Aura Biosciences to Present Interim Phase 1b/2 Clinical Data for AU-011 at the European Society of Ophthalmology 2019 Congress

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aura Biosciences, a leader in the development of novel targeted
therapies in ocular oncology, today announced that interim clinical data
from its ongoing Phase 1b/2 clinical trial evaluating the safety and
efficacy of light-activated AU-011, the Company’s lead product candidate
for the treatment of primary choroidal melanoma, will be highlighted in
an oral presentation at the European Society of Ophthalmology 2019
Congress being held June 13-16, 2019, in Nice, France.

“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. There is also consistent evidence of tumor
control and visual acuity preservation, which are key benefits of this
novel treatment,” said Ivana K. Kim, M.D., Co-Director, Ocular Melanoma
Center, Massachusetts Eye and Ear, Associate Professor of Ophthalmology,
Harvard Medical School. “Interest in AU-011 as a potential first line
treatment for early stage disease is very high as current treatments for
primary choroidal melanoma typically result in severe vision loss and
ocular morbidity.”

Oral presentation details are as follows:

Title: Interim Results of a Phase 1b/2 Open-Label Clinical Trial
of AU-011 for the Treatment of Small to Medium Choroidal Melanoma
Presenter:
Ivana K. Kim, M.D., Co-Director, Ocular Melanoma Center, Massachusetts
Eye and Ear and Associate Professor of Ophthalmology, Harvard Medical
School
Session: Innovation in Retina
Date and time:
Friday, June 14, 2019; 3:00-3:12pm CEST
Location: Gallieni
5, Acropolis Convention Centre

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer.
Choroidal melanoma is the most common primary intraocular tumor 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
cases 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 Light-Activated AU-011

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 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 Aura Biosciences

Aura Biosciences is developing a new class of therapies to selectively
target and destroy cancer cells. Its lead program, AU-011 for the
treatment of primary choroidal melanoma, is being developed under a
CRADA with the National Cancer Institute (NCI), part of the National
Institutes of Health. For more information, visit www.aurabiosciences.com.

Contacts

Media:
David Rosen
Argot Partners
212.600.1902 | [email protected]

Investors:
Joseph Rayne
Argot Partners
617.340.6075
| [email protected]