This article is taken from our animal health platform dated10/06/20.
Established in 2002, VetStem Biopharma has become the leadingproponent of regenerative medicine for companion animals in the US.Animal Pharm editor Joseph Harvey spoke to the company's founderand chief executive Robert Harman about how stem cells will becomean embedded part of the US pet care sector.
VetStem Biopharma was the first business in the US to provide anadipose-derived stem cell service to veterinarians for companionanimals.
The firm provides its stem cell service to treat traumatic anddegenerative diseases - such as bowed tendons, ligament injuries,osteoarthritis and osteochondral defects - in horses, dogs andcats.
VetStem pioneered the use of autologous veterinaryadipose-derived stem cells in 2003, when the first horse wassuccessfully treated with its technology for a tendon injury thatwould normally have been career-ending. In 2004, the service waslaunched for use in horses.
The next milestone for the firm was in 2007, when it expandedinto stem cell therapy for dogs and cats with osteoarthritis andorthopedic soft tissue injuries. To date, over 17,000 veterinarypatients have now been treated with VetStem's cell processingtechnology.
VetStem has been educating veterinarians on the benefits of itsservices since 2003, which the company believes has led to stemcells becoming more accepted as a treatment modality.
In 2015, Dr Harman told Animal Pharm how stem cellswere an emerging therapy in the veterinary mainstream in the US.Five years down the line, he pointed out "veterinary stem celltreatments are now available at nearly every veterinary school butprincipally in research studies".
Five years ago, less than 10% of vets had administered a stemcell therapy. Now, Dr Harman claimed this figure had risen to about25% "or perhaps higher when you include products likeplatelet-rich-plasma treatments".
He said VetStem has seen a broadening of the type of proceduresits stem cells are being used for over recent years. The firm hasnow provided stem cell therapies to over 34 species (includingexotic animals) and cells for treatment of more than 44 differentdiseases. Key new diseases include feline stomatitis, inflammatorybowel disease, renal failure and back pain.
He said public awareness and acceptance of veterinary stem cellshas very much improved over the last five years.
"The stigma of embryonic stem cells has faded and there are nowglobally a number of exciting, new and approved human stem cellproducts that show the promise is reality," Dr Harmanexplained.
VetStem holds exclusive licenses to more than 70 patentsincluding worldwide veterinary rights for use of adipose-derivedstem cells. It is investigating stem cell therapy forimmune-mediated and inflammatory diseases, as well as organ diseaseand failure. Recently, VetStem entered the pet cancer space afterreceiving an exclusive license to an immunotherapy from CalidiBiotherapeutics.
Unique offering
VetStem said there are currently no other firms in the US thatoffer an autologous central laboratory service for veterinary stemcell therapies.
"It is difficult to do and requires considerable expertise inlogistics," Dr Harman noted. "Most pharma prefer an off-the-shelfmodel. We will have off-the-shelf products but feel this servicemodel was the right choice from a safety standpoint.
"Prior to VetStem, we operated two large medical servicebusinesses and developed the ability to deliver services at anaffordable cost, while meeting regulatory standards. We will beexpanding the range of products and digital services in comingmonths and years to meet the needs of the practicingveterinarian."
Landmark ahead
The next big landmark for VetStem and the wider US veterinarystem cell sector will be the firm's debut US FDA authorization.
VetStem expects its first product - a canine osteoarthritistherapy - to secure FDA approval within the next 24 months. Thefirm is currently in final phase III testing of this productcandidate.
In 2019, Belgian business Global Stem Cell Technology (GST)gained marketing approval for the first EU veterinary stem cellproduct. The firm's Arti-Cell Forte, which is for the reduction ofmild-to-moderate recurrent lameness associated with non-septicjoint inflammation in horses, is marketed by Boehringer IngelheimAnimal Health.
Dr Harman said GST's landmark approval in the EU will helpVetStem's ongoing regulatory processes with the FDA.
"It shows the regulators understand cell therapy much better andare following human counterparts in the approval process," henoted. "The FDA has become very educated on cell therapy. Theregulators attend almost every major stem cell meeting, includingthe veterinary meetings."
Dr Harman said he still retains the opinion that veterinary stemcell products can become future animal health blockbusters (withannual sales of around $100 million or higher) as "they have agreat safety profile and can be used across a spectrum ofdiseases".
According to a report by MarketWatch, the global animal stemcell therapy space was valued at $16m in 2018 and is expected toreach $200m by the end of 2025 - growing at a compound annualgrowth rate of around 37% between 2019 and 2025. The research firmsaid the US is the largest consumption region of animal stem celltherapies and accounted for nearly 59% market share in 2017.
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