Ongoing studies of Cynata Therapeutics Cymerus stem cell products are beginning to reveal a wide range of commercial possibilities for the ASX-listed companys cutting edge biotechnology that it is looking to apply to a multitude of ailments from the treatment of osteoarthritis and heart attacks through to COVID-19.

In its most advanced trials to date, Cynata will soon embark on a Phase 3 trial of its CYP-004 product, the companys mesenchymal stem cell or MSC product developed to treat osteoarthritis. The 448 person trial is being sponsored by The University of Sydney and will be funded by a project grant from the Australian Government National Health and Medical Research Council.

The company is also progressing on multiple other fronts developing a range of Cymerus MSC therapeutics with the CYP-001 product being another lead candidate. CYP-001 is being developed to treat acute graft-versus-host disease, or GVHD an affliction suffered by bone marrow transplant recipients. GVHD can develop from donated bone marrow that does not take well to a recipients body which triggers an immune response, attacking the host.

Presently, GVHD is treated with steroid therapy however sufferers tend to have a very low survival rate, with less than 20 per cent of patients living for more than two years and few alternate treatment pathways are available.

This looks set to change following Phase 1 trial of Cynatas CYP-001 product on a cohort of patients which saw the survival rate of sufferers of GVHD triple to 60 per cent over a two-year period. The company is now moving CYP-001 into Phase 2 testing and towards commercialisation with partner and shareholder, Fujifilm Corporation.

The matchup with the Japanese-based multi-national is already paying dividends with Cynata receiving an upfront US$3 million payment with further staged payments and royalties to follow in a licensing deal potentially worth more than US$50 million in the longer term.

Stem cells are the building blocks of the human body - essentially the cells from which all other cells are derived and under the right conditions, they can divide to produce more cells sometimes known as Daughter cells. These Daughter cells can become new stem cells or more specialised cells such as blood, bone or even the cells that make up brain or heart tissue.

When appropriately manipulated, stem cells have the potential to treat a range of diseases and aid in the healing and recovery of patients suffering both disease and trauma.

There are a limited number of sources of stem cells - embryonic stem cells, perinatal stem cells and adult stem cells.

Embryonic stem cells are thought to be the most useful and versatile but only harvestable in very small quantities. Perinatal stem cells found in amniotic fluid and umbilical cord blood are also only harvestable in limited quantities although their potential is yet to be fully understood.

Adult stem cells, found in bone marrow or fat, were previously thought to be only useful in producing a limited range of specialised cells with multiple donors required to generate practical amounts of therapeutical medicines.

However, ongoing research shows that by utilising a form of genetic reprogramming, mature cells can be re-programmed to behave like embryonic stem cells. These manipulated cells are called induced pluripotent stem cells, or iPSCs which is where Cynatas Cymerus technology comes into the picture.

Cynatas proprietary Cymerus technology uses iPSCs and a precursor cell called a mesenchymoangioblast to manufacture MSC therapies at a commercial scale without the need for multiple donors. This is where the Cymerus platform diverges from similar therapies, doing away with the need for multiple donors and overcoming a bottleneck in the generation of its product.

Other Cynata MSC products in development include a therapy to assist in the treatment and recovery of heart attacks, which is also showing promise according to the company. Another Cynata product undergoing pre-clinical trials with potential application in the treatment of lung disease is idiopathic pulmonary fibrosis, or IPF. Cynatas research in lung diseases has an unexpected spin-off in that its MSCs may assist in a patients recovery of COVID-19 according to the company. This application is being pursued in a clinical trial in COVID-19 patients presently being conducted in NSW.

These latest results with Cymerus MSCs add to the large body of evidence on the potency of these cells and their potential utility in treating a wide range of devastating diseases. IPF represents an enormous unmet medical need, as existing treatment options have only modest effects on disease progression and survival rates.

Cynatas is now modelling potential MSC therapies to treat various other afflictions too including critical limb ischemia, asthma, sepsis, cytokine release syndrome and diabetic wounds.

In the world of biotechnology, you really only have to produce one winner to attract a longing stare from the big biotechs who can swallow you whole with their massive cheque books with a range of targets and opportunities in its armoury that look to be developing well, dont be surprised if Cynata eventually disappears under the giant footprint of one of the big biotechs.

Is your ASX listed company doing something interesting? Contact: matt.birney@wanews.com.au

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Cynata looking to revolutionise stem cell therapy - The West Australian