Three-way Collaboration with the U.S. Army, Harvard University and Frequency Therapeutics to Focus on Progenitor Cell Regeneration in Muscle

WOBURN, Mass.--(BUSINESS WIRE)-- Frequency Therapeutics, a clinical stage biotechnology company spearheading the movement to harness the body’s innate regenerative potential through their Progenitor Cell Activation (PCA) Regeneration Platform, today announced a Cooperative Research and Development Agreement with Harvard University and the U.S. Army Institute of Surgical Research. The program is focused on small-molecule therapeutics to address several disease indications and conditions involving muscle.

“The U.S. Army’s Institute of Surgical Research is dedicated to addressing the profound unmet clinical needs of our wounded warriors, including investigating innovative approaches to muscle regeneration,” said David Lucchino, President, Co-founder and CEO of Frequency. “While our clinical-stage hearing regeneration program remains a core component of Frequency’s pipeline, this collaboration broadens our PCA Regeneration Platform to treat a variety of muscle injuries by activating muscle satellite cells without removing them from the body.”

The targeted, novel small molecule compounds being investigated, described as progenitor cell activators, are the result of years of compelling research from Lee Rubin, Ph.D., Professor of Stem Cell and Regenerative Biology at Harvard University and Director of Translational Medicine at the Harvard Stem Cell Institute, and Amy Wagers, Ph.D., the Forst Family Professor of Stem Cell and Regenerative Biology at Harvard University. Frequency has brought together these leading researchers from the Harvard Stem Cell Institute with those at the U.S. Army’s Institute of Surgical Research to further advance the science. The work will focus on the potential to activate muscle satellite cells using Frequency’s PCA Regeneration Platform. The target satellite cells are a specific population of progenitor cells in skeletal muscle that play a central role in normal growth of muscle, as well as regeneration following injury or disease.

“The Rubin and Wagers labs are exploring a breadth of diseases for which small molecule activators may have therapeutic opportunities on a wide scale,” said Dr. Rubin. “Through the delivery of simple small molecules, this unique therapeutic approach avoids the complex safety and delivery issues that come with traditional genetic engineering and cell therapies, while restoring healthy tissue within the body. Both Dr. Wagers and I are looking forward to seeing what new compounds can be developed to address multiple disease indications.”

“I see a huge unmet need every day in the form of our wounded war fighters and the current issues surrounding muscle repair for existing wounds. The breakthrough regenerative technology being developed in this partnership has great potential to have profound impact for our soldiers,” said Josh Wenke, Ph.D., Manager of Extremity Trauma & Regenerative Medicine at the U.S. Army Institute of Surgical Research.

“Dr. Rubin, in collaboration with Dr. Wagers, was able to isolate muscle satellite cells, even though they are present in small numbers, and identify drugs that can increase their proliferation in vitro and in vivo, leading to accelerated repair of injured muscle,” said Chris Loose, Ph.D., Co-founder and Chief Scientific Officer of Frequency. “Frequency’s PCA Regeneration Platform has the potential to address more than just rare or life-threatening diseases, including common conditions with large unmet needs such as hearing loss, alopecia and wound care, and we’re excited to see what will come from these research collaborations.”

The joint collaboration in muscle indications comes on the heels of the recent success of Frequency’s first-in-human safety study for hearing restoration in Australia. Frequency’s lead program for hearing regeneration is advancing to Phase 2 studies, and the company plans to launch these clinical trials in the U.S. in 2018.

The terms of the agreements were not disclosed.

ABOUT PCA REGENERATION
Frequency’s precise and controlled approach transiently causes Lgr5+ progenitor cells to divide and differentiate, much like what is seen in naturally regenerating tissues such as the skin and intestine. Frequency activates ‘stemness’ through mimicking signals provided by neighboring cells (the stem cell niche) with small molecules, and this proprietary approach is known as the Progenitor Cell Activation (PCA) Regeneration platform. Frequency believes that PCA Regeneration has the potential to yield a whole new category of disease-modifying therapeutics for a wide range of degenerative conditions. To fuel its drug discovery programs, Frequency is leveraging a PCA screening platform using primary human cells, including cochlear progenitor cells and adult progenitor cells from the GI tract. Potential applications include hearing loss, skin disorders and gastrointestinal diseases.

ABOUT HARVARD STEM CELL INSTITUTE
The Harvard Stem Cell Institute (HSCI) was formed in 2004 to advance the understanding of human development and disease, support the discovery of stem cell-based therapies and cures for diseases, create collaborations across traditional institutional and disciplinary boundaries, and teach and train the next generation of leading stem cell scientists. To accomplish this, the HSCI brings together more than 1,000 scientists in the schools and affiliated hospitals of Harvard University, funds novel research, and implements new collaborative academic and industrial models.

ABOUT HARVARD DEPARTMENT OF STEM CELL AND REGENERATIVE BIOLOGY
The Harvard Department of Stem Cell and Regenerative Biology (HSCRB) was founded in 2007 as the first cross-school department, spanning the Faculty of Arts and Sciences and the Harvard Medical School. HSCRB is dedicated to undergraduate, graduate, and medical education, as well as research on human development, tissue maintenance and repair, and disease. With medical and industry collaborators, HSCRB faculty bridge fundamental research, medical science, and life science entrepreneurship to advance scientific discovery and improve human health.

ABOUT U.S. ARMY INSTITUTE OF SURGICAL RESEARCH
The Army Institute of Surgical Research began as the Surgical Research Unit at Halloran General Hospital, Staten Island, New York in 1943. It was later moved to Brooke Army Medical Center and subsequently renamed the Army Institute of Surgical Research. The current USAISR is a part of the US Army Medical Research and Materiel Command, and is co-located with Brook Army Medical Center at Joint Base San Antonio – Fort Sam Houston, Texas. The USAISR staff includes over 850 military and civilian staff members and contract employees.

ABOUT FREQUENCY THERAPEUTICS
Frequency Therapeutics develops small molecule drugs to stimulate cells in the body to reverse biological deficits and restore healthy tissue. Through the transitory activation of these cells, Frequency enables disease modification without the complexity of genetic engineering. Our breakthrough therapy uses a proprietary combination of small-molecule drugs that induce dormant progenitor cells to multiply and create new cells. Our platform technology is founded on discoveries in progenitor cell biology by Bob Langer, Sc.D. at MIT and Jeff Karp, Ph.D., at Harvard, with contributions from Xiaolei Yin, Ph.D. and other members of the Karp Lab at Harvard and Brigham & Women’s Hospital. www.frequencytx.com.

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