NellOne Therapeutics Inc., the early stage biopharmaceutical company using a talented protein to plot a new future for regenerative medicine, today announced that the United States Patent and Trademark Office (“USPTO”) yesterday issued U.S. Patent No. 10,752,663 with key composition claims to the company’s novel variant of the NELL1 protein, transforming the company’s ability to commercialize its pioneering science.
The utility patent, Methods and Compositions for Regenerating Tissues, protects the company’s breakthrough work on a shorter version (NV1) of the naturally-occurring NELL1 protein. Importantly, NV1 has higher efficacy in soft tissue healing, as well as improved biological properties which make its manufacture easier and more cost effective. The USPTO decision enables the company to accelerate its efforts to develop multiple clinical applications for NV1, with a view to large scale production to treat acute major injuries in tissues such as skeletal muscle, the heart and the lung.
This patent is the first intellectual property owned by NellOne Therapeutics, and is added to a robust portfolio of 20 NELL1-based patents licensed from UT-Battelle. This is the latest in a rapid series of decisive steps forward for the business over the last seven months. NellOne Therapeutics is moving aggressively from scientific development to the marketplace with current and new partnerships.
“This patent solidifies NellOne’s place in the highly competitive field of regenerative medicine,” said NellOne Therapeutics CEO William Malkes. “We are seeing yields of NV1 that are five times higher than the naturally occurring NELL1 protein, which will support significant cost reduction in future therapeutic uses. We are continuing to improve large-scale production and quality of the protein to further bring down costs and enhance efficacy to enable various formulations for different clinical scenarios.”
Cymbeline Culiat, CSO and the inventor of the NV1 novel variant, remarked: ”The issuance of this patent is a huge and timely milestone in NellOne’s journey to create NELL1-based drugs and devices that can revolutionize regenerative medicine. We are using NV1 to address life-threatening conditions in large patient populations, including respiratory tissue failure in COVID-19 patients. Optimizing both the manufacturing and efficacy of NV1 are essential to our success, and this patent is an important step in that journey.”
NellOne Therapeutics is also pursuing claims to methods of treatment using NV1, particularly for treating muscle atrophy or wasting, such as cachexia in late stage cancer or muscle loss due to immobility. Claims to the use of NV1 in treating lung and heart damage induced by viral infections including COVID-19 were filed in a separate provisional application. The expanded IP portfolio is opening up potential new partnerships or licensing opportunities.
NELL1 promotes tissue regeneration post-injury by regulating processes in the extracellular matrix (the complex molecular environment surrounding cells) to prevent excessive inflammation, increase stem cell recruitment, trigger blood vessel formation and facilitate tissue growth and maturation. This treatment approach restores both tissue architecture and function, thereby mitigating long-term disability, improving patient quality-of-life, and reducing burdens on the healthcare system.
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Dylan Jones
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