I Peace’s GMP-grade iPSCs are key to manufacture Avery Therapeutics’ MyCardia™, a proprietary tissue-engineered heart graft developed to treat heart failure
TUCSON, Ariz. and PALO ALTO, Calif., Dec. 17, 2020 /PRNewswire/ — Avery Therapeutics, a Tucson-based company dedicated to advancing tissue-engineered therapeutics to treat diseases and injuries to human muscle, and I Peace, Inc., a Palo Alto-based biotech startup developing, mass-manufacturing, and commercializing Nobel Prize-wining technology of induced pluripotent stem cells (iPSCs), announced a service agreement to advance cell therapy for heart failure. Under the agreement, I Peace will generate and supply GMP-grade induced pluripotent stem cells (iPSCs) and related services to Avery Therapeutics. Avery Therapeutics will use the iPSCs to derive cells used in the manufacturing of MyCardiaTM.
Avery Therapeutics is projected to be one of the first companies in the US to seek approval for a clinical trial using iPSC-derived technology for heart failure. The goal of this collaboration is to develop a new off-the-shelf treatment to improve the quality of life of patients suffering from heart failure, a debilitating disease that affects tens of millions of people worldwide.
The iPSCs are manufactured at I Peace’s state-of-the-art GMP facility in Kyoto, Japan, under comprehensive validation programs of the facility, equipment, and processes including donor recruiting, screening, blood draw, iPSC generation, storage, and distribution. I Peace has obtained a US-based independent institutional review board (IRB) approval for its process of donor sourcing for commercial-use iPSCs. The facility is designed to be PMDA and USFDA compliant.
As Avery Therapeutics expects to expand the application of its regenerative medicine technology to various types of heart diseases and beyond, iPSCs are the key enabling technology for quality and future scalability. This agreement provides a solid foundation to improve the welfare of those suffering from diseases through advancement of tissue-engineered therapeutics.
"We are thrilled to announce this collaboration with I Peace. It is a big step forward in the development of novel cell-based therapeutics for unmet medical needs. Through this collaboration, I Peace brings deep iPSC development and manufacturing expertise to enable Avery’s proprietary MyCardia cell delivery platform technology. Together we hope to positively impact millions of patients worldwide in the near future," Said Jordan Lancaster, PhD, Avery Therapeutics’ CEO.
This agreement reflects an innovative collaboration involving multiple locations internationally and marks a significant milestone for both I Peace, Inc. and Avery Therapeutics to pursue one of the first US clinical trials using iPSC technology in the area of heart diseases. Koji Tanabe, PhD, founder and CEO of I Peace stated: "By combining I Peace’s proprietary clinical grade iPSC technology and Avery’s tissue engineering technology, we can bring the regenerative medicine dream closer to reality. We are very excited by Avery’s technology and look forward to continue working together."
About I Peace, Inc
I Peace, Inc. is a global supplier of clinical and research grade iPSCs. It was founded in 2015 in Palo Alto, California, USA by Dr. Tanabe, who earned his doctorate at Kyoto University under Nobel laureate Dr. Shinya Yamanaka. I Peace’s mission is to alleviate the suffering of diseased patients and help healthy people maintain a high quality of life by making cell therapy accessible to all. I Peace’s state-of-the-art GMP facility and proprietary manufacturing platform enables the fully-automated mass production of discrete iPSCs from multiple donors in a single room. Increasing the available number of clinical-grade iPSC lines allows I Peace customers to take differentiation propensity into account to select the most appropriate iPSC line for their clinical research at significantly reduced cost. I Peace aims to create iPSCs for every individual that become their stem cell for life.
Founder, CEO: Koji Tanabe
Head Quarter: Palo Alto, California
Japan subsidiary: I Peace, Ltd. (Kyoto, Japan)
Cell Manufacturing Facility: Kyoto, Japan
About Avery Therapeutics
Avery Therapeutics is a company developing advanced therapies for patients suffering from cardiovascular diseases. Avery’s lead candidate is an allogeneic tissue engineered cardiac graft, MyCardia™ in development for treatment of chronic heart failure. Using Avery’s proprietary manufacturing process MyCardia can be manufactured at scale, cryopreserved, and shipped ready to use. Avery is leveraging its proprietary tissue platform to pursue other cardiovascular indications. For more information visit: AveryThera.com. Follow Avery Therapeutics on LinkedIn and Twitter.
Headquarter: Tucson, AZ