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November 08, 2020 | Tom Ballard

NellOne Therapeutics utilizes ORNL’s “COVID-19 Rapid Access Licensing Program”

The novel coronavirus is no doubt top of mind for most people with the infection numbers rising rapidly on a daily, so an announcement last week from Oak Ridge National Laboratory (ORNL) that involves a local early stage biopharmaceutical company should be of great interest and importance.

Knoxville-based NellOne Therapeutics Inc. has taken advantage of ORNL’s “COVID-19 Rapid Access Licensing Program” to take a year to assess the viability of incorporating a drug delivery system developed at the lab to address COVID-19. It will be connected with other work that the company is undertaking.

“We have a long history of cooperating with ORNL,” said Bill Malkes, Chief Executive Officer of NellOne. Cymbeline (Bem) Culiat, the company’s Co-Founder and Chief Scientific Officer, was the ORNL researcher who discovered NELL1, a matricellular signaling protein expressed in a variety of human tissues.

“When I learned of the lab’s special licensing arrangement, I looked at the portfolio that was available,” Malkes said. The one of greatest interest was a technology developed by Chris Ellis, a Computational Microbiologist in ORNL’s Biosciences Division. It is a concept that could transport therapeutics directly to cells infected by SARS-CoV-2, the virus causing COVID-19.

According to ORNL’s news release, Ellis’ concept calls for embedding the SARS-CoV-2 spike protein into nanoparticles such as liposomes, allowing them to carry drugs only to infected cells. Through the spike protein mechanism, nanoparticles can then bind to the cell’s protein receptor and pass their contents through the cell membrane, inhibiting viral replication.

“This has some great potential synergies,” Malkes said, adding, “There’s a lot of work and collaboration ahead. NellOne’s efforts are focused on delivering our NV1 therapeutic to the lung.  Dr. Ellis’ technology has potential in creating an even more purposely directed targeted delivery” That work will draw on another partnership that NellOne has with researchers at the Bethesda, MD-based Uniformed Services University of the Health Sciences (USU). The effort was spotlighted in this recent article.

“Through that relationship, we have access to world class scientist like ORNL, but with different skill sets.  We are exploring aerosolizing the platform with our other work,” Malkes said. The fact that NellOne could execute a royalty-free, non-exclusive license for one year made the exploration financially feasible for a start-up.

As Ellis said in the ORNL news release, “We’re still in the very early stages of investigating this concept, and it requires much more investigation. Yet, the principle behind it is that you deliver your drug on target instead of flooding the entire human body, which then eliminates or minimizes any drug toxicity and enhances efficacy.”


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