Drugs / Belzupacap Sarotalocan
Belzupacap Sarotalocan
also known as
AU-011 · Belzupacap serotalocan · Hpv-np au-011 · Light-activated AU-011 · VIRAL NANOPARTICLE CONJUGATES AU-011 · Vnc au-011
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05483868 | Sep 2022 → Mar 2027 expected | non-invasive bladder urothelial carcinoma | Aura Biosciences | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03052127 | Feb 2017 → Jan 2021 | malignant choroid melanoma | Aura Biosciences | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06643884 | Dec 2024 → Nov 2026 expected | ocular cancer | Aura Biosciences | Recruiting | No outcome recorded |
| Phase 2 | NCT04417530 | Aug 2020 → Apr 2024 | malignant choroid melanoma | Aura Biosciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 33
| Date | Issuer | Release |
|---|---|---|
| 2025-03-24 | Aura Biosciences | Results Positive Data from Phase 1 Trial of Bel-sar in Patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) Presented at the 40th Annual European Association of Urology Congress aurabiosciences.com ↗
Aura Biosciences , Inc. (NASDAQ: AURA), today announced positive data from a completed Phase 1 window of opportunity trial of bel-sar (AU-011) in patients with NMIBC. |
| 2024-10-17 | Aura Biosciences | Results 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 aurabiosciences.com ↗
In patients receiving bel-sar with light activation (n=8), 4 out of 5 patients with low grade disease demonstrated a clinical complete response with no tumor cells remaining on histopathological evaluation. |
| 2024-09-12 | Aura Biosciences | Results Aura Biosciences Reports Positive Phase 2 End of Study Results Evaluating Bel-sar as a First-Line Treatment for Early-Stage Choroidal Melanoma aurabiosciences.com ↗
Visual acuity preservation was achieved in 90% of these 10 patients. |
| 2023-11-09 | Aura Biosciences | Regulatory Aura Biosciences Reports Third Quarter 2023 Financial Results and Provides Clinical Development and Operational Highlights aurabiosciences.com ↗
We are encouraged by the agreement with the FDA under the SPA, as it reinforces the plan for our CoMpass trial and further supports our goal of having the first approved vision-preserving therapy for patients with early-stage choroidal melanoma. |
| 2023-11-06 | Aura Biosciences | Regulatory Aura Biosciences Receives FDA Agreement Under Special Protocol Assessment (SPA) for CoMpass Phase 3 Clinical Trial of Belzupacap Sarotalocan (Bel-sar) in Early-stage Choroidal Melanoma aurabiosciences.com ↗ |
| 2023-03-15 | Aura Biosciences | Regulatory Aura Biosciences Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Clinical Development and Operational Highlights aurabiosciences.com ↗
We are excited that bel-sar was granted Fast Track Designation for choroidal metastasis. |
| 2023-02-16 | Aura Biosciences | Results Aura Biosciences Announces Positive Interim Phase 2 Safety and Efficacy Data of Belzupacap Sarotalocan (Bel-sar) for the First-Line Treatment of Patients with Early-Stage Choroidal Melanoma with Suprachoroidal Administration at the Macula Society 46th Annual Meeting aurabiosciences.com ↗
The data presented today with an average of nine months of follow up for patients treated with three cycles of therapy, show an excellent response to the therapy with 89-100% tumor control. |
| 2022-10-03 | Aura Biosciences | Results Aura Biosciences Announces Interim Phase 2 Data Evaluating Suprachoroidal Administration of Belzupacap Sarotalocan (AU-011) for the First-Line Treatment of Patients with Early-Stage Choroidal Melanoma Presented at AAO 2022 aurabiosciences.com ↗ |
| 2022-09-01 | Aura Biosciences | Results Aura Biosciences to Present Belzupacap Sarotalocan (AU-011) Data from Multiple Studies at the 22nd EURETINA Congress aurabiosciences.com ↗
The results will be presented at the 22 nd EURETINA Congress , being held September 1-4, 2022 , in Hamburg, Germany . |
| 2022-06-30 | Aura Biosciences | Regulatory Aura Biosciences Receives FDA Fast Track Designation for Belzupacap Sarotalocan (AU-011) for the Treatment of Non-Muscle Invasive Bladder Cancer aurabiosciences.com ↗
Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for belzupacap sarotalocan (AU-011), Aura’s first VDC product candidate, for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC). |
| 2022-06-22 | Aura Biosciences | Results Aura Biosciences Reports Topline Data from a Retrospective Study of Belzupacap Sarotalocan (AU-011) versus Plaque Radiotherapy Supporting the Value of a Vision Preserving Therapy for the Treatment of Patients with Early-Stage Choroidal Melanoma aurabiosciences.com ↗
Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported results from a retrospective, matched case control study. |
| 2022-05-26 | Aura Biosciences | Results Aura Biosciences Announces Publication of Preclinical Data of the Combination of VDCs with Immune Checkpoint Inhibitors at the 2022 ASCO Annual Meeting aurabiosciences.com ↗
today announced the publication of preclinical data on AU-011, its first VDC product candidate, in combination with immune checkpoint inhibitors. |
| 2022-05-03 | Aura Biosciences | Results Aura Biosciences Presents Preclinical Data Highlighting AU-011’s Anti-Tumor Activity in Choroidal Metastasis, an Additional Ocular Oncology Indication at the 2022 ARVO Annual Meeting aurabiosciences.com ↗
The results presented today highlight AU-011’s targeted cytotoxicity towards tumor cells derived from the most common cancer types known to metastasize to the choroid. |
| 2022-03-21 | Aura Biosciences | Regulatory Aura Biosciences Announces Orphan Drug Designation Granted to AU-011 by European Commission for the Treatment of Uveal Melanoma (Includes Choroidal Melanoma) aurabiosciences.com ↗ |
| 2022-03-08 | Aura Biosciences | Results Aura Biosciences to Present Preclinical Data Highlighting AU‑011’s Potential to Target a Broad Number of Tumor Types at the 2022 AACR Annual Meeting aurabiosciences.com ↗
The results demonstrate the potential wide applicability of AU-011 in targeting a number of solid tumor types and will be presented as part of the 2022 American Association for Cancer Research (AACR) Annual Meeting, being held April 8-13, 2022 in New Orleans, LA . |
| 2022-02-14 | Aura Biosciences | Results Aura Biosciences to Present Preclinical Data Demonstrating Applicability of AU-011 in Bladder Cancer at the 2022 ASCO Genitourinary Cancer Symposium aurabiosciences.com ↗
Using a panel of human bladder cancer cell lines that represent different stages of the disease, AU-011 demonstrated consistent tumor cell binding and cytotoxicity in vitro. |
| 2021-11-15 | Aura Biosciences | Results Aura Biosciences Presents Final Phase 1b/2 Data for its first Virus-Like Drug Conjugate, AU-011, in Patients with Choroidal Melanoma at the American Academy of Ophthalmology 2021 Annual Meeting aurabiosciences.com ↗
The results are presented as part of the American Academy of Ophthalmology (AAO) 2021 Annual Meeting. |
| 2021-10-11 | Aura Biosciences | Results Aura Biosciences Presents Interim Phase 2 Safety Data Evaluating Suprachoroidal Administration of AU-011 in Patients with Choroidal Melanoma at the ASRS 2021 Annual Meeting aurabiosciences.com ↗
There have been no related serious adverse events, dose limiting toxicities, or grade 3 adverse events observed during the study. |
| 2021-05-03 | Aura Biosciences | Results Aura Biosciences Presents New Preclinical AU-011 Data at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting aurabiosciences.com ↗
New preclinical data presented at the meeting demonstrates the potential of AU-011 for the treatment of choroidal metastases from breast and lung cancer, which are the most common causes of metastases in the choroid. |
| 2021-04-14 | Aura Biosciences | Results Aura Biosciences Announces Publication of Data in Cancer Immunology Research Supporting the Immune Mediated Mechanism of Action of the Virus-Like Drug Conjugate (VDC) Technology Platform aurabiosciences.com ↗ |
| 2020-06-12 | Aura Biosciences | Results Aura Biosciences Presents Updated AU-011 Clinical Data at ARVO 2020 aurabiosciences.com ↗
The updated data demonstrate that multiple administrations of light-activated AU-011 were generally well-tolerated. |
| 2020-02-24 | Aura Biosciences | Results Aura Biosciences Presents Updated Phase 1b/2 Clinical Data for AU-011 at the 43rd Annual Macula Society Meeting aurabiosciences.com ↗ |
| 2019-10-15 | Aura Biosciences | Results Aura Biosciences Announces Updated Phase 1b/2 Clinical Data for AU-011 Presented at the American Academy of Ophthalmology 2019 Annual Meeting aurabiosciences.com ↗ |
| 2019-07-24 | Aura Biosciences | Results Aura Biosciences to Present Long-Term Clinical Data for AU-011 at the 37th Annual Scientific Meeting of the American Society of Retina Specialists aurabiosciences.com ↗
Emerging results from the Phase 1b/2 trial of light-activated AU-011 demonstrate tumor control and visual acuity preservation, warranting continued development of the program. |
| 2019-06-14 | Aura Biosciences | Results Aura Biosciences to Present Interim Phase 1b/2 Clinical Data for AU-011 at the European Society of Ophthalmology 2019 Congress aurabiosciences.com ↗
The data with additional follow up time continues to demonstrate a good tolerability and safety profile of light-activated AU-011 at single and multiple administrations. |
| 2019-03-21 | Aura Biosciences | Results Aura Biosciences to Present Interim Phase 1b/2 Clinical Data for AU-011 at the International Society of Ocular Oncology 2019 Annual Meeting aurabiosciences.com ↗
It is also remarkable that no drug-related severe adverse events, serious adverse events or dose limiting toxicities have been observed in the study to date. |
| 2018-10-29 | Aura Biosciences | Results Aura Biosciences Presents Updated Phase 1b/2 Clinical Data for AU-011 at the American Academy of Ophthalmology 2018 Annual Meeting aurabiosciences.com ↗
The data presented at the meeting show that multiple administrations of light-activated AU-011 are well-tolerated with no related serious adverse events, severe adverse events or dose-limiting toxicities observed. |
| 2018-07-23 | Aura Biosciences | Results Aura Biosciences Presents Interim Phase 1b/2 Data at the American Society of Retina Specialists (ASRS) Annual Meeting aurabiosciences.com ↗
Pre-treatment visual acuity was maintained in all subjects that have been followed for 6 to 12 months. |
| 2018-06-17 | Aura Biosciences | Results Aura Biosciences Announces Update of Clinical Safety and Efficacy Data on Lead Candidate AU-011 for Choroidal Melanoma aurabiosciences.com ↗
Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral capsid conjugates, today announced new interim safety and efficacy data from an open-label Phase 1b/2 study of its lead program, light-activated AU-011 for the treatment of primary choroidal melanoma. |
| 2017-12-14 | Aura Biosciences | Results Aura Biosciences Announces Publication of Preclinical Data Supporting AU-011’s Potent and Selective Anti-cancer Activity in Ocular Melanoma Tumors aurabiosciences.com ↗ |
| 2017-11-11 | Aura Biosciences | Results Aura Biosciences Announces Interim Phase 1b/2 Data on Light-Activated AU-011 for Primary Ocular Melanoma aurabiosciences.com ↗
Interim data presented today at AAO show that the drug candidate was generally well-tolerated, with no serious adverse events reported, in the first six patients at three to six months post-treatment of AU-011. |
| 2017-02-06 | Aura Biosciences | Regulatory Aura Biosciences Receives FDA Clearance of Investigational New Drug Application for Light-activated AU-011 for the Treatment of Ocular Melanoma aurabiosciences.com ↗
Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral nanoparticle conjugates, announced today that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug application (IND) for the company’s lead program, light-activated AU-011 in ocular melanoma (OM). |
| 2015-05-21 | Aura Biosciences | Regulatory FDA Grants Orphan Drug Designation to Aura Biosciences’ Novel Treatment for Uveal Melanoma aurabiosciences.com ↗
Aura Biosciences, a biotech company developing highly tumor-targeted breakthrough therapies for rare cancers, has been granted Orphan Disease Designation by the FDA for its drug AU-011 for the treatment of Uveal Melanoma. |
All press releases naming this drug 46 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | belzupacap sarotalocan | “A Phase 2, Open-Label, Dose Escalation Trial Assessing the Safety, Tolerability, and Treatment Effect of Belzupacap Sarotalocan (AU-011) With Suprachoroidal Administration in...” NCT06643884 ↗1“Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma” NCT04417530 ↗ |
| Known as | AU-011 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06643884 ↗ |
| Known as | Belzupacap serotalocan | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802193 ↗ |
| Known as | Hpv-np au-011 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802193 ↗ |
| Known as | Light-activated AU-011 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03052127 ↗ |
| Known as | VIRAL NANOPARTICLE CONJUGATES AU-011 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802193 ↗ |
| Known as | Vnc au-011 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802193 ↗ |
| Modality | Protein / enzyme biologic | — CHEMBL4802193 ↗ |
| Route | Other | “AU-011 Via Suprachoroidal Administration” NCT04417530 ↗ |