In March 2026, Lineage Cell Therapeutics launched a new cell therapy programme for the treatment of corneal endothelial disease. Diana Turner caught up with Brian Culley, CEO of Lineage Cell Therapeutics, to find out more. 

DT: How do you hope your in-house AlloSCOPE platform can overcome the problems and  practical hurdles associated with other cell therapies?

BC: Pluripotent cells, widely recognised for their ability to become any human cell type, have potential applications across many areas of medicine with large unmet patient needs, including certain age-related degenerative diseases, degenerative conditions, or traumatic injuries. However, a significant challenge facing the cell therapy field is the ability to create a stable cell product with the necessary purity, control, reproducibility, potency and other critical manufacturing attributes, while also achieving the scale and cost required to adequately and profitably supply the addressable patient population. 

Our proprietary AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) manufacturing platform is designed to address these hurdles. It enables a proprietary differentiation and production modality through which we can manufacture allogeneic, cell-based products derived from a single initial cell line, for the purpose of enabling consistent, cost-effective, and scalable cell-based production.  

Functional cells developed from these lineages, and relevant to the underlying condition, are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, ageing, or traumatic injury; and restore or enhance the patient’s functional activity in that target tissue. 

To further address practical barriers to adoption, in some instances we incorporate a proprietary “thaw-and-inject” formulation, allowing for rapid dosing and “immediate use” of our cells. This approach helps reduce the lengthy and complex dose preparation steps often associated with certain cell therapy programmes.  

DT: What success have you had with the platform so far?  

BC: We have successfully completed a GMP production run for two separate product candidates, each produced from a customised, two-tiered cGMP cell banking system, highlighting the application of the Lineage AlloSCOPE platform across multiple programmes and using different cell lines. This two-tiered production process has the capacity to enable the scalable, consistent, and cost-effective production of millions of doses of an allogeneic cell-based product derived from a single starting cell line. 

Our lead programme OpRegen is a suspension of allogeneic retinal pigment epithelial (RPE) cells currently in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Subretinal delivery of OpRegen has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. It is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase IIa clinical study, GAlette, in patients with GA secondary to AMD.  

Positive clinical results from Lineage’s Phase I/IIa clinical study of OpRegen, presented by our partners most recently at the 2026 Retinal Innovation Summit, have continued to demonstrate improved retinal anatomy, halting of atrophic progression, and improved vision in patients with dry AMD, following a single administration of OpRegen, three-years post treatment. We believe this is a notable finding given that dry AMD is a condition which is progressive and does not self-resolve. 

Our second clinical-stage programme, OPC1, is an allogeneic oligodendrocyte progenitor cell therapy designed to improve recovery following a spinal cord injury. OPC1 has been administered in two Phase I/IIa safety trials in subacute patients, and the long-term safety and efficacy data collected to date are promising and support its continued clinical development. 

DT: Why have you chosen to target corneal endothelial disease with your next programme? What are some of the challenges in treating this disease? 

BC: Corneal endothelial disease is a progressive, often hereditary condition where cells on the inner layer of the cornea die, leading to corneal swelling and vision loss. Fuchs endothelial corneal dystrophy (FECD) is the most common primary corneal endothelial dystrophy and is the leading indication for corneal transplantation worldwide. However, there is only one donor cornea available for every 70 diseased eyes globally, highlighting a significant unmet medical need. The supply of corneal endothelial cells (CEnCs) from cadaveric donor tissue is further constrained by the limited availability of organ donors, inconsistent cell yields and variability in cell quality, underscoring the need for scalable, reliable alternative therapies. We believe there is an opportunity to address the unmet need for reliable, consistent, scalable and cryopreserved supply of CEnCs. 

Our COR1 programme is an internally developed and wholly-owned preclinical cell transplant aimed at providing a consistent and affordable supply of corneal endothelial cells. We believe the COR1 programme can benefit from our ophthalmology and manufacturing expertise and highlights our approach by focusing on what we do best: large scale and high-quality cell manufacturing. 

Leveraging the capabilities of our AlloSCOPE platform and a proprietary pluripotent cell line, we have manufactured “off the shelf” CEnCs with the appropriate identity, morphological, and functional characteristics to develop a more consistent and cost-effective product that could potentially address the global shortage of donor cells. 

FECD represents one of the largest underserved populations in ophthalmology, affecting approximately 7.33% of adults over 30 years of age globally, with the patient population projected to increase from approximately 300 million in 2020 to 415 million by 2050.  

DT: What is COR1’s mechanism of action? What evidence is there to support it? 

BC: COR1 is designed as an allogeneic CEnC cell transplant therapy, intended to restore the cornea’s fluid-pumping function through targeted cell replacement. Following intracameral injection into the anterior chamber of the eye, the transplanted cells are expected to adhere to the posterior corneal surface (Descemet’s membrane), form a functional monolayer, and restore endothelial pump activity. This process is intended to reduce corneal oedema and improve transparency and vision. The therapeutic rationale is supported by the well-established role of corneal endothelial cells in maintaining stromal dehydration, as well as prior approval and clinical testing in Japan, where cultured endothelial cell injections (in combination with ROCK inhibition) have demonstrated feasibility and improved corneal clarity and visual acuity in patients with bullous keratopathy. 

DT: What advantages could this treatment offer over corneal transplant?  

BC: COR1 may offer several potential advantages over traditional corneal transplantation by providing an allogeneic, “off-the-shelf” source of corneal endothelial cells that could address the significant global shortage of donor tissue, where only approximately one cornea is available for every 70 patients in need. Unlike transplant procedures such as DMEK or DSAEK, which require invasive surgery and reliance on variable-quality cadaveric tissue, COR1 is designed to be administered via intracameral injection, representing a potentially less invasive approach. In addition, the use of Lineage’s AlloSCOPE platform may enable scalable, consistent manufacturing of corneal endothelial cells, which could improve product uniformity and expand access to treatment. 

DT: What are next steps for the development of COR1?  

BC: Following the recent launch of COR1, we are now looking to advance the programme through preclinical development while continuing to leverage the AlloSCOPE manufacturing platform to support scalable production and reduce manufacturing costs. As noted on our Q1 2026 earnings call, we would plan to advance this programme first into translational models and thereafter into initial human testing. 

DT: Your recently sold your OpRegen programme for dry AMD to Genentech for $670m and have other high profile research partnerships. Are you hoping for similar interest from big pharma in COR1?  

BC: Our license agreement with Genentech included a $50 million up-front payment and brought valuable additional insights into the programme, so we are always interested in beneficial partnership opportunities similar to that one. In the normal course of business, we maintain a constant flow of such discussions with potential partners, both confidentially and not, mostly through our business development team. But the bar for entering into a partnership is and should be very high. We believe that we are developing potentially transformative therapies and choosing the right partner at the right time, if ever, is an important activity.     

DT: What do you think is the potential for cell therapy in eye diseases? Could this be a standard treatment for eye conditions related to degeneration or ageing in the future?   

BC: Cell therapy holds significant potential in eye diseases, as replacing cells that have become dysfunctional or destroyed may fundamentally reshape treatment and recovery paradigms. While the application of cell therapy outside of oncology remains in the early stages, fields such as ophthalmology represent promising new frontiers.  

Biography

Brian Culley joined Lineage as Chief Executive Officer in September 2018. Prior to joining Lineage, Culley served as interim Chief Executive Officer at Artemis Therapeutics, and in various senior roles at Mast Therapeutics.  

From DDW Volume 27 – Issue 3, Summer 2026 – Read the digital issue here