NewcelX Secures Brazilian Patent For NCEL-101 Manufacturing Technology Ahead Of Clinical Development

NewcelX Ltd., a clinical-stage regenerative medicine company focused on developing stem cell-derived therapies, has announced that the Brazilian Patent and Trademark Office has granted Patent Number BR 112018010946-0 for its proprietary cell selection and enrichment technology. The newly issued patent protects the manufacturing process used to produce the company's lead investigational therapy, NCEL-101, and will remain in effect until November 2036.

The patent strengthens NewcelX's intellectual property portfolio by securing protection for its core manufacturing technology in Brazil, one of the largest markets for type 1 diabetes in Latin America. The company believes this milestone will support its long-term commercialization strategy while enhancing opportunities for future collaborations and partnerships as NCEL-101 continues to advance through clinical development.

Ronen Twito, Chief Executive Officer and Executive Chairman of NewcelX, said the patent approval follows the company's recently completed successful Type B Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA). During that meeting, the FDA provided guidance supporting the planned clinical development of NCEL-101 in combination with Eledon's anti-CD40L monoclonal antibody, tegoprubart, for the treatment of type 1 diabetes. According to Twito, the positive regulatory feedback established a clear pathway for initiating future clinical trials.

He also highlighted the commercial importance of Brazil, noting that approximately 500,000 people in the country are living with type 1 diabetes, with disease prevalence continuing to increase at an estimated annual rate of 4.4%. Twito said securing patent protection in this growing market reinforces the company's global intellectual property strategy, strengthens its competitive position, and supports future business development opportunities as NCEL-101 progresses toward clinical testing.

NCEL-101 is being developed using NewcelX's proprietary cell selection and enrichment technology, which is designed to isolate highly functional pancreatic islet cells from a larger population of stem cell-derived islet-like cells. By enriching only the clinically relevant cells, the company aims to maximize therapeutic effectiveness while minimizing the number of cells required for treatment.

According to preclinical research, NCEL-101 has demonstrated several promising characteristics. Approximately 60% of its beta cells simultaneously express insulin and NKX6.1, two important markers associated with healthy insulin-producing cells. The therapy also shows expression of MAFA, a transcription factor that plays a critical role in the maturation of beta cells and their ability to release insulin in response to glucose.

The enriched cell population consists of approximately 99.98% endocrine lineage cells, indicating that the product contains very few, if any, unwanted non-endocrine cells. In addition, more than 96% of the cells are non-proliferative, closely resembling naturally occurring human donor islet cells. These characteristics support the company's goal of developing a safer and more effective cell therapy for patients with type 1 diabetes.

NewcelX believes its proprietary enrichment process differentiates NCEL-101 from other stem cell-based therapies by selectively isolating functional islet cells that are most relevant for clinical use. This approach is intended to improve therapeutic outcomes while allowing treatment with lower cell doses.

The company also recently completed a successful Type B Pre-IND meeting with the FDA, an important regulatory milestone that supports the continued development of NCEL-101. The planned clinical program will evaluate the therapy in combination with Eledon's anti-CD40L monoclonal antibody, tegoprubart, as a potential treatment for type 1 diabetes. With both regulatory progress and expanded patent protection, NewcelX believes it is well positioned to advance NCEL-101 into clinical development.