Clinical stage biotechnology company Cynata Therapeutics has secured a manufacturing services agreement with specialised human cell manufacturing heavyweight, Fujifilm Cellular Dynamics, to produce Cynata’s Cymerus therapeutic stem cell products. The new agreement allows Cynata to leverage Fujifilm’s extensive experience in the cell therapy manufacturing space.
The current voluntary escrow conditions on Fujifilm’s 8.1 million shares in Cynata will also be extended by 12 months highlighting what the company says is Fujifilm’s long term financial commitment to Cynata.
Melbourne-based Cynata says it plans to work with Fujifilm towards shifting the manufacturing processes in place with Cynata’s current contract manufacturer, Waisman Biomanufacturing, to Fujifilm’s operations. In the interim period, Waisman will continue to manufacture Cynata products for use in current clinical trials.
The manufacturing agreement includes terms for Fujifilm to undertake technology transfer, process validation and manufacturing, under stage-by-stage, commercial, arms-length arrangements.
Prior to the manufacturing deal being finalised, Cynata made an in-principal commitment to spend US$2 million on the entire transfer process and agreed to give Fujifilm first rights to manufacture the Cymerus products.
Cynata believes Cymerus is superior to its other market competitors as it utilises a proprietary therapeutic stem cell technology that uses induced pluripotent stem cells and a precursor cell known as mesenchymoangioblast to manufacture cell therapy products. It sets itself apart from the crowd because, unlike other stem cell treatments that require multiple donors, Cymerus uses a single donor to produce cell therapy products at a commercial scale.
In addition to the strategic manufacturing agreement, Cynata recently regained commercialisation rights to its CYP-001 as a treatment for graft versus host disease, or “GvHD”.
GvHD is a serious complication that can occur after a bone marrow transplant or similar procedure where a donor’s immune cells attack the recipient of the transplant.
CYP-001 is Cynata’s lead product and has met all clinical endpoints with regards to safety and efficacy data for the treatment of GvHD in its phase 1 trial. Planning for a phase 2 clinical trial in GvHD is presently underway.
Cynata sees CYP-001 as filling a gap in the market given the only other approved treatment currently on the market is corticosteroid therapy that is effective in only 50 per cent of patients.
Clinical trials of Cymerus products treating osteoarthritis and in patients with respiratory failure are currently ongoing.
Additionally, the company says it has demonstrated utility of its Cymerus technology in preclinical models of numerous diseases including asthma, heart attack, sepsis, acute respiratory distress syndrome and cytokine release syndrome.
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.
With a strategic manufacturing deal in the bag, Cynata can now focus its efforts on taking its Cymerus platform successfully through its phase 2 clinical trials in addition to furthering a series of other prospective ventures in the lucrative biotechnology space.
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