- Cynata Therapeutics and Fujifilm Corporation entered into a new strategic partnership in a significant step toward commercial manufacturing for Cynata’s Cymerus™ therapeutic mesenchymal stem cell (MSC) products.
- Fujifilm to provide clinical & commercial manufacturing services for the production of Cynata’s Cymerus MSC products.
- Cynata has regained all commercialisation and development rights to its lead product – CYP-001 – for graft-versus-host disease (GvHD) with US$5m fee payable by Fujifilm to Cynata.
Clinical-stage biotechnology company, Cynata Therapeutics Limited (ASX:CYP) has entered into a new strategic partnership with Fujifilm Corporation which includes detailed and agreed core terms for Fujifilm to provide clinical & commercial manufacturing services for, as well as supply of, the Company’s Cymerus™ therapeutic MSC (mesenchymal stem cell) products.
The agreement is a major value catalyst and an important milestone in Cynata’s strategic path to commercialisation for its proprietary MSCs.
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Key details of agreement
Cynata has regained the rights over CYP-001 for GvHD (graft-vs-host-disease), and Fujifilm will pay the Company US$5 million as per the September 2019 licence agreement, which is now terminated.
Over the next 90 days, the two companies will negotiate a manufacturing services agreement (MSA) to produce Cynata’s CymerusTM therapeutic mesenchymal stem cell (MSC) products. These products will be derived from induced pluripotent stem cells (iPSC) for commercial applications and clinical trials.
The partnership agreement sets out the detailed and agreed core terms to be included in the MSA for Fujifilm to carry out technology transfer, process validation and production under stage-by-stage, commercial, arms-length arrangements. The details of the initial stages of the process are currently being finalized with Cynata making an initial in-principle expenditure commitment of about US$2 million.
Image Source: © Helenapavlovich |Megapixl.com
As part of the landmark agreement, Fujifilm has agreed to a voluntary escrow over around 8.1 million shares it holds in the Company. This escrow will be in place for a period of 90 days. It will be extended for up to fifteen months at the time of execution of a manufacturing services agreement.
Cynata to accelerate US regulatory strategy
Cynata will immediately implement a US development strategy for CYP-001, capitalizing on the unmet need and market opportunity for a scalable and effective MSC therapeutic for GvHD in the US market.
The Company already holds Orphan Drug Designation from the FDA (Food and Drug Administration) for CYP-001 for treating GvHD. This potentially provides several commercially important incentives, comprising substantial tax credits, seven years of marketing exclusivity, and a waiver of FDA fees.
The biotech will now work with the FDA to progress the clinical development of CYP-001 in the United States through a Phase 2 clinical trial. An induced pluripotent stem cell (iPSC) master cell bank created by Fujifilm Cellular Dynamics, Inc. will be utilised for this trial. Cynata is the leading company worldwide in developing cell therapy products derived from Nobel-prize winning iPSC technology.
The Phase 2 trial in GvHD will be a considerable late-stage addition to the Company’s active product pipeline, which also includes two ongoing clinical trials: the MEND study in respiratory distress and the Sculptor Phase 3 study in osteoarthritis. A third trial, in diabetic foot ulcers (DFU), is likely to start later this calendar year.
The previously completed Phase 1 clinical trial of CYP-001 in graft-vs-host-disease met all safety and efficacy endpoints and broke ground by being the globe’s first clinical trial of an allogeneic iPSC-derived product. Results from the clinical trial were the subject of a front-page feature article in the prestigious medical journal Nature Medicine.
Cynata’s manufacturing plans
Both entities intend to initially collaborate towards setting up at Fujifilm the current manufacturing process in place at the Company’s existing contract manufacturer, Waisman Biomanufacturing. Meanwhile, products for Cynata’s current clinical trials will continue to be manufactured by Waisman as planned.
It is intended that Fujifilm will have first rights to produce commercial and clinical requirements for Cymerus therapeutic mesenchymal stem cell products. And in recognition of the progress made by Fujifilm, Cynata will pay a share of any upfront license fee received by the Company to Fujifilm if it approves key terms of a GvHD licence agreement with certain third parties within the coming six months.
Cynata shares are trading at AU$0.585 as of 12:44 PM AEST.