- Posted Monday October 5, 2020
TGen’s analysis of proteins and metabolites could pave the way for Avery Therapeutics to gain FDA approval of human clinical trials
PHOENIX and TUCSON, Ariz. — Oct. 5, 2020 — Avery Therapeutics Inc. of Tucson has developed an engineered heart tissue, a lab-grown cardiac membrane that can help heal the heart, either following a heart attack or as a result of progressive heart disease.
The heart tissue, called MyCardia™, could revolutionize the treatment of cardiovascular disease, and someday might be applied to other failing organs.
To better understand how MyCardia works — at the infinitesimally small molecular level — Avery has partnered with the Translational Genomics Research Institute (TGen), an affiliate of City of Hope, following an introduction made by the Flinn Foundation.
“Avery turned to TGen to understand which of their membranes are releasing molecules that produce therapeutic benefits,” said Dr. Patrick Pirrotte, Assistant Professor and Director of TGen’s Collaborative Center for Translational Mass Spectrometry. “Our collaboration will help them understand the mechanism of action on the molecular level, and the potential benefits to patients.”
TGen is conducting mass spectrometry analysis of the proteins and metabolites at work in MyCardia’s healing effect on heart-muscle tissue. This supporting data will be used in Avery’s submissions to the Food and Drug Administration (FDA) that could lead to human clinical trials. Up to now, Avery has studied the processes in laboratory and preclinical experiments.
“Avery’s technology is amazing,” Dr. Pirrotte said, noting that the MyCardia membranes actually beat like a heart. “Their idea is that, for a heart that is potentially weak, an inserted cardiac membrane could support regeneration of heart tissue.”
Avery licensed the technology for MyCardia from the University of Arizona, where Avery scientists had worked on developing engineered regenerative tissues to treat cardiovascular disease.
Key to the technology is the advancement in recent years of induced pluripotent stem cells (iPSCs), which can propagate indefinitely and theoretically give rise to every other cell type in the body. They represent a source of cells that could be used to replace those lost to damage or disease. Advancements in iPSC technology led to a Nobel Prize in 2012.
“It’s the concept of being able to take essentially any cell in the body and convert it into an embryonic-like cell, and then being able to make any cell. That’s how we are making our heart-muscle cells,” said Dr. Jordan Lancaster, Avery’s Chief Executive Officer.
Dr. Jen Koevary, Avery’s Chief Operating and Financial Officer, added: “We created the material based on the idea that you can use healthy cells to treat an unhealthy tissue and make it healthy again.”
The Nation’s leading cause of death
More than 30 million Americans have heart disease, resulting in over $39 billion annually in medical treatment costs. Nearly 600,000 patients are newly diagnosed each year, and 650,000 Americans die annually, making it the nation’s leading cause of death.
The condition is most often treated with drugs, but those efforts eventually fail. Heart transplants can help, but suitable donors are scarce, enabling fewer than 3,000 transplants each year. Mechanical hearts that run on battery packs also can help, but they are expensive; patients are often left with limited mobility, poor quality of life and frequent hospital visits.
How MyCardia works
Through minimally invasive laparoscopic or robotic surgery, MyCardia is precisely grafted onto the surface of a damaged heart. It is loaded with a therapeutic cellular payload; a proprietary combination of cardiomyocytes (heart-muscle cells) and fibroblasts (general cells of the body).
Over time, the MyCardia membrane secretes proteins and metabolites, collectively called the secretome, which helps enable the heart to heal itself. The MyCardia eventually disappears. It’s the unique secretome that is being studied at TGen.
“We have lots of data, but we really don’t know what makes it tick,” Dr. Lancaster said.
There are hundreds of factors involved in the MyCardia process, explained Dr. Koevary: “Figuring out exactly how it works is very complex. It’s important for us to know how it’s working so we can, in the future, identify the best patients who would be candidates for treatment.”
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About TGen, an affiliate of City of Hope
Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life-changing results. TGen is affiliated with City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases: www.cityofhope.org. This precision medicine affiliation enables both institutes to complement each other in research and patient care, with City of Hope providing a significant clinical setting to advance scientific discoveries made by TGen. TGen is focused on helping patients with neurological disorders, cancer, diabetes and infectious diseases through cutting-edge translational research (the process of rapidly moving research toward patient benefit). TGen physicians and scientists work to unravel the genetic components of both common and complex rare diseases in adults and children. Working with collaborators in the scientific and medical communities worldwide, TGen makes a substantial contribution to help our patients through efficiency and effectiveness of the translational process. For more information, visit: www.tgen.org. Follow TGen on Facebook, LinkedIn and Twitter @TGen.
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About Avery Therapeutics
Avery Therapeutics, Inc. (“Avery”) is a company dedicated to advancing tissue-engineered therapeutics to treat diseases and injuries to human muscle. Avery's lead product, MyCardia™, is a tissue-engineered heart graft developed to treat heart failure and is currently in the pre-clinical development phase. MyCardia™ is positioned to be the world’s first off-the-shelf allogeneic tissue-engineered product for treating heart failure. For more information visit: AveryThera.com. Follow Avery on LinkedIn and Twitter.
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