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Subject: Product/Service

LUXA BIO Announces First Participant Dosed in Phase 1/2a Clinical Trial of Adult RPESC-RPE-4W for Dry Age-related Macular Degeneration

Luxa Biotechnology (LuxaBio), a joint venture between Y2 Solution Co. Ltd, Seoul, South Korea and the Neural Stem Cell Institute (NSCI), Rensselaer, New York, today announced transplantation of the cell product RPESC-RPE-4W into the first participant with dry age-related macular degeneration (dry AMD) in its Phase 1/2a clinical trial (NCT04627428) being conducted at the University of Michigan Kellogg Eye Center.

RPESC-RPE-4W is a cell product derived from the retinal pigment epithelium stem cell (RPESC) that is present in the adult human retina. This adult stem cell produces retinal pigmented epithelium (RPE) cell progeny (RPESC-RPE). The cell product being used in the clinical trial is a progenitor stage RPESC-RPE cell obtained after 4 weeks of differentiation (RPESC-RPE-4W). The RPESC-RPE-4W progenitor stage cell has shown increased engraftment and vision rescue compared to more mature RPE cell products.

"AMD with a loss of RPE cells results in loss of central visual acuity, leading to legal blindness in millions of patients," said Jeffrey Stern, MD, PhD, founder of NSCI. "Our RPESC-RPE-4W cell transplantation trial aims to address the great unmet medical need presented by dry AMD, for which there is no approved therapy."

Laboratory studies of RPESC-derived RPE cells demonstrated they could perform the critical repertoire of cell functions carried out by normal RPE cells, including trophic factor release and phagocytosis. Sub-retinal implantation in an animal model of retinal degeneration showed that RPESC-RPE-4W cells engraft into the RPE layer. Transplanted RPESC-RPE-4W provided durable preservation of RPE cell functions and supported overlying photoreceptor cells, resulting in vision rescue that was maintained for the life of the animal. RPESC-RPE-4W has significant safety attributes in animal models, including lack of tumor formation.

Adult RPESC are obtained from eyes donated to eye banks. A single donor produces sufficient RPESC-RPE-4W cells for several hundred doses. The RPESC-RPE-4W cell product is being manufactured at the Cedars Sinai Biomanufacturing Center in Los Angeles and the formulated doses are shipped to the clinical site for implantation.

Dr. Rajesh Rao, the trial Principal Investigator at Kellogg Eye Center, transplanted 50,000 RPESC-RPE-4W cells under the macula of a study participant with advanced dry AMD. The Phase 1/2a study will enroll up to 18 participants to assess the safety, tolerability, feasibility, and preliminary efficacy of subretinal RPESC-RPE-4W in a dose escalation, open-label study. The trial is co-sponsored by the National Eye Institute of the National Institutes of Health under a Regenerative Medicine Innovation Project cooperative agreement.

About Luxa Biotechnology

Luxa Biotechnology (LuxaBio) is a clinical-stage biotechnology company developing a novel adult RPE stem cell therapy for dry AMD. The proprietary adult RPESC-RPE-4W stem cell product was developed at and licensed from the NSCI. LuxaBio is a partnership between the NSCI research institute and Y2 Solutions, a Korean company advancing RPESC in a clinical trial to test safety and efficacy as a potential therapy for dry AMD. LuxaBio maintains a robust research program at NSCI to develop the RPESC as an effective, commercially viable cell product. The Phase 1/2a Clinical Trial of RPESC-RPE-4W for the Treatment of Dry Age-related Macular Degeneration includes the Cedars Sinai Biomanufacturing Center, The Emmes Company, the University of Michigan Kellogg Eye Center and the National Eye Institute. For more information, please contact [email protected].

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