NellOne Therapeutics


NellOne is an early stage biopharmaceutical company pioneering advances in regenerative medicine. Its mission is to relieve suffering and restore lives by returning damaged soft and hard tissue to its pre-injury state, utilizing the NELL1 protein to promote tissue regeneration, control inflammation, and improve patient outcomes. The company is dedicated to harnessing the power of the NELL1 / NV1 protein to improve outcomes for patients worldwide suffering from significant soft tissue damage due to traumatic injuries or diseases. NellOne is also actively involved in research supported by the National Science Foundation to evaluate the therapeutic potential of NV1, a proprietary variant of NELL1, for treating lung tissue damage such as that caused by severe viral infections like COVID-19 and flu.

Industries

biotechnology
health-care
therapeutics

Nr. of Employees

small (1-50)

NellOne Therapeutics

Knoxville, Tennessee, United States, North America


Patents

Methods and compositions for regenerating tissues

US-12281144-B2

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Methods and compositions for regenerating tissues

US-11891424-B2

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Methods and compositions for regenerating tissues

US-11667684-B2

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Methods and compositions for regenerating tissues

US-11034741-B2

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Methods and compositions for regenerating tissues

US-10752663-B2

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Products

Engineered recombinant signaling protein therapeutic candidate

A shortened, engineered recombinant variant of a developmental matricellular signaling protein developed to reduce inflammation and promote regeneration of soft and hard tissues; described as having improved functional effects and higher production yields versus the native protein. Preclinical work includes cultured human lung tissue studies and pilot SARS‑CoV‑2 mouse studies assessing survival and lung repair.

NELL1

NELL1 plays a critical role in early bone formation, repair after injury, and degenerative diseases such as osteoporosis. It is a protein used as a potential regenerative therapy platform for bone and cartilage injury and related conditions.

NELL1 protein therapeutic

A therapeutic protein candidate developed by NellOne Therapeutics for treating tissue damage and inflammation resulting from respiratory viral infections including COVID-19, promoting tissue regeneration and immune system balance.

NV1

NV1 is a patented variant of neural epidermal growth factor-like (NELL1) protein being commercialized by NellOne for unmet inflammatory lung health market needs and licensing partnerships. It promotes new tissue formation and maturation by regulating the composition of the extracellular matrix, aiding in healing, balancing hyperinflammation, and promoting regeneration in post-injury tissue damage.

NELL-1

NELL-1 is a therapeutic agent critical for early vasculature and cardiac tissue formation, shown to help overcome cell death in cardiomyocytes under hypoxic conditions and during Acute Myocardial Infarction (AMI).


Services

License inbound technologies and form collaborative research partnerships with national laboratories, contract developers, and assay providers to accelerate development and access specialized platforms.

Collaborative development of preclinical studies and specialized assays to evaluate efficacy, optimize formulations, and support regulatory filings.

Management and execution of SBIR-funded preclinical research programs, including evaluation in cultured human tissues and animal infection models to generate translational data for regulatory and development milestones.

Expertise Areas

  • Regenerative medicine and tissue engineering
  • Recombinant protein therapeutic development
  • Preclinical translational development for respiratory and musculoskeletal injuries
  • Nanoparticle and targeted drug delivery research
  • Show More (5)

Key Technologies

  • Recombinant protein therapeutics
  • Protein engineering for improved yield and manufacturability
  • Organotypic cultured human lung tissue models
  • In vivo viral infection animal models (SARS‑CoV‑2 mouse models)
  • Show More (4)

News & Updates

NellOne Therapeutics of Knoxville, Tenn., has licensed a drug delivery system from Oak Ridge National Laboratory designed to transport therapeutics directly to cells infected by SARS-CoV-2, the virus causing COVID-19. The technology embeds the virus's spike protein into nanoparticles to target infected cells, potentially reducing viral replication and minimizing drug toxicity.

NellOne Therapeutics announced the filing of a provisional patent application for the use of the NELL1 signaling protein in treating respiratory viral infections including COVID-19. The patent details methods to reduce tissue damage and inflammation caused by the virus, leveraging NELL1's tissue regeneration properties.

NellOne Therapeutics received U.S. Patent No. 10,752,663 for its novel variant of the NELL1 protein, NV1, which has higher efficacy and is easier to manufacture. This patent supports the development of large-scale therapeutic applications for tissue regeneration in various tissues.

William A. Malkes, founder of GRIDSMART Technologies, was appointed CEO of NellOne Therapeutics. He has a successful track record in technology and healthcare, and his leadership marks a transition from research to commercial exploration of NELL1-based regenerative products.


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