NellOne CEO’s update cites a number of significant accomplishments

NellOne(EDITOR’S NOTE: After this article was finalized, NellOne Therapeutics learned that it had been invited to present at the North Carolina Biotechnology Center’s “Ag Biotech Entrepreneurial Showcase” set for May 19 in Research Triangle Park.)

By Tom Ballard, Director of Innovation and Entrepreneurial Initiatives, Pershing Yoakley & Associates, P.C.

In a recent update to stakeholders, Tracy Warren, Co-Founder and Chief Executive Officer (CEO) of NellOne Therapeutics, provided a progress report on the Oak Ridge-based company that we profiled in a two-part series in late 2013 (Part 1 and Part 2).

NellOne was founded in 2008 based on the work of then Oak Ridge National Laboratory scientist Bem Culiat. Today, the researcher turned entrepreneur is Chief Scientific Officer for the company that, like many start-ups, has pivoted in its initial market focus.

Those pivots have produced the solid progress that Warren cited in her year-end report.

“NellOne’s business continued to evolve and mature this year (2014), and Bem and I believe it builds on the foundation for a meaningful future for the company,” she said.

In her update, Warren cited a number of significant steps in the previous 12 months. They included completion of NellOne’s first large animal wound healing study and continued strong support from the company’s partner in protein production as well as ORNL.

A team of researchers and veterinarians at the Large Animal Clinical Sciences, University of Tennessee’s College of Veterinary Medicine (UTCVM) in Knoxville conducted the 42-day study of wound healing in eight horses.

Although this milestone large animal study on the wound healing properties of the NELL1 protein was on body wounds, the ultimate direction of the company was reiterated by the CEO.

“Our ultimate product development focus is on extremity wounds which cause lameness or even death in performance horses,” Warren said. “We believe that adding NELL-1 to the standard of bandaging care for such wounds helps accelerate the healing process in horses so they can return to the pasture and an active life.”

She added that two forms of equine NELL-1 protein– one full-length and the other a smaller variant form – were tested.

“There were no adverse effects observed on the health and behavior of the horses, thus demonstrating the safety of our product in large animals,” Warren said.

Based on these results, NellOne plans to transition to a more severe injury model, in part because severe limb injuries constitute the biggest market for regenerative medicine products in the equine industry. These types of acute injuries can also be career ending for high performance horses, even resulting in death or euthanasia.

More importantly, the CEO said the biology of the NELL-1 protein addresses several of the challenges in limb wounds such as difficulties in regenerating the vasculature or blood vessel network (angiogenesis).

Warren thanked the UTCVM research team – Drs. David Anderson, James Schumacher, Madhu Dhar and Christopher Caniglia – as well as Dr. Wilber Huang and the Abnova Corporation, its partner in protein production

“Abnova scaled its manufacturing efforts of both NELL-1 full-length and NELL-1 variant at rates we needed to eventually reach our target,” Warren said. Abnova significantly scaled up the levels of protein production to match the increased requirements for a large animal study and in preparation for achieving commercially relevant amounts.

“Abnova has been an amazing partner to NellOne for many years and remains committed to support us through studies in 2015 and ultimately GMP production,” she said.

There was also good progress on the all-important intellectual property front.

  • Patents on the veterinary and human clinical applications of the NELL-1 protein in wound healing and heart tissue regeneration have now issued in seven countries.
  • The cardiovascular patent issued in the U.S., Japan and Australia in 2014, with patents pending in Israel and Canada. This patent has already issued in Germany, France and the United Kingdom in 2013.
  • NellOne’s wound healing patent also issued last year in Australia, with pending action in Canada, Japan and the European Union. It was previously issued in the U.S. and Israel (2013).

As far as ORNL, Warren noted that the lab “continues to support the company as we move toward commercialization of a product for animals now and humans later.”

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