Lineage Cell Therapeutics
Clinical-stage biotechnology company developing allogeneic cell therapies for degenerative disease, traumatic injury, and cancer.
Last updated August 24, 2026
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Overview
Lineage Cell Therapeutics is a clinical-stage biotechnology company focused on developing cell replacement and cell-based immunotherapy products for serious diseases with limited or inadequate treatment options. The company’s work is built around a proprietary cell-therapy platform and associated development and manufacturing capabilities that allow it to produce specialized, terminally differentiated human cells from pluripotent or progenitor starting materials. These cells are intended either to replace or support cells that have been lost or damaged through degeneration or traumatic injury, or to help stimulate an immune response against cancer. The company’s principal therapeutic strategy is allogeneic, or “off-the-shelf,” transplantation. Unlike individualized autologous approaches, allogeneic products are manufactured in advance from a common cell source and may be administered to multiple patients. Lineage has used this approach across programs in ophthalmology, neurology, spinal-cord injury, and oncology. Its lead program, OpRegen, is a retinal pigment epithelium cell replacement therapy being developed for geographic atrophy associated with advanced dry age-related macular degeneration. The program is being advanced through an exclusive worldwide collaboration with Genentech, a member of the Roche Group. Lineage also has OPC1, an oligodendrocyte progenitor cell therapy under clinical investigation for acute spinal cord injury. The program is intended to support remyelination and neurological recovery following traumatic injury and has received partial funding from the California Institute for Regenerative Medicine. VAC2 is an allogeneic dendritic-cell immunotherapy being studied in a Phase 1 trial for non-small cell lung cancer. Its clinical development has been funded and conducted by Cancer Research UK. The company’s earlier-stage pipeline includes ANP1, an auditory neuronal progenitor cell program for possible treatment of auditory neuropathy, and PNC1, a photoreceptor neural cell program for vision loss caused by photoreceptor dysfunction or damage. Lineage’s present identity emerged from a corporate transition away from the broader BioTime platform. The company changed its name from BioTime, Inc. to Lineage Cell Therapeutics after Brian Culley became chief executive officer in 2018 and after a series of transactions that included the distribution of AgeX Therapeutics, the acquisition of Asterias Biotherapeutics, and management changes. These actions concentrated the business on directed differentiation, manufacture, and transplantation of defined human cell types. In 2021, Lineage entered into an exclusive worldwide collaboration with Genentech for the development and commercialization of OpRegen. The agreement was reported as having a potential value of up to $670 million, subject to development, regulatory, and commercial conditions. In 2022, Lineage announced a new research and development facility in Carlsbad, California, together with an expansion of its good manufacturing practice facility in Israel. The investments were intended to increase U.S. research capacity, support current and future allogeneic transplant programs, and improve the scale and optimization of clinical manufacturing. Lineage remains a development-stage biotechnology company rather than a commercial pharmaceutical manufacturer. Its programs are experimental, and the cited candidates have not been described in the supplied reference material as broadly approved marketed therapies. The company’s positioning therefore rests on platform-based regenerative medicine, scalable cell manufacturing, and partnerships designed to advance selected candidates through clinical development.
History
Lineage Cell Therapeutics developed from BioTime, Inc., a biotechnology company whose business was reorganized around differentiated-cell therapies and regenerative medicine. The supplied reference material does not establish a definitive founding year or founder for the Lineage brand, so those fields are left unspecified. A major strategic transition occurred after Brian Culley was appointed chief executive officer in August 2018. During the period surrounding that leadership change, the company completed several corporate transactions, including the distribution of AgeX Therapeutics and the acquisition of Asterias Biotherapeutics. It subsequently changed its corporate name from BioTime to Lineage Cell Therapeutics. The reorganization narrowed the company’s mission toward the directed differentiation and transplantation of defined human cell types. Rather than pursuing a broad portfolio of unrelated biotechnology activities, Lineage emphasized a proprietary cell-based therapy platform, in-house development capabilities, and manufacturing processes designed to generate specialized cells from pluripotent and progenitor starting materials. The resulting cells could be used to replace cells lost through degenerative disease, support damaged tissue after traumatic injury, or function as immune-system components in cancer treatment. The company’s pipeline became organized around five allogeneic product candidates. OpRegen uses retinal pigment epithelial cells and was developed for geographic atrophy, an advanced form of dry age-related macular degeneration. OPC1 uses oligodendrocyte progenitor cells and entered clinical investigation for acute spinal cord injury. VAC2 uses antigen-presenting dendritic cells and was developed as an immunotherapy candidate for non-small cell lung cancer. ANP1 and PNC1 remained earlier-stage programs aimed respectively at auditory neuropathy and vision loss linked to photoreceptor dysfunction or damage. OpRegen became the company’s principal partnership asset. In December 2021, Lineage announced an exclusive worldwide collaboration with Genentech, part of the Roche Group, for the development and commercialization of the program. The reported potential value of the collaboration was $670 million, although the amount was dependent on future development and commercial events. Before and after the partnership, Lineage reported clinical observations from its Phase 1/2a study, including tolerability and preliminary signals involving visual function and retinal structure. These observations were investigational and did not establish regulatory approval. OPC1 continued in a Phase 1/2a multicenter study for acute spinal cord injuries, with partial support from the California Institute for Regenerative Medicine. VAC2 entered Phase 1 clinical development for non-small cell lung cancer through work funded and conducted by Cancer Research UK. ANP1 and PNC1 remained in process-development and preclinical work, reflecting Lineage’s strategy of maintaining a pipeline across several cell types and disease areas while advancing the most mature candidates through clinical testing. In October 2022, Lineage announced two infrastructure initiatives: a new research and development site in Carlsbad, California, and an expansion of its GMP manufacturing operation in Israel. The Carlsbad facility was intended to broaden U.S. research capacity and support current and future allogeneic cell-transplant programs. The Israeli expansion was designed to add infrastructure and improve development and optimization of larger-scale clinical manufacturing processes. Lineage’s history is therefore defined by corporate consolidation, a shift toward a focused cell-therapy identity, development of off-the-shelf differentiated-cell products, and selective collaboration with larger pharmaceutical and research organizations. Based on the supplied material, it remained a clinical-stage company with investigational programs rather than an established supplier of widely marketed cell therapies.
- 2022
OpRegen data presented at ARVO
[1]Lineage presented preliminary clinical data at the Association for Research in Vision and Ophthalmology annual meeting concerning tolerability and possible visual and retinal effects.
- 2022
Research and manufacturing infrastructure expansion
[1]Lineage announced a new Carlsbad research facility and an expansion of its GMP manufacturing facility in Israel.
- 2021
Exclusive worldwide OpRegen collaboration with Genentech
[1]Lineage announced a development and commercialization collaboration with Genentech for OpRegen, its retinal pigment epithelium cell therapy candidate.
- 2021
OpRegen interim clinical follow-up reported
[1]The company reported preliminary follow-up from its Phase 1/2a study, including observations on visual acuity, geographic atrophy, and safety.
- 2018
Brian Culley becomes chief executive officer
[1]Brian Culley was appointed CEO during a period of corporate restructuring and strategic refocusing.
- 2018
BioTime transitions to the Lineage Cell Therapeutics identity
[1]Following transactions including the distribution of AgeX Therapeutics and the acquisition of Asterias Biotherapeutics, BioTime changed its name to Lineage Cell Therapeutics and concentrated on differentiated-cell therapies.
Products and positioning
A clinical-stage regenerative-medicine and cell-therapy developer focused on scalable allogeneic products that replace, support, or immunologically activate human cells affected by degeneration, injury, or cancer.
Retinal cell replacement therapy
OpRegen
OpRegen is an allogeneic retinal pigment epithelium cell therapy candidate designed for geographic atrophy associated with advanced dry age-related macular degeneration. It is administered as a single-injection transplant approach and was studied in a multicenter Phase 1/2a trial. Reported preliminary findings included tolerability and possible improvements or stabilization-related signals in visual function and outer-retinal structure. The program is being developed under an exclusive worldwide collaboration with Genentech. It remains an investigational candidate in the supplied material.
Oligodendrocyte progenitor cell therapy
OPC1
OPC1 is an allogeneic oligodendrocyte progenitor cell therapy candidate for acute spinal cord injury. The program is intended to support damaged neurological tissue, including through potential remyelination-related mechanisms after traumatic injury. It has been evaluated in a multicenter Phase 1/2a clinical trial, with partial funding from the California Institute for Regenerative Medicine. The candidate is not described in the supplied material as an approved commercial therapy.
Dendritic-cell cancer immunotherapy
VAC2
VAC2 is an allogeneic antigen-presenting dendritic-cell therapy derived from Lineage’s VAC technology platform. It is intended to help generate an immune response against cancer and entered Phase 1 clinical development in non-small cell lung cancer. The clinical trial was funded and conducted by Cancer Research UK. The program also reflects the potential use of Lineage’s cell platform in immuno-oncology and infectious-disease applications.
Auditory neuronal progenitor cell therapy
ANP1
ANP1 is an auditory neuronal progenitor cell candidate being explored for the potential treatment of auditory neuropathy. The program was in process development and preclinical preparation in the supplied reference material, including work supporting planned preclinical testing. No commercial launch or regulatory approval is identified.
Photoreceptor neural cell therapy
PNC1
PNC1 is a photoreceptor neural cell therapy candidate intended for possible treatment of vision loss caused by photoreceptor dysfunction or damage. The program was undergoing process-development and preclinical activities in the supplied material. It represents a second ophthalmology application of Lineage’s differentiated-cell platform alongside OpRegen.
Brand decisions
2022
Expand research and GMP manufacturing infrastructureStrategyBackground
Lineage needed additional capacity to support current and future allogeneic cell-transplant programs and larger-scale clinical manufacturing.
Action taken
The company announced a new research and development facility in Carlsbad, California, and an expansion of its existing GMP manufacturing facility in Israel.
Aftermath
The initiatives were intended to broaden U.S. research capabilities and improve clinical manufacturing-process development and optimization.
2021
Partner OpRegen development and commercialization with GenentechM&ABackground
OpRegen was Lineage’s lead retinal cell-replacement candidate for geographic atrophy associated with dry age-related macular degeneration.
Action taken
Lineage granted Genentech exclusive worldwide collaboration rights for development and commercialization of OpRegen.
Aftermath
The partnership placed the lead ophthalmology program within a collaboration with a Roche Group company and provided a potential economic value reported at up to $670 million, subject to future conditions.
Potential collaboration value. Up to $670 million (Announced December 2021; contingent on development, regulatory, and commercial events)
2018
Refocus the company on directed differentiation and cell transplantationStrategyBackground
After new leadership and corporate transactions involving AgeX Therapeutics and Asterias Biotherapeutics, the company sought to concentrate its identity and resources on defined cell therapies.
Action taken
BioTime changed its name to Lineage Cell Therapeutics and organized its development strategy around proprietary cell manufacturing and transplantation of specialized human cells.
Aftermath
The reoriented company emphasized programs in retinal disease, neurological injury and degeneration, and cancer immunotherapy.
Recent events
- 2022
Lineage presents OpRegen data at the Association for Research in Vision and Ophthalmology meeting[1]
Other
Lineage presented Phase 1/2a data suggesting that OpRegen was tolerated in the reported study population and that preliminary changes in visual function and outer-retinal structure warranted continued investigation.
- 2022
Lineage announces Carlsbad research facility and Israel manufacturing expansion[1]
Other
Lineage announced a new research and development facility in Carlsbad, California, and an expansion of its existing GMP manufacturing facility in Israel. The projects were intended to strengthen U.S. research capabilities and support larger-scale clinical manufacturing.
- 2021
Lineage enters worldwide OpRegen collaboration with Genentech[2]
M&A · Other
Lineage announced an exclusive worldwide collaboration with Genentech, a Roche Group company, to develop and commercialize OpRegen for geographic atrophy associated with dry age-related macular degeneration. The arrangement was reported as potentially worth up to $670 million, subject to specified development, regulatory, and commercial conditions.
- 2021
Lineage reports OpRegen clinical findings in geographic atrophy[1]
Other
The company reported interim follow-up from a Phase 1/2a OpRegen study, including observations concerning visual acuity, geographic-atrophy areas, and tolerability in treated patients. The findings were preliminary and related to an investigational therapy.
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