Rochester, Minn. — Mayo Clinic is the prime site for an ARPA-H award to develop an implantable device that acts as a living pharmacy, triggering a "cell factory" in the body to treat inflammatory disease. ARPA-H, short for Advanced Research Projects Agency for Health, is an agency within the Department of Health and Human Services. It supports research for potentially transformative biomedical and health breakthroughs.
The award for up to $42.8 million for Engage Assess SecretE (EASE): A Platform for Treating Chronic Inflammation is aimed at creating a revolutionary treatment for inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. Eventually, the hope is to use it for disorders related to an overactive immune system, such as rheumatoid arthritis and psoriasis.
"I am very excited that this project has high societal impact and patient relevance. It represents a prime example of convergence science, where clinicians, biologists and engineers come together to produce a sophisticated solution to improve patient care," says Alexander Revzin, Ph.D., a biomedical engineer and scientist at Mayo Clinic who is the principal investigator for EASE.
The researchers aim to develop a bioelectric device that carries genetically engineered cells to generate monoclonal antibodies to overcome the challenges of inflammatory disease. The high-tech gadget would be implanted in an outpatient procedure.
"It's a futuristic device that encapsulates living cells in a protective membrane to ensure long-term survival. The device will also have the ability to prompt living cells to release biotherapeutic molecules, which, in this case, is monoclonal antibodies," says Suman Bose, Ph.D., a biomedical engineer at Mayo Clinic in Arizona.
Monoclonal antibodies are engineered to target specific proteins involved in the inflammatory process, helping to reduce inflammation and manage symptoms of IBD.
It takes a union of forces
The EASE project brings together a dynamic team of more than 15 investigators from Mayo Clinic in Rochester and Arizona, University of Minnesota, Case Western Reserve University, University of Texas at Dallas, University of California Davis, State University of New York Binghamton and biotech companies EnLiSense and Sersense Inc. The team includes experts in cell encapsulation, biosensing, cell engineering, wound healing/dermatology and manufacturing as well as bioelectronics. Mayo Clinic's Center for Regenerative Biotherapeutics will play a leading role in manufacturing the cells and navigating the high-tech tool through regulatory approval for early-stage clinical trials.
Addressing unmet patient needs
As many as 70,000 Americans are diagnosed with inflammatory bowel disease every year. Flare-ups can cause stomach cramps, diarrhea and rectal bleeding. With no cure, treatment is limited to easing symptoms. Standard care for IBD has been monoclonal antibody treatment over the course of a year. That requires the patient to return to the clinic every two to eight weeks for an infusion. A recent study has shown 1 in 5 patients routinely miss their dosage.
"Skipping an infusion greatly increases the chance of relapse, loss of response and drug resistance," says William Faubion Jr., M.D., the Michael S. and Mary Sue Shannon Family Director, Mayo Clinic Center for Regenerative Biotherapeutics, and a gastroenterologist-researcher for EASE. "Clearly we need better ways of providing anti-inflammatory medicine. Our research will study whether an implantable tool that delivers therapy could improve care."
The high-tech tool will be built in the lab and tested in preclinical studies with a goal of moving rapidly toward first-in-human clinical trials within six years. For more information on ARPA-H awards, visit the ARPA-H website.
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