Movers and SHAKERS
Lineage Cell Therapeutics (LCTX)
OPC1 Investor and Analyst Day Overview
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.
Ahu Demir, Ph. D., Biotechnology Research Analyst, Noble Capital Markets, Inc.
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Where is the OPC1 program now? Lineage held an Investor and Analyst Day highlighting the OPC1 program, the oligodendrocyte progenitor cell therapy for acute spinal cord injuries. The program was granted Orphan Drug and Regenerative medicine advanced therapy (RMAT) Designations, and also over 14 million support from the California Institute for Regenerative Medicine (CIRM). The Phase 1/2 (SCiStar) clinical trial partially sponsored by CIRM has completed enrollment with 25 patients. Ninety-six percent (96%) of the patients showed motor recovery in at least 1 motor level gain on at least 1 side. Furthermore, 5/6 cohort 2 patients achieved significant motor improvements. The company made significant progress in manufacturing and quality of OPC1 in the last year, and also entered into an agreement with Neurgain to utilize the New Parenchymal Delivery Injection (PDI) System for the administration of OPC1.
Where is the program going? The next steps for this program include assessing and improving adaptation and compatibility of PDI for OPC1 administration, gathering data, and conducting a Food and Drug Administration (FDA) meeting to discuss the comparability plan. The company will identify details to further assess OPC1 for the treatment of spinal cord injury in a randomized, controlled clinical ...
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.