MELBOURNE, AUSTRALIA: Cynata Therapeutics Limited has executed a Manufacturing Services Agreement (MSA) with FUJIFILM Cellular Dynamics, for the manufacture and supply of Cynata’s Cymerus therapeutic mesenchymal stem cell (MSC) products derived from induced pluripotent stem cells (iPSCs) for clinical trials and commercial applications.
This new agreement was foreshadowed in the Strategic Partnership Agreement between FUJIFILM Corporation (FCDI’s parent company) and Cynata, as announced on 30 September 2021.
Further details regarding the terms of the MSA are provided in the 30 September 2021 announcement.
Cynata and FCDI will now work toward establishing the Cymerus manufacturing process at FCDI.
The MSA anticipates FCDI undertaking technology transfer, process validation and manufacturing under stage-by-stage, commercial, arms-length arrangements, as previously announced. Cynata’s existing contract manufacturer, Waisman Biomanufacturing, will continue to manufacture product for Cynata’s current clinical trials, which are proceeding as planned.
As also previously announced, the execution of the MSA triggers a 12-month extension of the current voluntary escrow over the approximately 8.1 million shares FUJIFILM Corporation holds in Cynata.
Dr Kilian Kelly, Cynata’s Chief Operating Officer, said: “The execution of this new manufacturing services agreement with FCDI leverages both our strong strategic relationship with FUJIFILM and the extensive experience in cell therapy manufacture at FCDI, where the original iPSC line utilised in our Cymerus process was developed.
Ultimately, we foresee FCDI manufacturing product for our growing pipeline of clinical trials in high value indications and potentially for commercial use.
This provides a turn-key manufacturing solution that our future corporate partners may avail themselves of.
Importantly, FUJIFILM has also confirmed a strong commitment to our relationship by agreeing to extending the voluntary escrow over their shares in Cynata.”
Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus, a proprietary therapeutic stem cell platform technology.