Lineage Cell Therapeutics Inc. (NYSEAMERICAN: LCTX) Gains After FDA Gives Feedback On OPC1 IND

Lineage Cell Therapeutics Inc. (NYSEAMERICAN: LCTX) gained 2.16% after releasing an update in OPC1’s clinical development. OPC1 is the company’s experimental allogeneic oligodendrocyte progenitor cell (OPC) transplant therapy for spinal cord injury treatment. 

Lineage receives FDA feedback on OPC1 IND

Last week the company received feedback from the FDA under the US FDA’s Regenerative Medicine Advanced Therapy program. As a result, Lineage is planning to submit an amendment to its IND for OPC1 to support the first phase clinical study evaluating the performance and safety of Neurgain technologies Inc.’s Parenchymal Spinal Delivery System to deliver OPC1 cells to the spinal cord. 

The company and Neurgain signed an exclusive option and license agreement in February to study Neurgain’s innovative PSD system in preclinical and clinical settings. The FDA is scheduled to receive the IND modification in Q4 2021. Equally, data from the Phase 1 clinical study will be used to qualify the Neurgain PSD system for use in a later-stage clinical trial, which is expected to start in 2022 once the Phase 1 study is completed.

Lineage increasing purity and production of OPC1 cells 

Lineage’s CEO, Brian M. Culley, said, “It is a privilege to report that our novel OPC1 program will be returning to clinical testing earlier than anticipated. There currently are few opportunities for SCI patients to participate in clinical trials, so we are excited to re-engage with these patients and their advocacy community as part of our efforts to improve outcomes for individuals with this debilitating condition, for which there are no FDA-approved treatments.”

Culley added that the company had enhanced the production scale and purity of OPC1 cells used in previous clinical studies in the past one and half years. He said that the enhanced production process had been moved to the company’s in-house cGMP suite.