Lycera Corp., a University of Michigan spinoff biotech firm based on campus at Ann Arbor, has begun a Phase 1 clinical trial of the Inflammatory Bowel Disease (IBD Drug) LYC-30937 in healthy volunteers. Lycera is a biopharmaceutical company focused on developing breakthrough immunomodulatory medicines for treating autoimmune diseases and cancer. The drug candidate LYC-30937 is an oral gut-directed ATPase modulator designed to treat the inflamed intestines of people with Crohn’s disease and ulcerative colitis by selectively inducing cell death (apoptosis) in disease-causing immune cells, sparing normal cells. LYC-30937 was discovered and developed by Lycera based on technology licensed from the University of Michigan; the company maintains full worldwide development and commercial rights. The drug’s being a targeted oral formulation makes it an attractive potential alternative to current injected drugs.
The initiation of a clinical trials program for LYC-30937 marks a major milestone passed for Lycera. “This is our first program to enter the clinic, as well as the first ATPase modulator to commence clinical testing,” says Paul Sekhri, President and CEO of Lycera Corp. “Lycera is dedicated to advancing a portfolio of drugs based on breakthrough science that have the potential to offer substantial advances for patient treatment. We are proud of the progress of our lead program, and look forward to further accelerating additional candidates in our pipeline.”
In mid-2016, Lycera expects to initiate clinical studies for its lead immune-oncology product candidate, an agonist of RORgamma, as well as an anti-fibrotic agent, a highly selective ROCK2 (rho-associated kinase II) inhibitor.
“Inflammatory bowel diseases including ulcerative colitis and Crohns disease, are chronic, life-long autoimmune diseases with significant medical needs and the potential for life-threatening complications,” says Dr. H. Jeffrey Wilkins, Chief Medical Officer of Lycera. “In contrast to current injectable treatments, LYC-30937 is an oral agent that acts on a novel target, locally in the gut. Our development plan looks to demonstrate whether the promising preclinical data translates into an effective and well-tolerated novel treatment for patients with ulcerative colitis and inflammatory bowel disease. We are excited to initiate the clinical program and anticipate the completion of the study by year end 2015.”
Based on successful progress of its world-class R&D platform, including expertise in immune metabolism, cell signaling, and immune cell differentiation, Lycera is commencing multiple clinical programs in 2015 and 2016. In addition to the LYC-30937 Phase 1 trial, and oral RORgamma agonists for diverse applications in immune-oncology, Lycera has established two collaborations with Merck to discover, develop and commercialize small molecule therapies for autoimmune disorders. Lycera’s executive and scientific leadership possesses deep experience in drug discovery, development, and commercialization and has close relationships with thought leaders and clinical researchers worldwide. Lead investors in Lycera include InterWest Partners, ARCH Venture Partners, Clarus Ventures, and EDF Ventures.
The ideas behind Lycera got their start more than a decade ago at U-M, in the Chemistry Department laboratory of Gary D. Glick, Ph.D. Working with U-M Medical School researcher Anthony Opipari, M.D., Ph.D. and a team of researchers and students who did the basic research that revealed the promise of a new mechanism and novel small molecules targeting immune cells which cause diseases like lupus, psoriasis, rheumatoid arthritis, and colitis, while sparing healthy cells. That approach became the core technology for Lycera, which licensed patents for this class of drugs from U-M through the university’s Office of Technology Transfer. The Lycera team used this as a starting point, and through subsequent work. discovered LYC-30937.
The Lycera odyssey actually began by happenstance in an Ann Arbor supermarket, where Dr. Glick ran into Dr. Opipari and his wife Valerie Castle-Opipari, M.D., who he knew from a university research committee and who is now chair of the U-M Department of Pediatrics. Drs. Glick and Opipari joined forces in Dr. Glick’s Chemistry lab to study the recently discovered compounds, and became friends as well as research and business partners.
Dr. Glick founded Lycera in 2006, and is currently the company’s Chief Scientific Officer. He was responsible for raising the seed round and Series A financing for the company. Since 1990, Dr. Glick has been a member of the chemistry faculty at the University of Michigan in Ann Arbor, where he presently holds the Werner E. Bachmann Chair in Chemistry. In addition, he is a professor in the department of biological chemistry at the University of Michigan Medical School and a member of the training faculty for the interdepartmental immunology and medicinal chemistry doctoral programs. He is also founder and director of the chemical biology doctoral program at Michigan. Dr. Glick’s research interests focus on drug discovery and development for autoimmune diseases and cancer, chemical-induced apoptosis, nucleic acid structure, folding and recognition, and molecular recognition of nucleic acids by proteins.
Lycera Corp. is based on the U-M campus at Ann Arbor, and has occupied U-M’s North Campus Research Complex — a former pharmaceutical research site that still contained the exact kind of research labs and equipment that Lycera needed — since 2011. The company leases 14,000 square feet at market rates and employs approximately 30 people — up from five when the company launched nine years ago.
Lycera’s work has been fueled by tens of millions of dollars in investment from blue chip venture capital firms, including U-M’s own Michigan Investment in New Technology Startups (MINTS) fund.
Meanwhile, the company has invested some of its money to sponsor research by U-M Medical School research teams — particularly ones that study the autoimmune diseases that are the company’s specialty. That cooperative work could lead to future products or other applications of any of the core technologies that Lycera is now developing.
The company has also offered training opportunities to a broad range of students, and hired recent U-M graduates as well as scientists who once worked for Pfizer when it owned what is now the Lycera-occupied NCRC facility. It also co-sponsors a lecture series.
“I can’t tell you how wonderful it is to be here, as both a faculty member and as a company,” says Dr. Glick, who still holds academic appointments as the Bachmann Collegiate Professor of Chemistry and a joint post in the Medical Schools Department of Biological Chemistry while serving as Lycera’s chief scientific officer. Its the best research site I have ever seen the facilities are amazing, the interactions are amazing, the people are spectacular. I owe a huge debt of gratitude to U-M, and I’m glad that we may be able to do something thats really going to help people.”
Dr. Opipari, who splits his time between the Medical Schools Department of Obstetrics and Gynecology and Lycera, agrees, commenting: “The cross-university effort that led to this technology is a terrific demonstration of what can get accomplished when you bring people from different training backgrounds and different work environments together, he says. U-M is a terrific environment that facilitates and encourages these sorts of non-traditional professional interactions. Otherwise, it would have been very difficult for us to have worked together like we did over the years. That allowed the science to take a course that wasn’t restricted by any sort of administrative boundary.”
Robin Rasor, the managing director of licensing for U-M, says “OTT is very pleased to celebrate Lycera’s first compound making it to the clinic, and we look forward to not only this compound continuing through the regulatory process but also for additional compounds to come from Lycera, adding to U-M’s portfolio of therapeutics in the clinic and on the market.”
Drs. Glick and Opipari note that opportunities for students at Lycera have included medical students, and graduate students and recent alumni of programs from bioinformatics to pharmacology. The company has given them the opportunity to train in a biotech environment on the U-M campus while still deciding on their career paths and for some, this led to employment after graduation that kept them in Michigan.
For Dr. Glick, who is married to a U-M psychiatry professor, the goal of finding better and more targeted treatment for inflammatory bowel disease has a profound personal dimension for him and his wife. Their son has Crohn’s disease, which, along with the related condition ulcerative colitis, are both becoming more common. Science at U-M and elsewhere is showing how the body’s immune system causes the inflammation that initiated a cascade of symptoms that make life miserable for many patients, and can be fatal for some. The Lycera product aims to work upstream from the inflammatory process, and the drug’s formulation is designed to deliver the dose within the gut and not body-wide, to localize effects and reduce side effects.
The new trial is the first step toward determining if the promise observed in U-M and Lycera labs of will be replicated in patients. “That will take years,” says Dr. Glick, and much remains to be seen. But one thing is certain. We would not be where we are without U-M.”
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