Aura Biosciences begins dosing in belzupacap sarotalocan phase 1 trial in NMIBC
Aura Biosciences said that it has dosed the first patient in a phase 1 clinical trial of its first virus-like drug conjugate (VDC) — belzupacap sarotalocan for the treatment of non-muscle invasive bladder cancer (NMIBC).
According to the NASDAQ-listed clinical-stage biotech company, the early-stage multi-center, open label study is likely to take in nearly 23 adults having the type of bladder cancer.
The phase 1 clinical trial of belzupacap sarotalocan will evaluate the safety and tolerability of the virus-like drug conjugate as a single agent.
The primary endpoint of the early-stage non-muscle invasive bladder cancer clinical trial is the incidence and severity of treatment-associated adverse events and serious adverse events and the occurrence of dose-limiting toxicities.
Aura Biosciences expects to release initial phase 1 data of the belzupacap sarotalocan clinical trial in 2023. In June 2022, the virus-like drug conjugate was issued fast track designation from the US Food and Drug Administration (FDA).
Dr. Cadmus Rich — Aura Biosciences Chief Medical Officer and Head of research and development said: “Dosing of the first patient in this Phase 1 study is an exciting key milestone both for Aura and for the field of urologic oncology, as approximately 70% of patients with bladder cancer globally are diagnosed early with NMIBC.
“There have been no major advances in the early treatment of NMIBC in over two decades. We look forward to presenting initial Phase 1 data in 2023 and advancing the development of a potential new therapeutic option for patients with a high unmet medical need.”