of the candidates produced under the agreement. Topaz will conduct the preclinical proof-of-principle studies with Lilly. 

Lilly has committed to increasing investment in various R&D areas, including immunology, which is one of five areas in which Lilly plans to launch 20 new products by 2023 (the others include cancer, diabetes, neurodegeneration, and pain). 

The company’s leading candidate is ixekizumab (LY2439821), a biologic drug for the treatment of spondyloarthritis that acts by neutralizing interleukin-17A (IL-17A). This compound is in Phase III trials. The company is also assessing its options with respect to baricitinib, a once-daily oral rheumatoid arthritis drug that it is developing with Incyte. FDA issued a Complete Response Letter rejecting the drug. Lilly has indicated that that resubmission of a New Drug Application (NDA) for baricitinib will not take place this year. The companies are considering conducting an additional clinical study requested by FDA. Baricitinib is also in separate Phase II studies for the treatment of atopic dermatitis and systemic lupus erythematosus.

“Lilly is committed to be an innovation leader in immunology,” said 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."

Topas was spun out of Evotec in 2016 in order to focus on the development of nanoparticle-based therapeutics for immunological disorders. It received initial funding from Evotec, Epidarex Capital, EMBL Ventures, and Gimv. 

The Topas technology is an antigen-specific tolerance induction platform designed to induce antigen-specific immune tolerance by harnessing the liver's natural immunology capabilities, according to the company. Peptide-loaded nanoparticles are selectively targeted toward liver sinusoidal endothelial cells (LSECs), where tolerance against blood borne 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 against external antigens,” said Timm Jessen, Ph.D., CEO of Topas Therapeutics. “Additionally, the interest from such an important pharmaceutical company in our technology, we believe, supports the strong commercial potential of our work.”

Timm Jessen, Ph.D., CEO of Topas Therapeutics

Image courtesy of Topas Therapeutics.