相关临床试验
9
4 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中(未招募)
3
33.3%
已完成
2
22.2%
Enrolling By Invitation
1
11.1%
招募中
2
22.2%
终止
1
11.1%
暂无批准数据
- Bel-Sar (AU-011), a first-in-class virus-like drug conjugate, demonstrated complete responses in both injected and non-injected tumors in intermediate-risk and high-risk NMIBC patients. - The treatment induced rapid tumor necrosis, effector cell infiltration, and localized immune memory through a single, low-dose focal administration. - Bel-Sar converted immunologically "cold" tumors to "hot" tumors and reversed dysfunction in exhausted tumors while generating adaptive immune memory. - Only Grade 1 drug-related adverse events were observed, supporting further evaluation with higher doses and repeat cycles in ongoing phase 1b/2 studies.
• Aura Biosciences will present additional Phase 1 clinical data for bel-sar in non-muscle invasive bladder cancer at the upcoming European Association of Urology Congress in Madrid. • The presentation will showcase the latest findings on bel-sar, a novel therapeutic candidate being evaluated for patients with non-muscle invasive bladder cancer. • The company will also participate in the EAU Research Forum, providing an opportunity to engage with leading urological researchers and clinicians.
• Aura Biosciences reports progress in Phase 3 trial for choroidal melanoma with bel-sar, showing an 80% tumor control rate in Phase 2 among Phase 3-eligible patients. • The company is expanding bel-sar's development into bladder cancer, with a Phase 1 trial underway for non-muscle invasive and muscle invasive bladder cancer. • Financial results show increased operating expenses due to manufacturing and personnel growth, with funds expected to support operations into the second half of 2026. • Strategic initiatives include advancing bel-sar across multiple indications and expanding operational capabilities with a new office and laboratory lease in Boston.
• Aura Biosciences reports positive Phase 2 data for bel-sar in early-stage choroidal melanoma, demonstrating 80% tumor control and 90% visual acuity preservation. • Phase 1 trial of bel-sar in NMIBC shows clinical complete response in low-grade disease and immune activation, suggesting potential as a novel immune-ablative treatment. • The Phase 3 CoMpass trial for choroidal melanoma has received EMA authorization to begin enrolling patients in Europe, expanding the trial's global reach. • With a strong cash position, Aura Biosciences expects to fund operations into the second half of 2026, supporting ongoing clinical development programs.
• Belzupacap sarotalocan (bel-sar) demonstrates encouraging clinical activity and a favorable safety profile in patients with non-muscle-invasive bladder cancer (NMIBC) in an ongoing phase 1 trial. • In low-grade NMIBC patients treated with light-activated bel-sar, 4 of 5 achieved a complete clinical response, showing no tumor cells detected post-treatment. • The trial observed immune activation in both treated and untreated tumors, suggesting a bladder urothelial field effect with a single low dose of bel-sar. • Aura Biosciences plans to expand the phase 1 trial to optimize dosing and treatment regimens, with potential for a phase 2 registration-supporting trial.
- Bel-sar (AU-011) demonstrated an 80% tumor control rate in Phase 2 trial participants with early-stage choroidal melanoma. - The study showed a 90% visual acuity preservation rate among patients treated with bel-sar, offering a vision-sparing alternative to radiation. - The Phase 2 trial highlighted a favorable safety profile for bel-sar, with no serious adverse events reported during the study. - Aura Biosciences is advancing bel-sar into a Phase 3 trial, with potential to become a first-line treatment for choroidal melanoma.