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June 19,Jinweike Biotechnology Announces Its Self-Developed Treatment for NeovascularizationAge-related Macular Degeneration(nAMD) Gene Therapy Innovative Drug "JWK001 Injection"IITClinical Study Low-Dose GroupFirst SubjectCompleted 52-week follow-up observationAccording to the follow-up examination data, the efficacy of the JWK001 drug is long-lasting and its safety is good.
JWK001The injection is the first AAV gene therapy new drug to use a "two-plasmid packaging system".By delivering an AAV vector carrying a completely new self-designed anti-VEGF protein expression cassette, the anti-VEGF protein is continuously and efficiently expressed in retinal cells.The first subject of the IIT clinical study was dosed on June 7, 2023, and the IND was approved in February 2024. The Phase I/II clinical study is currently ongoing.
nAMDIt is an irreversible ophthalmic disease that severely affects vision and can even lead to blindness. The traditional treatment for nAMD involves long-term and frequent injections of anti-vascular endothelial growth factor.JWK001 can avoid the risks associated with traditional nAMD treatments, achieving efficacy in a single treatment.After 52 weeks of dosing,The best corrected visual acuity (BCVA) of the first subject in the low-dose group increased from 51 to 62 letters, improving by 11 letters (as measured by the EDTRS corrected visual acuity chart).Before the first subject in the low-dose group received JWK001, they had undergone a total of 9 anti-VEGF injections, averaging one injection every 1.17 months. After receiving JWK001, the patient remained stable at 52 weeks.No need for additional anti-VEGF treatment., demonstrating good efficacy.
Figure: 52-week BCVA Data of the First Subject
According to the assessment by optical coherence tomography, the central retinal thickness (Central Retinal Thickness, CRT) of the first subject in the low-dose group remained stable 52 weeks after dosing.
Figure: 52-week CRT data of the first subject
In terms of safety, the safety data of JWK001 is basically consistent with previous studies. None of the subjects enrolled in the IIT experienced AE or SAE related to the trial drug. No clinically confirmed immune response was observed, and there were no drug-related ocular inflammatory diseases (such as vasculitis, retinitis, choroiditis, vascular occlusion, or endophthalmitis), demonstrating the overall good safety and tolerability of the drug.Chengdu Jinweike Biotechnology Co., Ltd. is a biotechnology company dedicated to the development of AAV gene therapy new drugs for ophthalmic diseases, neuromuscular diseases, and genetic metabolic diseases. Currently, several AAV gene therapy products in its pipeline have entered the IIT clinical research stage.
Source of the article:Jinweike Biotechnology
