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Aura Biosciences to Present Interim Phase 1b/2 Clinical Data for AU-011 at the International Society of Ocular Oncology 2019 Annual Meeting

March 21, 2019 Off By BusinessWire

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 Phase 1b/2 clinical trial evaluating the safety and efficacy of
light-activated AU-011, the Company’s lead product candidate for the
primary treatment of primary choroidal melanoma, will be highlighted in
an oral presentation at the International Society of Ocular Oncology
(ISOO) 2019 Annual Meeting being held March 22-26, 2019, in Los Angeles.

“These 18-month safety and efficacy data demonstrate that
light-activated AU-011 is well-tolerated, including with multiple
administrations, and has shown initial evidence of tumor control and
preservation of visual acuity even in high risk patients whose tumors
are close to the fovea and optic disk,” said Ivana K. Kim, M.D.,
Co-Director, Ocular Melanoma Center, Massachusetts Eye and Ear,
Associate Professor of Ophthalmology, Harvard Medical School, and lead
author of the presentation.

“Light-activated AU-011 continues to show a compelling degree of tumor
control, tolerability and vision preservation as a potential first line
treatment option for patients with small choroidal melanoma and
indeterminate lesions, especially given the lack of targeted treatment
options for these patients,” commented Cadmus Rich, M.D., Chief Medical
Officer of Aura. “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. We are excited to share these data
with the medical community at ISOO this year.”

This open-label, multicenter trial is designed to investigate single and
multiple ascending doses of light-activated AU-011 in approximately 52
adult subjects with clinically diagnosed primary choroidal melanoma. The
details for the ISOO 2019 presentation are as follows:

Title: Eighteen Month Results of a Phase 1b/2 Open-Label Clinical
Trial of AU-011 for the Treatment of Small to Medium Choroidal Melanoma
Date
and time: Sunday, March 24, 2019; 11:10-11:15am PT
Location:
The Ritz-Carlton Marina del Rey

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
primary treatment of 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 in 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.