Clinical trial of KH631 evaluates single administration gene-therapy treatment for wet AMD
CHENGDU, China and ROCKAWAY, NJ, USA I November 20, 2023 I Chengdu Origen Biotechnology Co., Ltd. (“Chengdu Origen”) and Vanotech Ltd. (“Vanotech”) announced today the first patient dosed in the VAN-2201 multi-center Phase 1 clinical trial evaluating treatment with KH631 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 KH631 as a single administration gene therapy for patients with previously treated wet AMD.
KH631 is a recombinant adeno-associated virus vector that encodes a human VEGF receptor fusion protein. In preclinical studies of wet AMD disease models, administration of KH631 resulted in retention of the transgene product in the retina for prolonged periods and prevented the disease progression. These findings may indicate the potential of KH631 to offer a single administration treatment for wet AMD patients.
“Dosing our first patient in the VAN-2201 Phase 1 trial is an important milestone in the advancement of KH631 by exploring the potential of single administration gene therapy as treatment for wet AMD. KH631 is designed to deliver anti-VEGF continuously to the retina, with the potential to provide sustained levels that can control the disease,” said Avner Ingerman, M.D., Chief Medical Officer of Vanotech.
“I am excited to participate as a principal investigator in this important study. Dosing the first patient is an important milestone in the development of the single-administration gene therapy approach, which may hold promise to our patients in need of frequent treatment for their retinal diseases,” said Jeffrey S. Heier, M.D., a principal investigator in the VAN-2201 Phase 1 trial, director of the Vitreoretinal Service and Director of Retina Research at Ophthalmic Consultants of Boston
About the VAN-2201 Phase 1 Clinical Trial
VAN-2201 is a Phase 1, multi-center, open-label, dose‑escalation study in subjects with wet AMD to evaluate safety, tolerability and efficacy of a single administration of KH631. The study is expected to include approximately twenty-five previously treated wet AMD subjects that are responsive to anti-vascular endothelial growth factor (anti-VEGF) therapy. For more information, please visit https://www.clinicaltrials.gov/study/NCT05657301.
About Wet AMD
Wet AMD is the rarer form of AMD, characterized by loss of vision due to abnormal blood vessel formation in and under the retina. These blood vessels tend to leak, and the fluid interferes with the normal retinal structure and function, leading to vision loss. Wet AMD is a leading cause of irreversible vision loss or blindness in the United States and Europe, especially if left untreated. It is estimated that ~1.5 million people living with wet AMD in the United States.
Anti-VEGF therapies have become the standard of care for wet AMD. Anti-VEGF treatments reduce leakage and fluid accumulation, thereby restoring normal retinal architecture and function, in many patients. Anti-VEGF agents require frequent, repeat injections to maintain efficacy and control the disease.
About Chengdu Origen and Vanotech
Chengdu Origen is a clinical-stage gene therapy company focused on developing gene therapy for unmet medical needs and providing meaningful clinical benefits for patients suffering from genetic and chronic diseases and has comprehensive viral vector manufacturing capabilities and infrastructure.
Vanotech is operating as the sponsor-representative, and is responsible for the clinical development program of KH631 in the united States.
SOURCE: Vanotech
Post Views: 322
Clinical trial of KH631 evaluates single administration gene-therapy treatment for wet AMD
CHENGDU, China and ROCKAWAY, NJ, USA I November 20, 2023 I Chengdu Origen Biotechnology Co., Ltd. (“Chengdu Origen”) and Vanotech Ltd. (“Vanotech”) announced today the first patient dosed in the VAN-2201 multi-center Phase 1 clinical trial evaluating treatment with KH631 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 KH631 as a single administration gene therapy for patients with previously treated wet AMD.
KH631 is a recombinant adeno-associated virus vector that encodes a human VEGF receptor fusion protein. In preclinical studies of wet AMD disease models, administration of KH631 resulted in retention of the transgene product in the retina for prolonged periods and prevented the disease progression. These findings may indicate the potential of KH631 to offer a single administration treatment for wet AMD patients.
“Dosing our first patient in the VAN-2201 Phase 1 trial is an important milestone in the advancement of KH631 by exploring the potential of single administration gene therapy as treatment for wet AMD. KH631 is designed to deliver anti-VEGF continuously to the retina, with the potential to provide sustained levels that can control the disease,” said Avner Ingerman, M.D., Chief Medical Officer of Vanotech.
“I am excited to participate as a principal investigator in this important study. Dosing the first patient is an important milestone in the development of the single-administration gene therapy approach, which may hold promise to our patients in need of frequent treatment for their retinal diseases,” said Jeffrey S. Heier, M.D., a principal investigator in the VAN-2201 Phase 1 trial, director of the Vitreoretinal Service and Director of Retina Research at Ophthalmic Consultants of Boston
About the VAN-2201 Phase 1 Clinical Trial
VAN-2201 is a Phase 1, multi-center, open-label, dose‑escalation study in subjects with wet AMD to evaluate safety, tolerability and efficacy of a single administration of KH631. The study is expected to include approximately twenty-five previously treated wet AMD subjects that are responsive to anti-vascular endothelial growth factor (anti-VEGF) therapy. For more information, please visit https://www.clinicaltrials.gov/study/NCT05657301.
About Wet AMD
Wet AMD is the rarer form of AMD, characterized by loss of vision due to abnormal blood vessel formation in and under the retina. These blood vessels tend to leak, and the fluid interferes with the normal retinal structure and function, leading to vision loss. Wet AMD is a leading cause of irreversible vision loss or blindness in the United States and Europe, especially if left untreated. It is estimated that ~1.5 million people living with wet AMD in the United States.
Anti-VEGF therapies have become the standard of care for wet AMD. Anti-VEGF treatments reduce leakage and fluid accumulation, thereby restoring normal retinal architecture and function, in many patients. Anti-VEGF agents require frequent, repeat injections to maintain efficacy and control the disease.
About Chengdu Origen and Vanotech
Chengdu Origen is a clinical-stage gene therapy company focused on developing gene therapy for unmet medical needs and providing meaningful clinical benefits for patients suffering from genetic and chronic diseases and has comprehensive viral vector manufacturing capabilities and infrastructure.
Vanotech is operating as the sponsor-representative, and is responsible for the clinical development program of KH631 in the united States.
SOURCE: Vanotech
Post Views: 322
