December 8, 2020 -- Lineage Cell Therapeutics has provided an update for its OPC1 cell therapy program, an oligodendrocyte progenitor cell (OPC) transplant for the treatment of acute spinal cord injuries.
The company reported an improved differentiation process which results in improvements in production and quality of the drug product. OPC1 has been evaluated in the SciStar open-label, 25-patient, single-arm phase I/II clinical trial.
OPCs are naturally occurring precursors to the cells that provide electrical insulation for nerve axons in the form of a myelin sheath. The OPC1 program has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine. The drug candidate has received regenerative medicine advanced therapy designation and orphan drug designation from the U.S. Food and Drug Administration.
The new manufacturing improvements include:
The company plans to file patent applications on the process and product. The same processes will be used in its future immune-oncology platform, according to the company.