“During our residence at the NCRC, Lycera has advanced significantly, building a promising pipeline of therapeutic candidates”Paul Sekhri, President and CEO, Lycera
Lycera is a biopharmaceutical company with a mission to develop new classes of oral immune modulators that can selectively suppress or activate the immune system, for the treatment of autoimmune diseases and cancer.
As Paul Sekhri, President and CEO of Lycera, notes: “Lycera has benefitted greatly from our presence in the NCRC community and our close collaborations with leading researchers at the University of Michigan. Central to these efforts have been NCRC’s acclaimed resources and facilities to support translational research in the life sciences. During our residence at the NCRC, Lycera has advanced significantly, building a promising pipeline of therapeutic candidates to address unmet needs in immunology and immuno-oncology.”
Lycera has built a world-class R&D engine by leveraging its expertise in immunology, metabolism, and chemistry to generate a portfolio of highly promising drug targets based on compelling science and prevailing medical need. Supported by a culture of scientific excellence, innovation, and collaborative working relationships with premier researchers worldwide, Lycera has built a portfolio of selective immune modulators that promise not simply incremental gains, but substantial advances in treatment, offering novel mechanisms of action to deliver improved efficacy and safety profiles.
The company’s lead clinical candidate, LYC-30937-Enteric Coated, was developed by Lycera based on ATPase modulators developed by Dr. Gary Glick, Ph.D., Werner E. Bachman Professor of Chemistry at the University of Michigan, and in-licensed from the University of Michigan. LYC-30937-EC was developed as an orally administered gut-directed therapy that combines localized activity with selective action against disease-causing immune cells.
Dr. Peter D. R. Higgins, M.D., Ph.D., Director of the Inflammatory Bowel Disease Program at the University of Michigan Health System presented positive preclinical findings for the LYC-30937-EC program at the European Crohns and Colitis Organisation Congress in March 2016. LYC-30937-EC has now completed Phase 1 clinical studies in healthy volunteers and expects to initiate a Phase 2 clinical study in patients with ulcerative colitis in mid-2016.
Lycera’s most advanced program in cancer immunotherapy focuses on oral, selective RORγ (“RORγ”) agonists. The retinoic acid-related orphan receptor-gamma t (RORγt) is a nuclear receptor transcription factor that acts as a immune cell master control switch driving the generation and function of Th17 (helper) and Tc17 (cytotoxic) T cells. The company’s RORγ agonists combine multiple anti-tumor mechanisms into a single therapeutic by modulating gene expression to reprogram immune cells for improved function, as well as decrease immunosuppressive mechanisms. Based on the company’s ground breaking research, Lycera plans to initiate clinical studies in 2016 with an oral, selective RORγ agonist compound.
Lycera and Celgene agreement
In June 2015 Lycera and Celgene announced a global strategic collaboration to advance Lycera’s innovative pipeline, including Lycera’s first-in-class RORy agonists for cancer immunotherapy, and clinical-stage candidate, LYC-30937-EC, being studied for inflammatory bowel disease (IBD). Under the terms of the agreement:
- Lycera received an $82.5 million upfront cash payment.
- The upfront payment included an exclusive option for Celgene to license Lycera’s portfolio of ex vivo RORy agonist compounds., which was exercised for an additional $17.5M payment.
- As part of the strategic agreement, Celgene obtains the exclusive right to acquire Lycera upon conclusion of the option period or achievement by Lycera of pre-specified clinical milestones. During the option period, Lycera will retain full control of its research and development programs.
- Following the exercise of the option to acquire Lycera, shareholders will be also eligible to receive future success-based milestones.
“We are very excited to partner with Lycera, a company that has created two programs based on great, potentially breakthrough science,” said George Golumbeski, Senior VP of Business Development & Licensing at Celgene. “The collaboration structure utilized here allows us to work very closely with Lycera to expand and progress their programs, and the structure aligns all involved in the work toward a future M&A event. I very much look forward to seeing these exciting programs mature.”
“The collaboration structure utilized here allows us to work very closely with Lycera to expand and progress their programs”George Golumbeski, Senior VP of Business Development & Licensing, Celgene