Logo image
Development and biological characterization of a clinical gene transfer vector for the treatment of MAK-associated retinitis pigmentosa
Journal article   Open access   Peer reviewed

Development and biological characterization of a clinical gene transfer vector for the treatment of MAK-associated retinitis pigmentosa

Budd A Tucker, Erin R Burnight, Cathryn M Cranston, Mallory J Ulferts, Meagan A Luse, Trudi Westfall, C. Anthony Scott, Autumn Marsden, Katherine Gibson-Corley, Luke A Wiley, …
Gene therapy, Vol.29(5), pp.259-288
05/2022
DOI: 10.1038/s41434-021-00291-5
PMCID: PMC9159943
PMID: 34518651
url
https://doi.org/10.1038/s41434-021-00291-5View
Published (Version of record) Open Access

Abstract

AbstractBy combining next generation whole exome sequencing and induced pluripotent stem cell (iPSC) technology we found that an Alu repeat inserted in exon 9 of the MAK gene results in a loss of normal MAK transcript and development of human autosomal recessive retinitis pigmentosa (RP). Although a relatively rare cause of disease in the general population, the MAK variant is enriched in individuals of Jewish ancestry. In this population, 1 in 55 individuals are carriers and one third of all cases of recessive RP is caused by this gene. The purpose of this study was to determine if a viral gene augmentation strategy could be used to safely restore functional MAK protein as a step toward a treatment for early stage MAK-associated RP. Patient iPSC-derived photoreceptor precursor cells were generated and transduced with viral vectors containing the MAK transcript. One week after transduction, transcript and protein could be detected via rt-PCR and western blotting respectively. Using patient-derived fibroblast cells and mak knockdown zebra fish we demonstrate that over-expression of the retinal MAK transgene restored the cells ability to regulate primary cilia length. In addition, the visual defect in mak knockdown zebrafish was mitigated via treatment with the retinal MAK transgene. There was no evidence of local or systemic toxicity at 1-month or 3-months following subretinal delivery of clinical grade vector into wild type rats. The findings reported here will help pave the way for initiation of a phase 1 clinical trial for the treatment of patients with MAK-associated RP.

Details

Metrics

Logo image