Tissue Regeneration Therapeutics sees rapid growth from breakthrough technology

Tissue Regeneration Therapeutics Inc (TRT) has landed a lucrative US licensing deal that could see the Toronto-based start-up become a world-leading supplier of mesenchymal stem/progenitor cells to cord blood banks around the world. The licensing deal with Stem Cell Authority Ltd, Fairlawn OH, is worth a minimum of $20 million over four years and is the second agreement TRT has concluded in the past year.

Negotiations are ongoing to secure additional licensing agreements in Australia, the Middle East, India and other jurisdictions. Last year TRT licensed the Canadian rights to CReAte Cord Blood Bank (CCBB), which could generate about $2 million in revenue. It's estimated that 3% of parents in the US and Canada bank umbilical cord blood, while in countries such as Germany it's as high as 10%. It's estimated that four million babies are born in the US annually, compared to about 400,000 in Canada.

Mesenchymal cells can also be used in cell therapy to treat auto-immune and inflammatory diseases (Crohn's juvenile diabetes, rheumatoid arthritis), cancer, heart disease and tissue engineering.

After the initial discovery but prior to the creation of TRT, the research was seed funded by the Canadian Institutes of Health Research, the Ontario R&D Challenge Fund and the Univ of Toronto. The support helped to bridge the gap between the discovery and the initial patenting.

"I'm something of a serial entrepreneur and this is the most exciting of the ventures I've ever been involved with," says Dr John Davies, TRT president, technology inventor and professor at the Univ of Toronto's Institute of Biomaterials and Biomedical Engineering. "It pushes into the area of clinical biology and transcends many boundaries."

TRT was incorporated in 2004 but was largely inactive until Davies and his team brought on Dr Jeffrey Turner as CEO. Turner is best known as the president and CEO of Montreal's Nexia Biotechnologies Inc, which developed technology to produce proteins from genetically modified goats.

"This technology is absolutely a world first. It's the gold standard for stem cells," says Turner. "Right now we're on a roll pursuing more licences … Our negotiations in the Middle East are moving very well and we could have something to announce in the next quarter."

TRT's human umbilical cord perivascular cell (HUCPVC) technology is used to remove the cells from cord tissue to be banked for future use. Davies discovered that stem cells in the connective tissue immediately surrounding the blood vessels in the cord have a frequency of HUCPV cells of approximately one in three. That compares to bone marrow with just one in 100,000. The cells are also notable for how quickly they grow into colonies.

TRT's is executing the first phase in a two-stage business plan that will see the company become profitable through licensing deals. From there, the company will seek further financing to conduct clinical trials beginning next year, initially targeting leukemia and multiple sclerosis. This phase of development is being financed by a small group of angel investors who have provided less than $1 million over the past one and a half years. A series ‘B' financing is planned to raise an additional $5-10 million.

"With Nexia, I learned that you can shoot the moon, but it takes a long time to get a program together," says Turner, who recently stepped down from the Nexia board to focus on TRT. "Our aim during the first phase is to become profitable through licensing and create a profitable company with a nice, persistent income."

In the longer term, Turner says TRT will establish a teracell world bank with potential branches in the US, Asia and Europe. TRT will own the teracell banks which will be used by parents making a cell withdrawal or physicians seeking cell matches for their patients to conduct cell-based therapy.

Turner says the intent is for TRT to remain a Canadian company, although similar intentions for Nexia failed to prevent its venture capital backers from selling most of its assets to US interests. "This is white-hot technology and there has been intense interest internationally," he says. "This company could fit well into other companies ... Right now we're developing our IP position and sponsoring medical indications for the technology."

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