California-based biotech Lineage Cell Therapeutics announced this week that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance granting the company’s patent application for proprietary manufacturing processes for its spinal cord injury cell therapy candidate.
According to the recent statement, the company’s current focus is to meet with the FDA this quarter to discuss its Investigational New Drug (IND) amendment submission for OPC1, which has already received regenerative medicine advanced therapy (RMAT) and Orphan Drug designations. The treatment uses oligodendrocyte progenitor cells, naturally-occurring precursors, to the cells that provide electrical insulation for nerve axons in the form of a myelin sheath.
Cell and gene therapies have grown exponentially in the last five years, with experts estimating that the industry could have as many as 10 to 20 new therapies approved every year starting in 2025.
Lineage Cell Therapeutics — formerly known as BioTime — rebranded in 2019. The company's CEO, Brian Culley, explained that the new patents highlight the company’s capabilities to develop differentiated cell types from undifferentiated pluripotent cells. “The production of specific cell lineages in a controlled and reproducible manner, on platforms which can support large-scale clinical trials, provide us with an important competitive advantage.”
