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:
- Ready-to-inject formulation for better clinical trial enrollment
- Elimination of dose preparation reducing prep time from 24 hours to 30 minutes
- Tenfold to twentyfold increase in production scale and 50%-75% reduction in product impurities
- Development of 12 new analytical and functional methods for in-process quality control
- Elimination of animal-based production reagents
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.
Copyright © 2020 scienceboard.net