CRO WuXi AppTec To Conduct Preclinical Safety Studies For Cynata
By Cyndi Root
Cynata Therapeutics announced in a press release that WuXi AppTec, a contract research organization (CRO), will conduct preclinical safety studies of Cynata’s stem cell technology. The agreement calls for WuXi to produce mesenchymal stem cells (MSCs) in support of a clinical trial program for graft versus host disease (GVHD). Dr. Kilian Kelly, Cynata’s VP of Product Development, said, “The team of scientists that will run this project has extensive experience conducting similar studies with other cellular therapy products, which gives us confidence that our program will be conducted to the highest standards.”
Cynata and WuXi Agreement
WuXi will use Cynata’s Cymerus technology for the preclinical studies in GVHD. The studies are to be conducted at WuXi’s facility in St. Paul, MN. Cynata expects to use the data from the studies in a broader clinical program, expected to start in 2015. Cynata also expects the preclinical program to prepare for regulatory filings worldwide.
Cymerus Stem Cell Product
The Cymerus technology, also known as regenerative medicine, shows promise in deriving multiple cell therapeutics, which pharmaceutical companies need to move into stem cell medicine. The platform produces MSCs from a single donor, a method that Cynata says is more efficient than adult stem cell technology. The production process involves using pluripotent stem cells (iPSCs) and mesenchymoangioblast (MCAs) to manufacture MSCs. Cynata’s platform seeks to address the current difficulty of scaling commercial manufacturing. With WuXi’s assistance, Cynata may be able to provide the industry with an “off-the-shelf” source of stem cells.
Cynata Partnerships
The new partnership with WuXi follows Cynata’s February 2014 agreement with Waisman Biomanufacturing for Cymerus development, scale-up, and clinical-grade production. Baillieu Holst Research issued a report on the company including details of the other partnerships that Cynata has been involved with, including Professor Igor Slukvin from the University of Wisconsin-Madison who invented the Cymerus technology. The report analyst considers Wisconsin-Madison a “hotbed of stem cell development,” which could be due in part to the local presence of the Waisman manufacturing facility.
WuXi
Recently, WuXi opened a high-potency active pharmaceutical ingredient (HPAPI) facility in Shanghai, a key move considering high-potency drugs are increasingly used in drug discovery and development. In May, the company received word that the Food and Drug Administration (FDA) approved Ibalizumab (TMB-355), the first approval for a sterile biologic product manufactured in China for U.S. clinical tria