Regeneus (ASX: RGS) will team with the world's largest manufacturer of stem cells, US$5.4 billion market-capped Swiss company Lonza Group AG to manufacture CryoShot® Canine for dogs in the U.S for an FDA trial.
The tie-up is expected to see Regeneus' shares open stronger today and also lead to a faster path to U.S. FDA registration and ultimately to commercialisation and revenues through the partnership with Lonza.
Regeneus, the regenerative medicine company developed CryoShot Canine, which is an off-the-shelf allogeneic cell therapy product for the treatment of musculoskeletal conditions in dogs.
Lonza is a global manufacturer with specialist experience in manufacturing stem cells to the quality standards that the U.S. and European regulators require for product registration.
The cells will be manufactured at the Lonza facility in Walkersville, Maryland and then distributed to the participating trial veterinarian clinics.
"It is very exciting to be partnering with Lonza, a global manufacturer with specialist experience in manufacturing stem cells to the quality standards that the US and European regulators require for product registration", said Dr Duncan Thomson, Head of Veterinary Health at Regeneus.
"We view this as the start of a long-term relationship in which Lonza will manufacture CryoShot for the world wide canine market.
Our clinical trial work in Australia has been rewarding and it is now time to begin registration of the CryoShot product in the US and European markets."
CryoShot Canine Caccine
The vaccine is currently under pre-registration trial in Australia and has been through pre-clinical testing at the Kolling Institute in Sydney.
The testing demonstrated that it could induce remission or significantly slow tumour growth in an aggressive glioma animal model.
The vaccine involves removal of a tumour or biopsy from the dog in order to produce a personalised vaccine. This use of the dog's own tumour proteins as the source of the biological therapy has cleared the way for faster approval and commercialisation.
Regeneus gained approval for its canine cancer vaccine to move to commercialisation in the U.S. in November 2013.
The CryoShot Canine cell therapy is produced from a small amount of adipose (fat) tissue derived from a donor animal. The tissue is processed and cultured to isolate and increase the regenerative cells before being cryogenically frozen and stored in liquid nitrogen.
The vaccine involves removal of a tumour or biopsy from the dog in order to produce a personalised vaccine. It is delivered to veterinary clinics cryogenically frozen and then thawed for injection by the treating veterinarian.
About Lonza Group
Lonza was founded in 1897 in the Swiss Alps, Lonza today is one of the world's leading life sciences companies with more than 40 manufacturing and R&D facilities and 10,000 employees worldwide. The company is organized into two market-focused segments: Pharma&Biotech and Specialty Ingredients.
This is another value accretive partnership for Regeneus, teaming with Lonza Group to manufacture CryoShot Canine cell therapy product for U.S. FDA trial.
We consider the partnership an accelerated pathway to make Regeneus' autologous vaccine available to treat dogs with life threatening cancerous tumours in the U.S.
With cancer accounting for almost half of the deaths of pets over 10 years of age, the therapy provides a large market and a significant prize for Regeneus' cancer vaccine.
Regeneus holds an exclusive worldwide licence for commercialisation of the technology for veterinary applications - and an option over all human applications as well.
In Proactive Investors' view, Regeneus is at the forefront of a massive growth in the regenerative medicine and cell technology industry, currently in its infancy. The current share price of $0.49 is light in line with upcoming catalysts.
On our initial estimates of milestones and growth projections, Proactive Investors has initiated a preliminary share price target of $0.78 - $0.93 within 12 - 18 months for Regeneus.
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