KH658 / Chengdu Kanghong Pharma - LARVOL DELTA

Suprachoroidal Delivery of Gene Therapy for Neovascular Age-Related Macular Degeneration (nAMD): Phase I Preliminary Safety and Efficacy of KH658 (ASGCT 2026) - "This study demonstrates that therapeutic anti-VEGF levels can be achieved via SCS delivery without the intraocular inflammatory profile associated with intravitreal vectors. These data support a single SCS injection of KH658 for nAMD is feasible and warrant further exploration."

Clinical • Gene therapy • P1 data • Age-related Macular Degeneration • Conjunctivitis • Gene Therapies • Hematological Disorders • Inflammation • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Suprachoroidal Delivery of KH658 Bypasses Pre-Existing Immunity: Anti-VEGF Efficacy Maintained in Seropositive Rhesus Macaques in a Laser-Induced CNV Model (ASGCT 2026) - "*: P≤0.05 (Positive control group: n=8; KH658 5×1011 vg/eye group: n=8, KH658 1.0×1012 vg/eye group: n=8, KH658 2×1012 vg/eye group: n=7, KH658 buffer control group: n=8). ?: The value was 0.00±0.000 in this group, which could not be shown in the bar chart."

Clinical • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Phase I Study of Suprachoroidal Delivery of KH658 Gene Therapy for Neovascular Age-Related Macular Degeneration (nAMD) (ARVO 2026) - "Conclusions A single suprachoroidal injection of KH658 was well tolerated at dose levels of 5.0×1011 to 4.0×1012 vg/eye. A substantial reduction in the annualized injection frequency at all dose levels was observed compared to the pre-study period, while mean BCVA and CRT remained stable."

Gene therapy • P1 data • Age-related Macular Degeneration • Conjunctivitis • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Phase I, Open-label, Multicenter, Dose-Escalating Study to Evaluate the Safety and Tolerability of KH658 Gene Therapy in Participants With Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: Chengdu Origen Biotechnology Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Trial initiation date • Trial primary completion date • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Biodistribution in ocular tissues after suprachoroidal injection of KH658 in cynomolgus monkeys (ASGCT 2025) - "The transgene and transgene product of KH658 were predominantly distributed within the retina, choroid, and sclera, which is consistent with the characteristics of suprachoroidal injection. The high concentration of anti-VEGF transgene products within the retina suggests that suprachoroidal administration of KH658 may represent a treatment option for nAMD. Disease Focus of Abstract:Ophthalmic Diseases"

Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Chengdu Origen and Vanotech Announce First Patient Dosed in VAN-2401 Phase 1 Trial of Gene Therapy for Wet Age-Related Macular Degeneration (GlobeNewswire) - "Chengdu Origen Biotechnology Co., Ltd. ('Chengdu Origen') and Vanotech Ltd. ('Vanotech') announced today the first patient dosed in the VAN-2401 multi-center Phase 1 clinical trial evaluating treatment with KH658 for patients with wet Age-related Macular Degeneration (wet AMD). This multi-center, open-label, dose-escalation clinical trial in the U.S. will assess the safety, tolerability and efficacy of KH658 as a single suprachoroidal space administration of gene therapy for patients with previously treated wet AMD."

Trial status • Wet Age-related Macular Degeneration

Safety profile of a suprachoroidal space injection of KH658 in rhesus monkeys (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Phase I, Open-label, Multicenter, Dose-Escalating Study to Evaluate the Safety and Tolerability of KH658 Gene Therapy in Participants with Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P1 | N=9 | Not yet recruiting | Sponsor: Chengdu Origen Biotechnology Co., Ltd.

New P1 trial • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD) (clinicaltrials.gov) - P1/2 | N=44 | Recruiting | Sponsor: Chengdu Origen Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Gene therapy • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD) (clinicaltrials.gov) - P1/2 | N=44 | Not yet recruiting | Sponsor: Chengdu Origen Biotechnology Co., Ltd.

Gene therapy • New P1/2 trial • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration