I Peace’s GMP-grade iPSCs are key to manufacture Avery Therapeutics’ MyCardiaTM, a proprietary tissue-engineered heart graft developed to treat heart failure.
TUCSON, Ariz. and PALO ALTO, Calif., Dec. 16, 2020 — 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.”
