Lycera

Lycera Corp. is a privately held biopharmaceutical company developing novel small molecule immunomodulatory medicines for autoimmune diseases and cancer. Founded in 2006 as a University of Michigan spinout in Ann Arbor, Michigan, the company was based on research by Gary D. Glick, the Werner E. Bachman Professor of Chemistry at U-M, on immune system-modulating drug candidates for diseases including rheumatoid arthritis, lupus erythematosus, psoriasis, inflammatory bowel disease and graft-versus-host disease. Its research spans three distinct but complementary areas: immune metabolism, cell signaling, and immune cell differentiation, with the aim of recalibrating immune responses through selective immune modulators.

The company's lead assets included cintirorgon (LYC-55716), an oral RORγ agonist that completed a single-agent Phase 2 study across six tumor types (n=86) in 2019 and a Phase 1b combination study with pembrolizumab initiated in 2018 in metastatic non-small cell lung cancer patients who had relapsed on pembrolizumab; LYC-30937, a gut-directed oral ATPase modulator evaluated in a Phase 2 double-blind placebo-controlled study in ulcerative colitis and a Phase 2 study in psoriasis; LYC-30824, a LYC-30937 backup positioned to enter GLP toxicology studies; LYC-56056, a RORγ antagonist for autoimmune disease; a portfolio of ex vivo RORγ agonists applicable to adoptive cell therapy including CAR-T; preclinical selective inhibitors of the kinase ROCK II; a contingent revenue stream from an out-licensed GCN2 program; and a library of approximately 8,000 small molecule compounds targeting kinases, NLRP3, CD73, histone deacetylases, mitochondrial ATPase, nuclear receptor family members and the STING pathway.

By August 2020 Lycera was described as located in Plymouth Meeting, Pennsylvania, and its board had approved a search for a strategic partner, with Gerbsman Partners retained to run a date-certain sale of substantially all company assets.

Founding story

Lycera Corp. was founded in Ann Arbor in 2006 as a spinout of the University of Michigan by Gary D. Glick, the Werner E. Bachman Professor of Chemistry, based on his U-M research into immune system-modulating drug candidates targeting a novel therapeutic pathway that showed efficacy in animal models without side effects associated with existing treatments.

Business model

Lycera operated as a research and development-stage biopharmaceutical company, discovering and advancing proprietary small molecule drug candidates and monetizing them through pharmaceutical partnerships, licensing and option-to-acquire arrangements rather than through commercial product sales.

Revenue derived from partnership economics rather than product sales: an $82.5 million upfront payment from Celgene under the 2015 collaboration, potential near-term payments of an additional $22.5 million tied to ex vivo licensing option rights, eligibility for future success-based milestones, and a contingent revenue stream of clinical and regulatory milestones plus royalties on net sales from an out-licensed GCN2 program.

Traction

In 2019 Lycera completed a Phase 2 single-agent study of cintirorgon (LYC-55716) in six tumor types (n=86). A Phase 1b combination study with pembrolizumab initiated in 2018 reported that 64% of patients showed reduction of tumor burden, with one confirmed partial response in a patient remaining on drug after two years. LYC-30937 was evaluated in Phase 2 studies in ulcerative colitis and psoriasis. Cumulative investment including the Celgene partnership totaled $180 million.

Latest developments

In August 2020, Gerbsman Partners announced it had been retained by Lycera Corp. to solicit interest in acquiring all or substantially all of the company's assets, including clinical and preclinical drug candidates and its patent estate, after the board approved a search for a strategic partner to continue development.