Chengdu Origen Biotechnology and Vanotech have initiated the first subject dosing in the open-label Phase I trial, VAN-2401 of the gene therapy KH658, as a single suprachoroidal space administration for treating individuals with neovascular wet age-related macular degeneration (wet AMD).
The multi-centre dose-escalation trial in the US will evaluate the therapy’s tolerability, safety, and efficacy for this patient population.
The trial is expected to include around nine subjects who have undergone treatment for wet AMD before and have shown a response to anti-vascular endothelial growth factor (VEGF) treatments.
Vanotech chief medical officer Avner Ingerman said: “Dosing our first patient in the VAN-2401 Phase I trial is an important milestone in the advancement of KH658 by exploring the potential of single suprachoroidal space administration of gene therapy as treatment for wet AMD.
“KH658 is designed to deliver anti-VEGF continuously to the retina, with the potential to provide sustained levels that can control the disease.”
Besides being the sponsor representative, Vanotech is responsible for the clinical development programme for the therapy in the US.
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By GlobalDataKH658 is stated to be a recombinant adeno-associated virus vector encoding a human VEGF receptor fusion protein.
Preclinical studies have shown that the therapy’s suprachoroidal space administration led to prolonged retention of the transgene product in the retina and prevented the progression of the disease.
Chengdu Origen develops gene therapies for individuals with chronic and genetic conditions and claims to be equipped with the infrastructure and capabilities required for the production of viral vectors.
In addition to VAN-2401, Vanotech is conducting another Phase I trial, VAN-2201, assessing the efficacy, tolerability, and safety of a one-time administration of KH631 in individuals with wet AMD.
In November 2023, the companies dosed the first subject in the VAN-2201 trial. Wet AMD is stated to be marked by vision loss caused by abnormal blood vessel growth in and under the retina.
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