Aura Biosciences, Inc.
Aura Biosciences, Inc. is a clinical-stage oncology company, which engages in developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The firm's product candidate belzupacap sarotalocan (AU-011) is in Phase 2 development for the first line treatment of choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. The was founded by Elisabet de los Pinos in 2007 and is headquartered in Boston, MA.
Clinical Trials
9
4 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2007
Active, not recruiting
3
33.3%
Completed
2
22.2%
Enrolling By Invitation
1
11.1%
Recruiting
2
22.2%
Terminated
1
11.1%
No approval data available
- 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.
