OpRegen Status
Genentech is currently running the Phase 2a trial. Under the current agreement from January 2022, LCTX received $50M up front and is eligible to recieve $620 million in milestone payments. Along with this, LCTX is eligible to recieve “double-digit percentage royalties”. They also entered into a second agreement with Genentech in May 2024 that would train LCTX how to generate OpRegen. In September, the FDA gave Regenerative Medicine Advanced Therapy (“RMAT”) designation.
OPC1 Status
OPC1 is an “allogeneic oligodendrocyte progenitor” cell therapy designed to help spinal cord injury patients recover. Currently, this program is funded by a $14.3 million grant from the California Institute for Regenerative Medicine (“CIRM”). LCTX plans on applying for additional funding in Spring of 2025. Starting in February 2025, a new study was started to test a new delivery mechanism for OPC1. This new study will include both new injury patients as well as chronic (1-5 year post injury) patients. This will be the first time studying chronic patients so it will be interesting to see if that group of patients sees any effects from OPC1. Neurgain Technologies, Inc owns the delivery system that is being tested for OPC1. In previous studies, the patients ventilator had to be stopped to perform the injection. With this new delivery system, surgeons are able to deliver OPC1 without stopping the patient’s ventliator.
Other pipeline drugs
- ReSonance (ANP1) - An allogeneic auditory neuron progenitor cell transplant in preclinical development for sensorineural hearing loss
- PNC1 - Allogeneic photoreceptor in preclinical development to restore vision loss due to photoreceptor dysfunction or damage
- RND1 - Cell transplant program for an undisclosed indication through a collaboration with Factor Biosciences Limited.
- Previous partner was Eterna Therapeutics. Assigned agreement to Factor in September 2024
- unnamed - A proprietary hypoimmune cell line - May have utility in central nervous system indications