Wanting In on US Market, Cynata Taps Fujifilm to Advance Stem Cell Products

Melbourne, Australia-based Cynata Therapeutics has formed a new partnership with Japan’s Fujifilm Corporation to develop and commercialize its proprietary Cymerus stem cell technology. Under agreed terms for the deal, Fujifilm will manufacture and supply Cynata’s mesenchymal stem cell (MSC) products for clinical trials and sales.

Details of the manufacturing services agreement will be ironed out between the two companies over a 90-day period.

Cynata currently sources its products from its contract manufacturer, Waisman Biomanufacturing. The company intends to keep Waisman as its supplier while further establishing the current manufacturing process at Fujifilm.

“The new strategic agreement builds on the partnership with Cynata to maximize the strengths and resources of both companies and further promote industrial application of iPSC cell-derived regenerative medicine,” said Yutaka Yamaguchi, General Manager of Fujifilm Life Sciences Division.

Cynata Regains Rights to CYP-001 for US Ambitions

In a notable development, Fujifilm will return Cynata the rights to its lead stem cell product CYP-001 for graft-versus-host disease (GvHD). Fujifilm will also pay $5m to Cynata as per a 2019 licensing agreement. 

GvHD is a complication that may arise following bone marrow transplant or similar procedures, where stem cells from the donor (graft) attack the tissues of the recipient (host). Acute GvHD may develop in up to 50% of patients receiving the transplantation. CYP-001 uses induced pluripotent stem cell-derived mesenchymal stem cells (MSC), which are known to suppress this immune assault.

Cynata had previously secured Orphan Drug Designation for CYP-001 from the FDA. The status provides significant government incentives, including seven-year market exclusivity, tax reduction, and a waiver of FDA fees.

Fujifilm bought the exclusive license to CYP-001 in September 2019 following promising results from a Phase 1 trial in patients with steroid-resistant acute GvHD.

CYP-001 is also being investigated in Cynata’s SCUlpTOR Phase 3 trial to treat patients with osteoarthritis and in the MEND trial in respiratory distress caused by COVID-19 and other causes. Having regained rights to CYP-001, Cynata is mulling a push into the US market. The company plans to begin Phase 2 trials for CYP-001 in the US, using Fujifilm’s iPSC master cell bank. There, they will face an uphill battle to get their therapy approved by the FDA. The drug regulator has yet to approve a stem cell therapy for acute GvHD.

Mesoblast’s Ryoncil (remestemcel-L), an MSC treatment for pediatric acute GvHD, was hit with an FDA Complete Response Letter (CRL) in 2020. The FDA at the time recommended Mesoblast to conduct at least one more randomized clinical study to provide further evidence for their therapy.

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Joy Lin

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