Aura Biosciences Announces AU-011 Data From Phase 1b/2 Clinical Trial Selected for Late Breaking Presentation at the Upcoming American Academy of Ophthalmology 2020 Virtual Annual Meeting

Nov. 10, 2020 12:00 UTC


Late Breaker to be Presented by Leading Ocular Oncologist, Carol L. Shields, M.D., Director, Ocular Oncology Service, Wills Eye Hospital

A Total of Three Abstracts Highlighting AU-011 Selected for Presentation


CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Aura Biosciences, Inc., a clinical-stage biopharmaceutical company developing a novel class of tumor targeted therapies for initial application in primary tumors such as choroidal melanoma, today announced that an abstract has been selected as a late breaking presentation as part of the Retina Subspecialty Day at the upcoming American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting, taking place November 14-17, 2020. The abstract details results from the ongoing intravitreal administration Phase 1b/2 clinical study and suprachoroidal administration Phase 2 clinical study evaluating AU-011 in patients with choroidal melanoma.

This late-breaking presentation will be given by Carol L. Shields, M.D., Director, Ocular Oncology Service at Wills Eye Hospital, and Professor of Ophthalmology at Thomas Jefferson University. Other key presentations will be given by Brian P. Marr, M.D., Director, Division of Ophthalmic Oncology, New York-Presbyterian/Columbia Medical Center and Ivana K. Kim, M.D., Co-Director, Ocular Melanoma Center, Massachusetts Eye and Ear, and Associate Professor of Ophthalmology, Harvard Medical School, and will also highlight updated clinical data from Aura’s ongoing Phase 1b/2 AU-011 clinical trial, and the overall development plan including the ongoing Phase 2 study evaluating suprachoroidal administration of AU-011, also in patients with primary choroidal melanoma.

Details for the AAO 2020 presentations are as follows:

Late breaker title: AU-011, a Targeted Therapy for Primary Treatment of Choroidal Melanoma (CM) via Intravitreal (IVT) and Suprachoroidal (SC) Administration
Presenter: Carol S. Shields, MD, Wills Eye Hospital
Session: RET10V
Date and time: Friday, November 13, 2020, from 3:15 – 3:20 PM PT
Location: Virtual Live Meeting Broadcast

Title: AU-011 for Choroidal Melanoma: Trial Update
Presenter: Brian P. Marr, MD, New York-Presbyterian/Columbia Medical Center
Session: PTH05V
Date and time: Friday, November 13, 2020, from 4:02 – 4:07 PM PT
Location: Virtual Live Meeting Broadcast

Title: Update from an Ongoing Phase 1b/2 Open-label Trial with Intravitreal (IVT) AU-011 for Choroidal Melanoma (CM) and Further Development Plan
Presenter: Ivana K. Kim, MD, Massachusetts Eye and Ear
Session: PA034
Date and time: Available on demand Nov 14-15, 2020
Location: Virtual Meeting Live Broadcast

About Choroidal Melanoma

Choroidal melanoma is a rare and life-threatening type of eye cancer. It is the most common primary intraocular cancer in adults and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts, and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of patients with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

About AU-011 (belzupacap sarotalocan)

AU-011 is a first-in-class targeted therapy in development for the treatment of primary choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the cell membrane of malignant tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

About Suprachoroidal Administration

In addition to intravitreal administration, Aura is also investigating AU-011 using the suprachoroidal (SC) route of administration. Aura believes that delivering AU-011 into the suprachoroidal space (SCS) ™ within the eye, has the potential to offer certain advantages over intravitreal injection, including higher bioavailability at the tumor site and reduced exposure of non-targeted tissues, which may lead to an improved therapeutic index for AU-011. Collectively, these features could allow for the treatment of a wider range of tumor sizes, and, therefore, a larger number of patients. The Company is partnered with Clearside Biomedical for use of Clearside’s SCS Microinjector™ for administration of AU-011 into the SCS. In preclinical research presented as part of the ARVO 2020 virtual program, AU-011 showed excellent distribution in the SCS, complete necrosis of tumors following laser activation in an animal model of choroidal melanoma and no clinical signs of anterior segment or posterior segment inflammation.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage biopharmaceutical company developing a new class of oncology therapies based on a novel tumor targeting technology for initial application in primary tumors such as ocular and bladder cancers with the potential to treat other cancers. The Company’s proprietary technology platform utilizes viral-like particle bioconjugates (VPBs) that have a dual selectivity mechanism with targeted binding to cancer cells, followed by activation using a common laser. These potent cytotoxic therapies result in acute tumor cell necrosis, while sparing surrounding healthy tissue and activating the immune system to generate an anti-tumor response. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the treatment of choroidal melanoma, a vision and life-threatening form of eye cancer for which there are currently no approved therapies. In a Phase 1b/2 study, AU-011 demonstrated compelling efficacy, including high rates of tumor control and vision preservation, along with a favorable safety profile, in patients with choroidal melanoma. The development of AU-011 is partially supported by funding awarded under a CRADA from the U.S. National Institutes of Health’s National Cancer Institute. Future pipeline applications for Aura’s technology include choroidal metastases and primary bladder carcinoma. Aura is headquartered in Cambridge, MA. For more information, visit or follow us on Twitter.


Investor and Media Contact:
Joseph Rayne
Argot Partners
617.340.6075 |


Source: Aura Biosciences

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