Lineage Cell Therapeutics Inc (NYSEAMERICAN:LCTX) recently provided an interim update of the results from the Phase 1/2a clinical trial of OpRegen as a potential treatment for dry age-related macular degeneration (dry AMD).
The company presented the interim findings of the clinical study at this year’s International Society for Stem Cell Research (ISSCR) meeting. The meeting is held annually, but it was held virtually this year on June 27 due to the coronavirus. The presentation provided patient data for cohort 1 to 4.
Lineage also provided an update of its OPC1 program in which it has been developing an oligodendrocyte progenitor cell (OPC) therapy that targets acute spinal cord injury (SCI). The OPC1 program did not originally belong to Lineage, but it was the brainchild of another pharmaceutical called Asterias Biopharmaceuticals. The latter was acquired by Lineage in March 2019.
The acquisition allowed Linage to take over the OCP1 program and also Asterias’ Israeli-based Good Manufacturing Practice (cGMP) facility in which important process improvements took place. Lineage has also taken the necessary steps to boost its patent position so that it can protect OCP1 processes, composition, and product. The company also plans to hold a meeting with the FDA to talk about the OCP1 program’s further developments before the end of the year.
“We have worked diligently over the past year to transition all manufacturing activities for the OPC1 program to our in-house cGMP facility,” stated Lineage CEO, Brian M. Culley.
The CEO also noted that the work has allowed them to achieve higher efficacy levels, as well as improved quality control. Lineage expects these factors to contribute to a consistent supply of material that will facilitate the successful completion of OPC1’s late-stage clinical study. Once those important steps are completed, the company will shift its focus towards creating a “thaw-and-inject” formulation and the development of superior tools to facilitate the therapy’s delivery.
The company’s goal is to develop a smoother surgical procedure and ensure that patent enrollment in the next stage clinical study will be faster. Dr. Culley also added that the company’s approach for the OCP1 program will be similar to the strategy that is used for the OpRegen cell therapy program.
