Stem cells are believed by many to be the future of medicine, offering potential treatments for major diseases like cancer, Parkinson’s disease, heart disease, and osteoarthritis.
While there are a host of stem cell specialists around the globe, only a handful of listed Australian biotechs are tackling the therapy head on.
So which companies come under this banner? And what regenerative medicines are they working on?
Sydney-based biotech, Regeneus (ASX:RGS), is focused on discovering treatments for osteoarthritis and other musculoskeletal disorders, as well as oncology, dermatology and chronic pain.
Regeneus has partnered with The Asahi Glass Co. for the exclusive rights to use its Progenza platform for the manufacture of mesenchymal stem cells (MSCs) for clinical applications in Japan.
Progenza is an allogeneic off-the-shelf stem cell technology platform that uses stem cells derived from adipose-tissue for the treatment of osteoarthritis and other musculoskeletal diseases.
Regeneus is also in the advanced stages of discussion with another Japanese partner for the clinical development and commercialisation of Progenza in Japan and has advised it anticipates entering into an agreement in the second half of FY19.
The company achieved positive Phase 1 results for its RGSH4K product, its immunotherapy treatment designed work in combination with chemotherapy to treat lymphoma.
It has also recorded positive pre-clinical results for its Sygenus product which uses cell secretions from MSCs as a topical application for the treatment of inflammatory skin conditions such as acne and wound healing.
In addition to its human treatments, Regeneus is developing canine treatments for osteoarthritis and an immunotherapy to work in combination with chemotherapy to treat canine lymphoma.
Cynata (ASX: CYP) is the second largest ASX-listed stem cell specialist in Australia.
With a market capitalisation of over $150 million (at the time of writing), the Melbourne-based company is best known for developing its therapeutic stem cell platform technology Cymerus.
The platform is used for manufacturing mesenchymal stem cells (MSCs) and is able to do at virtually limitless quantities – all whilst maintaining potency and consistency. This ability makes it products highly applicable in therapeutic applications.
Its first product, CYP-001, was used in phase 1 trials for the treatment of graft-versus-host-disease (GvHD), a life-threatening complication that can occur following a blood stem cell or bone marrow transplant.
The phase 1 clinical trial completed with very positive results – 87 percent of patients reported an improvement in severity by at least one grade compared to baseline and 53 percent were reported to have had their symptoms completely resolved.
Cynata has also partnered with Japanese firm Fujifilm for the product development for CYP-001 who will fund the Phase 2 clinical trial in 2019.
The company is also reviewing other applications for the Cymerus technology, namely treatments for critical limb ischemia, asthma, heart attacks, diabetic wounds and brain cancer.
This year it will begin a further phase 2 clinical trial with the University of Sydney for the treatment of osteoarthritis. The trial will enrol 448 patients – making it one of the largest stem cell trials in the world.
Founded in 2014, Orthocell (OCC) is one of the younger stem cell companies on the ASX.
The Perth-based company is developing innovative treatments for people suffering from tendon, cartilage and soft tissue injuries.
It has two products that are regenerating mobility for patients. One is a collagen based medical device – CelGro – the other is a cellular therapeutic approach for the regeneration of human tendon tissue – Ortho-ATI (Autologous Tenocyte Implantation).
CelGro has secured approval for sales in Europe and Orthocell is now eyeing the US and Australia for market entry, with the technology receiving particularly strong interest from the dental market.
Orthocell’s other product, Ortho-ATI, has treated over 500 patients and clinical data published in peer reviewed journals, confidently demonstrates the therapy reduces pain and repairs tendons.
Orthocell also has a research collaboration in place with Johnson and Johnson which is generating additional partner interest.
Mesoblast (ASX:MSB), is by far the largest and perhaps most well know stem cell biotech on the ASX. It has been in operation since 2004 and has a market cap of nearly $600 million (at the time of writing).
In 2018, the share price peaked at $2.34 per share in October, then dropped to a low of $1.03 in December.
The dramatic fall in the share price was the result of a failed phase 2 trial in end-stage heart failure patients implanted with a left ventricular assist device (LVAD) which missed its primary endpoint.
The trial showed that Mesoblast’s stem cells don’t work for the endpoint cited. However, it did achieve significant reduction in major gastrointestinal bleeding and related hospitalisations.
This is a complication affecting up to 40 percent of LVAD recipients and the US FDA recognises it as clinically meaningful outcome.
The company is at different stages of advancement with different applications of its stem cell treatments. Mesoblast have two commercial products in market via partners in Japan and Europe, as well as a handful of phase 3 products targeting chronic heart failure, and chronic lower back pain due to degenerative disc disease.
Each of these Australian biotechs are contributing to the advancement of stem cell therapies. While some are closer to being publicly available, the promising results being achieved indicate stem cell therapies are the future of regenerative medicine.
In 2017, the global stem cell therapy market was valued around US$1,328 million and revenues for the sector are forecasted to reach close to US$4,760 billion by 2024 – indicating that there is more than ample space for more than once player in the sector for each to have a large slice of the pie.
Star Investing may have commercial relationships with the companies mentioned in this article. This content does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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