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Aura Biosciences, developers of virus-like drug conjugate bel-sar (belzupacap sarotalocan, previously named AU-011) therapy for early-stage choroidal melanoma, announced phase 2 safety and efficacy data including 89-100% tumour control and 88% visual acuity preservation.
The trial included 20 adult patients and 9-10 months of follow up after suprachoroidal administration of infrared-light-activated bel-sar. Dr Ivana Kim, director of the Ocular Melanoma Center, Massachusetts Eye and Ear, said the safety profile to date has been favourable, with only one patient losing visual acuity and no treatment-related significant adverse events. “This is encouraging, given that the majority of these patients had tumours close to the fovea or optic disk and would have likely experienced severe and irreversible vision loss with the current standard of care with radiotherapy,” she said.
“Collectively, we believe these interim data provide strong confidence to support the launch of a global phase 3 trial, which is on track to begin enrolment this year,” said Dr Cadmus Rich, Aura Biosciences’ chief medical officer. Full results were presented at the US Macula Society’s annual meeting in February this year.