Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX) provided an update on its COR1 program, an allogeneic corneal endothelial cell (CEnC) transplant therapy in preclinical development for corneal endothelial disease.

The company said it has manufactured corneal endothelial cells using its AlloSCOPE platform that meet internal thresholds for potency, identity, and scale. Lineage said it will advance COR1 into in-vivo animal testing, with initial data expected later this year.

COR1 uses a "thaw-and-inject" formulation designed to allow cryopreserved storage and immediate use. The program employs the company's AlloSCOPE 5D manufacturing process, which uses bioreactor-based expansion and differentiation. Lineage said its two-tiered GMP cell banking system could potentially generate millions of doses of the final product.

The program is aimed at addressing limitations of donor-derived cadaveric CEnCs, which include limited supply, donor variability, and short shelf life. Cadaver-derived CEnCs are currently approved in Japan for corneal endothelial disease treatment.

According to the press release, globally there is one donor cornea available for every 70 diseased eyes, with over 13 million people waiting for a corneal transplant. Fuchs endothelial corneal dystrophy, the leading indication for corneal transplantation, affects approximately 7.33% of adults over 30 years of age globally.

"We have successfully manufactured corneal endothelial cells that meet our initial thresholds for potency, identity, and scale," said Brian M. Culley, Lineage CEO, adding that the company believes its AlloSCOPE platform is positioned to deliver a consistent allogeneic source of CEnCs.

COR1 is one of several programs in Lineage's pipeline, which also includes OpRegen, a retinal cell therapy in Phase 2a development under a collaboration with Roche and Genentech, and OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for spinal cord injuries.