Cynata enters into new manufacturing partnership with Fujifilm

Biotech News: Australian stem cell and regenerative medicine company, Cynata Therapeutics, has entered into a new strategic partnership agreement with Japan-based Fujifilm.

Cynata has regained rights to its Cymerus mesenchymal stem cell (MSC) product, CYP-001, for graft-vs.-host disease (GVHD) from former licensee Fujifilm with the two companies negotiating a new partnership under which Fujifilm will manufacture the product.

Cynata will immediately implement a US development strategy for CYP-001 to capitalise on the unmet need and market opportunity for an effective and scalable MSC therapeutic for GvHD in the US market, for which it has already secured Orphan Drug Designation.

Dr Ross Macdonald, Cynata’s Chief Executive Officer, said “The execution of this new strategic partnership agreement with Fujifilm builds on a long and productive relationship between the two companies. Fujifilm Cellular Dynamics (a Fujifilm subsidiary) developed the original iPSC line used in Cynata’s Cymerus manufacturing process and we look forward to the extensive experience in cell therapy manufacture among the Fujifilm group being of significant long-term benefit to Cynata as we advance the development of our unique MSC therapeutic products.

“With Cynata having secured Orphan Drug Designation and regaining development and commercialisation rights to the GvHD indication we are excited to accelerate development in the important US market. This is especially so with our Cymerus technology addressing many of the complexities and challenges of manufacturing MSCs at commercial scale and with the FDA having shown its willingness to consider MSCs as a new treatment modality where the product has a scalable manufacturing process to maintain product consistency. Importantly, Fujifilm has also confirmed its strong commitment to the new product manufacturing partnership by agreeing to a further voluntary escrow over their shares in Cynata.”

Yutaka Yamaguchi, General Manager of the Life Sciences Business Division at Fujifilm, said “Fujifilm has promoted development and manufacturing of cell therapies through collaborations with our partners, building on the strengths of Fujifilm Cellular Dynamics to produce therapeutic iPS cells in a stable and efficient way.

“The new strategic agreement builds on the partnership with Cynata to maximise the strengths and resources of both companies and further promote industrial application of iPS cell-derived regenerative medicine. We are confident that our significant, long-term investment in Cynata will reap rewards as it continues to meet its goals in developing the Cymerus technology.”

Cynata will now engage with the FDA on further clinical development of CYP-001 in the US via a Phase 2 clinical trial, an important late-stage addition to Cynata’s active pipeline, which also includes two clinical trials currently underway: the SCUlpTOR Phase 3 trial in osteoarthritis and the MEND trial in respiratory distress, with a third trial, in diabetic foot ulcers, expected to commence later this calendar year.