Cynata achieves world-first MSC breakthrough
Cynata Therapeutics (ASX:CYP) has achieved a world-first breakthrough of manufacturing mesenchymal stromal cells (MSCs) to therapeutic standards using induced pluripotent stem cells.
The company has successfully validated its method of consistently and efficiently manufacturing MSCs using the stem cells during testing at Waisman Biomanufacturing in the US.
Induced pluripotent stem cells are an effectively limitless starting material, unlike other methods of producing MSCs, which require a continuous supply of new tissue donations.
Cynata expects to be able to produce all the MSCs it will ever need using a single bank of the pluripotent cells derived from a single blood donation.
This method will potentially eliminate the need to source, screen and test donors, as well as issues related to donor-to-donor variability.
MSCs are found in the bone marrow and connective tissue. They have immunosuppressive and immunoregulatory activity, and migrate to sites of affected tissue to control local inflammation.
The company now plans to move to manufacture GMP-grade MSCs for clinical trials of its Cymerus treatment candidate. A phase I trial of the cells in graft vs host disease (GvHD) is currently at the planning stage, and the company recently appointed a CRO to help design the trial.
GvHD is a potential complication of bone marrow transplants, occurring when the immune cells in the donor material attack the recipient’s tissues. It is commonly treated by steroids, but if unsuccessful is usually fatal.
Cynata CEO Dr Ross Macdonald called the development a “critical milestone” for the company.
“An equity research report compiled last year by respected biotech analyst Stuart Roberts saliently noted that should Cynata demonstrate an ability to make cells at industrial scale under GMP then it would be in a position to be a ‘genuine Stem Cell Revolutionary’,” he said.
“We have just achieved this important goal. Our novel method of manufacturing stem cells - the Cymerus technology - allows for virtually unlimited quantities of MSCs of consistent quality to be manufactured for therapeutic use.”
Cynata Therapeutics (ASX:CYP) shares were trading 75.6% higher at $0.72 as of around 12.30 pm on Thursday.
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