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AURA BIOSCIENCES

🇮🇳India
Ownership
-
Employees
-
Market Cap
$378.4M
Website

Clinical Trials

7

Active:0
Completed:2

Trial Phases

3 Phases

Phase 1:2
Phase 2:2
Phase 3:1

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (5 trials with phase data)• Click on a phase to view related trials

Phase 1
2 (40.0%)
Phase 2
2 (40.0%)
Phase 3
1 (20.0%)

Suprachoroidal Administration in Subjects With Choroidal Metastasis From Breast or Lung Primary Tumors

Phase 2
Not yet recruiting
Conditions
Eye Cancer
Metastatic Breast Cancer
Lung Cancer
Interventions
Device: SCS Microinjector
Device: Laser
First Posted Date
2024-10-16
Last Posted Date
2024-10-17
Lead Sponsor
Aura Biosciences
Target Recruit Count
24
Registration Number
NCT06643884
Locations
🇺🇸

Byers Eye Institute at Stanford University, Palo Alto, California, United States

🇺🇸

Bascom Palmer Eye Institute, Miami, Florida, United States

🇺🇸

Massachusetts Eye and Ear, Boston, Massachusetts, United States

and more 6 locations

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

Phase 3
Recruiting
Conditions
Ocular Melanoma
Uveal Melanoma
Choroidal Melanoma
Indeterminate Lesions
Interventions
Device: Sham Infrared Laser
Device: Suprachoroidal Microinjector
Device: Sham Microinjector
Device: Infrared Laser
First Posted Date
2023-08-23
Last Posted Date
2025-04-17
Lead Sponsor
Aura Biosciences
Target Recruit Count
100
Registration Number
NCT06007690
Locations
🇨🇿

Fakultni Thomayerova nemocnice, Praha 4, Krč, Czechia

🇩🇪

Charité - Universitätsmedizin Berlin KöR, Berlin, Germany

🇩🇪

Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde, Lübeck, Germany

and more 51 locations

A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer

Phase 1
Recruiting
Conditions
Non-muscle-invasive Bladder Cancer
Muscle-Invasive Bladder Carcinoma
Interventions
Combination Product: AU-011 in Combination with Medical Laser Adminstration
Combination Product: AU-011 in Combination with Medical Laser Administration
First Posted Date
2022-08-02
Last Posted Date
2024-06-12
Lead Sponsor
Aura Biosciences
Target Recruit Count
21
Registration Number
NCT05483868
Locations
🇺🇸

Arkansas Urology, Little Rock, Arkansas, United States

🇺🇸

Saint John's Cancer Institute, Santa Monica, California, United States

🇺🇸

Montefiore Medical Center, Bronx, New York, United States

and more 6 locations

Prospective Group-Matched Study With Belzupacap Sarotalocan (Bel-sar; AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)

Terminated
Conditions
Choroidal Melanoma
Indeterminate Lesions
Interventions
Other: Standard of Care
First Posted Date
2022-03-04
Last Posted Date
2023-08-09
Lead Sponsor
Aura Biosciences
Target Recruit Count
2
Registration Number
NCT05266430
Locations
🇺🇸

Associated Retinal Consultants, P.C., Royal Oak, Michigan, United States

🇺🇸

Oregon Health & Science University Casey Eye Institute, Portland, Oregon, United States

🇺🇸

Retina Consultants of Carolina, PA, Greenville, South Carolina, United States

and more 4 locations

Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Phase 2
Completed
Conditions
Uveal Melanoma
Ocular Melanoma
Choroidal Melanoma
Interventions
Device: Suprachoroidal Microinjector
Device: PDT Laser
First Posted Date
2020-06-04
Last Posted Date
2025-03-03
Lead Sponsor
Aura Biosciences
Target Recruit Count
22
Registration Number
NCT04417530
Locations
🇺🇸

Retina Associates SW, P.C., Tucson, Arizona, United States

🇺🇸

UCLA Jules Stein Eye Institute, Los Angeles, California, United States

🇺🇸

Byers Eye Institute at Stanford University, Palo Alto, California, United States

and more 19 locations
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News

Aura Biosciences to Present New Phase 1 Data for Bel-sar in Bladder Cancer at EAU 2025

• 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 Advances Bel-Sar in Multiple Clinical Trials for Ocular and Bladder Cancers

• 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' Bel-sar Shows Promise in Choroidal Melanoma and Bladder Cancer Trials

• 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 Shows Promise in Early-Stage Bladder Cancer Trial

• 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.

Aura Biosciences' Bel-Sar Shows Promise in Phase 2 for Early-Stage Choroidal Melanoma

• 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.

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