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May 09, 2021 | Tom Ballard

NellOne Therapeutics awarded Phase I SBIR grant by the NSF

By Tom Ballard, Chief Alliance Officer, PYA

There’s some really good news for Knoxville-based NellOne Therapeutics Inc.

The company that is housed in the Fairview Technology Center in the Solway area of deep West Knox County has been awarded a Phase I Small Business Innovation Research (SBIR) grant by the National Science Foundation (NSF). The $250,000 will be used to conduct research and development to evaluate the therapeutic potential of NV1, a proprietary variant of the naturally occurring NELL1 protein with enhanced properties for commercial manufacturing and healing injuries in soft tissues.

Co-founded by Cymbeline (Bem) Culiat, then a scientist at Oak Ridge National Laboratory and currently the company’s President and Chief Science Officer, NellOne Therapeutics is pioneering advances in regenerative medicine to restore injured tissue to its normal functional state. The company was founded more than a decade ago and is dedicated to harnessing the power of the NELL1/NV1 protein to improve outcomes for patients around the world who suffer from significant soft tissue damage incurred in traumatic injuries or diseases.

As noted in several articles in the past year (here, here, here, and here), the executive team at NellOne Therapeutics – Culiat and Bill Malkes, the company’s relatively new Chief Executive Officer – saw potential benefits from the NV1 for those suffering health effects as a result of COVID-19 and began work in that area.

Today, NellOne Therapeutics is developing NV1 as a first-in-class biopharmaceutical to restore damaged lung tissues such as those caused by severe viral infections including COVID-19 and flu.  The fatalities in these conditions are mostly due to Acute Respiratory Distress Syndrome (ARDS) which endangers three million patients annually in the U.S. and has a high mortality rate (46 percent).

“During this pandemic, we have witnessed that when sound science and technology are developed in partnership with the U.S. federal government and other private organizations, life-saving diagnostic tests, vaccines and therapeutics are created and delivered to save millions of lives,” Culiat said in a news release. “NellOne Therapeutics is greatly honored and excited to receive this initial significant financial support from the U.S. government through NSF. Being selected for this grant after a rigorous, highly competitive peer review is an expression of NSF’s favorable assessment of the innovation and potential great impact of NVI technology in addressing a medical problem that has eluded effective solutions for decades. This research funding allows NellOne to move one step closer to improving patient outcomes by treating the severe lung tissue damage in ARDS patients.”

NellOne Therapeutics noted that despite extensive research for the past 20 years, the incidence of ARDS continues to rise and presents challenging clinical conditions to effectively manage and treat it. A recent pilot study in SARS-CoV-2 infected mice showed that NV1 increases survival by regulating and balancing the hyperinflammation and excessive response of the immune system. If successfully translated into humans, NV1 can potentially reduce ARDS-associated morbidity and prevent long/term disability in survivors.

NellOne Therapeutic’s SBIR grant is designed to validate the effects of NV1 in cultured human lung tissues and in a larger population of a mouse COVID19 model to examine further the molecular and cellular effects on lung tissues and potential gender-based differences in response to NV1 treatment.

“NSF is proud to support the technology of the future by thinking beyond incremental developments and funding the most creative, impactful ideas across all markets and areas of science and engineering,” said Andrea Belz, Director of the Division of Industrial Innovation and Partnerships at NSF. “With the support of our research funds, any deep technology startup or small business can guide basic science into meaningful solutions that address tremendous needs.”

Once a small business is awarded a Phase I SBIR/STTR grant (up to $256,000), it becomes eligible to apply for a Phase II (up to $1,000,000). Small businesses with Phase II funding are eligible to receive up to $500,000 in additional matching funds with qualifying third-party investment or sales.

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