Narrative: Lycera Corp.

Transforming the Treatment of Autoimmune Diseases

There are more than 80 different types of autoimmune disorders, and approximately one in five people in the US suffer from autoimmune diseases. Lycera Corp. works on the discovery and development of selective, small-molecule immune-modulators for the treatment of patients with autoimmune diseases such as rheumatoid arthritis, psoriasis and inflammatory bowel disease.

Focused on the emerging areas of cellular bioenergetics and immune-metabolism, the company is developing drug candidates that selectively target and silence pathologically activated cells, and which have the potential for first-in-class oral efficacy without the adverse effects of current standard-of-care antiproliferative and immunosuppressive agents.

Lycera’s leadership team and advisors represent the core thought leaders in immunology, inflammation, medicinal chemistry and relevant biology and are responsible for key advances and discoveries in these fields. The ability to build academic collaborations and discuss cutting edge science within the speaker series at NCRC has been an outstanding opportunity for Lycera, and they have recruited a team with exceptional expertise in chemistry, biology and preclinical development. Dr. Anthony Opipari Jr., MD, for example, contributes to Lycera in the research team as a Senior Director of Biology. In this role, Dr. Opipari investigates new mechanisms of action to identify new targets for drug discovery and development. Dr. Opipari also serves as Associate Professor, Obstetrics & Gynecology, University of Michigan Medical School.

2013 saw Lycera add substantial leadership capabilities with the hires of Laura Carter, PhD Vice President, Biology, and Bruce Goldsmith, PhD, Chief Business Officer. Dr. Goldsmith most recently served as senior vice president corporate development at Allos Therapeutics, where he led the successful sale of the company and, previously, executed a global collaboration for the co-development and commercialization of the company’s lead oncology asset outside of North America. Dr. Carter was previously scientific director in the respiratory, inflammation and autoimmunity group at MedImmune, where she was responsible for overseeing research and development of treatments for autoimmune diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis and multiple sclerosis.

Lycera was started in 2006 as a spin-out from the University of Michigan by founder and Chief Scientific Officer Dr. Gary D. Glick, Werner E. Bachmann Chair in Chemistry, based on his original work on the science of immune metabolism. The company’s immune metabolism programs have identified novel small molecules that function as non-immunosuppressive immune modulators.

The company’s lead ATPase Modulator program exploits the specific bioenergetic profile of chronically activated immune cells that underlies autoimmune disease. ATPase Modulators selectively cause cell death, or apoptosis, in disease-causing immune cells. Since healthy immune cells are largely unaffected, this new class of immune modulators is expected to provide efficacy against autoimmune disease without immunosuppression.

Work at Lycera has shown that ATPase Modulators have outstanding efficacy in multiple preclinical autoimmune models. In translational studies, the modulators mediate cell death of pathogenic lymphocytes in tissue samples from patients. The lead compound offers potentially improved safety over existing systemic therapies by focusing immune suppression only where needed and only on disease causing cells.

Lycera has demonstrated that ATPase Modulators are highly effective in preclinical models of rheumatoid arthritis, psoriasis, lupus and acute graft-versus-host disease. There is also a strong scientific rationale supporting the potential of ATPase Modulators in selected oncology indications. ATPase Modulators may, therefore, represent a significant opportunity to create a portfolio of first-in-class drugs to treat a broad spectrum of autoimmune and other diseases. Lycera is rapidly advancing its lead ATPase Modulator to human clinical studies.

In February 2013 Lycera announced a collaboration agreement with Merck, known as MSD outside the United States and Canada, to discover, develop and commercialize small-molecule therapies directed to selected novel targets being investigated for the treatment of a broad range of immune-mediated disorders.

Lycera has been developing several approaches to control the differentiation and function of cells that produce the IL-17 family of cytokines, including T-helper 17 (Th17) cells. Th17 cells are a unique subset of CD4+ T cells that have been implicated in autoimmune disease. One therapeutic target in this program, RORγt, is the master transcription factor that orchestrates the differentiation of Th17 cells, inducing transcription of the genes encoding IL-17 family members. Lycera identified novel, potent and specific antagonists of RORγt that reduce IL-17 production in primary cells and in vivo.

“There are substantial unmet medical needs and opportunities in autoimmune disorders, and new targets representing attractive opportunities that we are very pleased to pursue through our new collaboration with Lycera,” said Rupert Vessey, D.Phil., FRCP, senior vice president, global scientific strategy, Merck Research Laboratories. “Lycera’s innovative capabilities and productivity, exemplified by the RORγt program on which we currently collaborate, make them ideal partners for Merck in this area of drug discovery.”

Lycera CEO Dr. Kathleen Metters, PhD, said “The dynamic environment at NCRC and the opportunity to collaborate more broadly across the health sciences sector within Michigan make this a truly outstanding research setting. This is a great home for Lycera and we will continue to look for ways to work with other groups in the public and private sector.”

Under the terms of the agreement with Merck, Lycera will receive an upfront payment and research funding, and is eligible to receive in excess of $300 million in research, development, regulatory and commercial milestone payments. Merck is responsible for clinical development and will have worldwide marketing and commercialization rights to any products that may be developed as a result of the collaboration. Lycera is entitled to receive royalty payments, as well as development and sales milestones, on global sales from any such products.

“We are absolutely delighted to expand our relationship with Merck, a collaboration that builds on the culture of scientific excellence fostered by both companies,” said Dr. Metters. “Lycera’s proven track record in accelerating early stage programs to development candidate status holds the potential to fuel Merck’s early stage pipeline.”

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