Aura Announces Global Phase 3 Trial Design with Suprachoroidal Route of Administration Based on Positive Phase 2 Interim Data of Belzupacap Sarotalocan in Early-Stage Choroidal Melanoma
November 10 2022 - 06:45AM
Business Wire
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 it has initiated startup activities for the global
Phase 3 trial. After presenting positive interim data at the
American Academy of Ophthalmology from its ongoing Phase 2 trial,
Aura has aligned with regulatory agencies and finalized the design
of the global Phase 3 trial. The trial will evaluate the efficacy
and safety of belzupacap sarotalocan (bel-sar) with suprachoroidal
administration, for the first-line treatment of early-stage
choroidal melanoma (CM).
“Finalizing the study design and selecting the optimal route of
administration for the Phase 3 trial are key milestones in
progressing towards a potential approval for bel-sar as a
first-line vision preserving therapy in patients with early-stage
choroidal melanoma,” said Dr. Cadmus Rich, Chief Medical Officer of
Aura Biosciences. “We are pleased to have aligned with regulatory
agencies on the overall Phase 3 trial design, including the primary
and key secondary endpoints. We remain focused on improving the
standard of care for patients with early-stage choroidal melanoma,
a life-threatening disease that has no approved therapies.”
The Phase 3 trial has a three arm randomized and masked design,
where the primary analysis will compare bel-sar to sham. Aura is
planning to enroll approximately 75 adult patients with eary-stage
CM, including patients with indeterminte lesions and small
choroidal melanoma. Patients will be enrolled with documented
growth as an enrichment strategy intended to increase the
efficiency of the trial which will include an adaptive design to
further increase the probability of success.
About Aura Biosciences
Aura Biosciences, Inc. is a clinical-stage biotechnology company
developing virus-like drug conjugates (VDCs), a novel class of
therapies, for the treatment of multiple oncology indications.
Aura’s lead VDC candidate, belzupacap sarotalocan (bel-sar;
AU-011), consists of a virus-like particle conjugated with an
anti-cancer agent. Bel-sar is designed to selectively target and
destroy cancer cells and activate the immune system with the
potential to create long-lasting anti-tumor immunity. Bel-sar is
currently in development for ocular cancers, and Aura has initiated
a global Phase 3 trial evaluating first-line treatment of choroidal
melanoma, a vision- and life-threatening form of eye cancer where
standard of care with radiotherapy leaves patients with severe
comorbidities, including major vision loss. Aura plans to pursue
development of bel-sar across its ocular oncology franchise
including for the treatment of patients with choroidal metastasis.
In addition, leveraging Aura’s technology platform, Aura is
developing bel-sar more broadly across multiple cancers, including
in patients with non-muscle invasive bladder cancer (NMIBC). Aura
is headquartered in Boston, MA.
For more information, visit aurabiosciences.com, or follow us on
Twitter and LinkedIn.
Forward Looking Statement
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, and other federal securities laws. Any statements
that are not statements of historical fact may be deemed to be
forward looking statements. Words such as “may,” “will,” “could”,
“should,” “expects,” “intends,” “plans,” “anticipates,” “believes,”
“estimates,” “predicts,” “projects,” “seeks,” “endeavor,”
“potential,” “continue” or the negative of such words or other
similar expressions that can be used to identify forward-looking
statements. These forward looking statements include express or
implied statements regarding Aura’s future expectations, plans and
prospects, including, without limitation, statements regarding the
therapeutic potential of bel-sar for the treatment of cancers
including choroidal melanoma; any express or implied statements
regarding the Company’s expectations for the Phase 2 and Phase 3
clinical trials of bel-sar; and Aura’s expectations regarding the
estimated patient populations and related market opportunities for
bel-sar.
The forward-looking statements in this press release are neither
promises nor guarantees, and investors should not place undue
reliance on these forward-looking statements because they involve
known and unknown risks, uncertainties, and other factors, many of
which are beyond Aura’s control and which could cause actual
results to differ materially from those expressed or implied by
these forward-looking statements, including, without limitation, an
improved quality of life of patients after treatment with bel-sar;
a potential paradigm shift in the approach to the treatment of
choroidal melanoma; the urgent need for a vision preserving
targeted therapy; the potential of bel-sar compared to the existing
standard of care for patients with choroidal melanoma;
uncertainties inherent in clinical trials and in the availability
and timing of data from ongoing clinical trials; the expected
timing for submissions for regulatory approval or review by
governmental authorities; the risk that the results of Aura’s
clinical trials may not be predictive of future results in
connection with future clinical trials; the risk that interim data
from ongoing clinical trials may not be predictive of final data
from completed clinical trials; whether Aura will receive
regulatory approvals to conduct trials or to market products;
whether Aura’s cash resources will be sufficient to fund its
foreseeable and unforeseeable operating expenses and capital
expenditure requirements; risks, assumptions and uncertainties
regarding the impact of the continuing COVID-19 pandemic on Aura’s
business, operations, strategy, goals and anticipated timelines;
Aura’s ongoing and planned pre-clinical activities; and Aura’s
ability to initiate, enroll, conduct or complete ongoing and
planned clinical trials. These risks, uncertainties, and other
factors include those risks and uncertainties described under the
heading “Risk Factors” in Aura’s most recent Annual Report on Form
10-K and Quarterly Report on Form 10-Q filed with the U.S.
Securities and Exchange Commission (SEC) and in subsequent filings
made by Aura with the SEC, which are available on the SEC’s website
at www.sec.gov. Except as required by law, Aura disclaims any
intention or responsibility for updating or revising any
forward-looking statements contained in this press release in the
event of new information, future developments or otherwise. These
forward-looking statements are based on Aura’s current expectations
and speak only as of the date hereof and no representations or
warranties (express or implied) are made about the accuracy of any
such forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20221110005365/en/
Investor and Media:
Alex Dasalla Head of Investor Relations and Corporate
Communications adasalla@aurabiosciences.com
Argot Partners Matthew DeYoung aura@argotpartners.com
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