belzupacap sarotalocan (AU-011) / Aura Biosci - LARVOL DELTA

Trial in Progress: Safety and Efficacy of Belzupacap Sarotalocan (AU-011), a Virus-Like Drug Conjugate, in Participants with Non-Muscle Invasive Bladder Cancer (NMIBC) (SUO 2025) - P1 | "The trial is actively enrolling at multiple sites, with participants to be distributed across immune-ablative and neoadjuvant treatment cohorts. "

Clinical • Bladder Cancer • Choroidal Melanomas • Eye Cancer • Genito-urinary Cancer • Melanoma • Ocular Melanoma • Oncology • Solid Tumor • Urothelial Cancer • CD4 • CD8

Safety and Efficacy of Bel-sar (AU-011), a Virus-Like Drug Conjugate, in Participants with Non-Muscle Invasive Bladder Cancer (NMIBC) (AUA 2026) - P1 | "Patients will also be monitored for safety.The trial is actively enrolling at multiple sites, with participants to be distributed across immune-ablative and neoadjuvant treatment cohorts. Enrollment is ongoing with continued accrual across cohorts."

Clinical • Bladder Cancer • Choroidal Melanomas • Eye Cancer • Genito-urinary Cancer • Melanoma • Ocular Melanoma • Oncology • Solid Tumor • Urology • Urothelial Cancer • CD4 • CD8

Early Efficacy and Exploratory Biomarker Data of Bel-sar in Patients with Intermediate-risk and High-risk Non-muscle-invasive Bladder Cancer. (PubMed, Eur Urol Open Sci) - "Bel-sar (belzupacap sarotalocan) is a first-in-class virus-like drug conjugate composed of a tumor-targeting virus-like particle linked to a photoactivatable dye, inducing proimmunogenic tumor cell death and antitumor immune response...Bel-sar demonstrated focal administration feasibility, a favorable safety profile, and encouraging preliminary efficacy in NMIBC, with robust immune activation in treated and untreated tumors. These findings support bel-sar's continued development as a therapy combining local tumor eradication with durable immune surveillance."

Biomarker • Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • CD4

A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma (clinicaltrials.gov) - P=N/A | N=100 | Enrolling by invitation | Sponsor: Aura Biosciences | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Choroidal Melanomas • Melanoma • Ocular Melanoma • Oncology • Solid Tumor

AU-011-102: A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer (clinicaltrials.gov) - P1 | N=55 | Active, not recruiting | Sponsor: Aura Biosciences | Recruiting ➔ Active, not recruiting

Enrollment closed • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

CoMpass: 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 (clinicaltrials.gov) - P3 | N=108 | Active, not recruiting | Sponsor: Aura Biosciences | Recruiting ➔ Active, not recruiting

Enrollment closed • Choroidal Melanomas • Eye Cancer • Melanoma • Ocular Melanoma • Oncology • Solid Tumor • Uveal Melanoma

Aura Biosciences…announced it has completed enrollment of 108 patients in the Phase 3 trial evaluating belzupacap sarotalocan (bel-sar) as a frontline treatment for patients with early choroidal melanoma (GlobeNewswire) - "The ongoing CoMpass trial is the first registration-enabling study in patients with early choroidal melanoma. The global, randomized Phase 3 trial is evaluating bel-sar versus sham control in the frontline setting under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA)....Topline data from the 15-month primary endpoint expected in the second half of 2027."

Enrollment closed • P3 data: top line • Choroidal Melanomas

Targeting cancer stem cells with a novel virus-like drug conjugate. (ASCO 2026) - "Funded by Aura Biosciences, National Cancer Insitute Background: Belzupacap sarotalocan (bel-sar) is a novel virus like-drug conjugate in clinical stage development for multiple solid tumors... This study highlights bel-sar's distinctive capacity to target and eradicate CSCs across diverse tumor types. These results support bel-sar's clinical development for local tumor control and suggest bel-sar treatment may be effective against recurring or chemotherapy-resistant tumors."

Cancer stem • IO biomarker • Brain Cancer • Eye Cancer • Genito-urinary Cancer • Glioblastoma • Melanoma • Oncology • Oropharyngeal Cancer • Prostate Cancer • Solid Tumor • Uveal Melanoma • CD24 • CD44 • CXCR4 • POU5F1 • SOX2

Aura Biosciences Announces CEO Transition as Company Advances Phase 3 CoMpass Trial Toward Enrollment Completion (GlobeNewswire) - "The Company also announced that its Phase 3 CoMpass trial with its investigational candidate belzupacap sarotalocan (bel-sar) for the treatment of early choroidal melanoma is nearing enrollment completion. As of today, 86 patients have been enrolled in the study, and more than 25 additional patients have been scheduled or identified for screening through May 2026. With this update, the Company reiterates its guidance to enrollment completion by mid-2026 and topline data from the CoMpass trial in the second half of 2027."

Enrollment status • P3 data: top line • Choroidal Melanomas

Trial to Evaluate the Safety and Feasibility of Belzupacap Sarotalocan (AU-011) for the Treatment of Conjunctival Melanoma, Melanocytic Lesions, or Conjunctival Squamous Cell Carcinoma in adult participants (ANZCTR) - P1 | N=36 | Not yet recruiting | Sponsor: Aura Biosciences, Inc.

New P1 trial • Eye Cancer • Melanoma • Ocular Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma

Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects (clinicaltrials.gov) - P=N/A | N=15 | Recruiting | Sponsor: Aura Biosciences

New trial • Choroidal Melanomas • Eye Cancer • Melanoma • Ocular Melanoma • Oncology • Solid Tumor • Uveal Melanoma

A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma (clinicaltrials.gov) - P=N/A | N=100 | Not yet recruiting | Sponsor: Aura Biosciences

New trial • Choroidal Melanomas • Melanoma • Ocular Melanoma • Oncology • Solid Tumor

AU-011-203: Suprachoroidal Administration in Subjects With Metastases to the Choroid (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Aura Biosciences | Trial completion date: Feb 2027 ➔ Oct 2027 | Trial primary completion date: Mar 2026 ➔ Nov 2026

Trial completion date • Trial primary completion date • Eye Cancer • Ocular Melanoma • Oncology

SUO 2025: Trial in Progress: Safety and Efficacy of Belzupacap Sarotalocan (AU-011), a Virus-like Drug Conjugate, in Participants with Non-Muscle Invasive Bladder Cancer (UroToday)

Trial status • Bladder Cancer

AU-011-102: A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer (clinicaltrials.gov) - P1 | N=55 | Recruiting | Sponsor: Aura Biosciences | Trial primary completion date: Dec 2026 ➔ Mar 2027

Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

CoMpass: 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 (clinicaltrials.gov) - P3 | N=100 | Recruiting | Sponsor: Aura Biosciences | Trial completion date: Mar 2027 ➔ Aug 2028 | Trial primary completion date: Mar 2026 ➔ Nov 2027

Trial completion date • Trial primary completion date • Choroidal Melanomas • Eye Cancer • Melanoma • Ocular Melanoma • Oncology • Solid Tumor • Uveal Melanoma

Additional Phase 1 Biological Activity Data Presented at the 45th Congress of the Société Internationale d’Urologie (SIU) (GlobeNewswire) - "Multiplex immune fluorescence data from the Phase 1 trial of bel-sar demonstrating robust induction of adaptive immune memory in patients with non-muscle invasive bladder cancer (NMIBC) were presented....These multiplex immune fluorescence data (n=5 patients from the Phase 1 trial) further characterize the previously announced results from the Company’s completed Phase 1 clinical trial of bel-sar in patients with NMIBC....In treated lesions, natural killer cell density increased up to 40x, CD4+ cytolytic T cell density increased up to 7x, and CD4+ and CD8+ memory T cells were observed after bel-sar treatment."

P1 data • Bladder Cancer

Ongoing Phase 3 CoMpass Trial (GlobeNewswire) - "...The Company currently expects that it can complete CoMpass enrollment in 2026 and provide topline data readout for the 15-month primary endpoint in the fourth quarter of 2027."

Enrollment status • P3 data: top line • Choroidal Melanomas • Uveal Melanoma

Ongoing Phase 1b/2 Trial (GlobeNewswire) - "This trial will evaluate additional doses and cycles of bel-sar in approximately 26 intermediate and high-risk NMIBC patients. Patients will be monitored for response assessments and recurrence at 3, 6, 9, and 12 months. This trial is actively enrolling and remains on track, with initial three-month clinical data expected in mid-2026."

P1/2 data • Trial status • Bladder Cancer

Metastases to the Choroid (GlobeNewswire) - "The Company has dosed the first patient in an ongoing Phase 2 clinical trial in metastases to the choroid. A protocol amendment has now been implemented to expand the entry criteria to include all metastases arising from different solid tumors to facilitate enrollment into the study and broaden the proof of concept for bel-sar in this indication....With a four-week efficacy endpoint, the Company expects early proof of concept data from this trial in 2026."

P2 data • Trial status • Solid Tumor

Cancers of the Ocular Surface (GlobeNewswire) - "The Company is planning to initiate a Phase 1 proof-of-concept trial to assess safety, feasibility and tumor response through histopathologic evaluation at a 2–4-week time point. Development activities for this program remain on track, with early proof of concept data from Australian clinical sites expected in 2026."

Clinical data • New P1 trial • Eye Cancer

SYMP-27: Safety and Efficacy of AU-011, a Virus-Like Drug Conjugate, in Participants with NMIBC (SIU 2025) - No abstract available

Clinical • Bladder Cancer • Oncology

NMIBC: A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer (clinicaltrials.gov) - P1 | N=55 | Recruiting | Sponsor: Aura Biosciences | N=21 ➔ 55 | Trial completion date: Jul 2024 ➔ Apr 2027 | Trial primary completion date: Jun 2024 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

AU-011-203: Suprachoroidal Administration in Subjects With Metastases to the Choroid (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Aura Biosciences | Not yet recruiting ➔ Recruiting

Enrollment open • Eye Cancer • Ocular Melanoma • Oncology

Clearside Biomedical Announces Multiple Presentations to be Featured at the Clinical Trials at the Summit Meeting (GlobeNewswire) - "Clearside Biomedical, Inc...announced today that the use of its SCS delivery platform will be featured in multiple presentations at the Clinical Trials at the Summit (CTS) Meeting on June 21, 2025 in Las Vegas, Nevada."

Clinical data • Age-related Macular Degeneration • Choroidal Melanomas • Diabetic Retinopathy