Multiple Clinical Complete Responses Demonstrated Following Single Low Dose Administration of Bel-sar in Patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) in Ongoing Phase 1 Trial

Core Insights - Aura Biosciences announced positive early data from a Phase 1 clinical trial of bel-sar (AU-011) for non-muscle invasive bladder cancer (NMIBC), showing clinical complete responses in 4 out of 5 patients with low-grade disease [1][2][4] - The trial demonstrated a favorable safety profile, with less than 10% of patients experiencing Grade 1 drug-related adverse events and no serious adverse events reported [1][4] - The company plans to expand the ongoing Phase 1 trial and prepare for a Phase 2 trial to further evaluate the clinical activity and durability of response of bel-sar [2][3] Trial Design - The ongoing Phase 1 trial (NCT05483868) is a two-part, open-label study assessing the safety and feasibility of bel-sar as a monotherapy, with participants followed for safety monitoring over a 56-day period [3] - Part 1 of the trial is complete, involving 5 patients receiving a single bel-sar dose without light activation, while Part 2 is ongoing with 10 patients [3] - The study includes patients with a history of recurrent bladder cancer who have undergone multiple treatments prior to enrollment [3] Safety Data - As of the September 9, 2024 data cut-off, bel-sar was well-tolerated, with no Grade 2 or higher drug-related adverse events reported [4] - No significant differences were observed between the light-activated and non-light activated cohorts in terms of safety [4] Biological Activity - Clinical activity was detectable as soon as 7 days after a single low dose of bel-sar with light activation, evidenced by histopathological evaluations [4][5] - Among patients with low-grade disease, 4 out of 5 exhibited a clinical complete response, while 2 out of 3 patients with high-grade disease showed visual tumor shrinkage [5] - Immune activation was noted in all patients, indicating a potential bladder urothelial field effect beyond the target tumor [5] Upcoming Events - Aura will host a Virtual Urologic Oncology Investor Event featuring key opinion leaders to discuss the early Phase 1 data on October 17, 2024 [6]