Aura Biosciences Receives FDA Fast Track Designation for Belzupacap Sarotalocan (AU-011) for the Treatment of Non-Muscle Invasive Bladder Cancer
June 30 2022 - 7:00AM
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 the U.S. Food and Drug Administration (FDA) has
granted Fast Track designation for belzupacap sarotalocan (AU-011),
Aura’s first VDC product candidate, for the treatment of Non-Muscle
Invasive Bladder Cancer (NMIBC).
“We are pleased that belzupacap sarotalocan has been granted
Fast Track designation. We believe that, given that NMIBC presents
such a high unmet medical need, the opportunity for more frequent
interactions with Division of Oncology at FDA and the potential for
Priority Review will be valuable as we advance further into
clinical development in patients with NMIBC,” said Dr. Mark De
Rosch, Chief Operating Officer and Head of Regulatory Affairs of
Aura.
“NMIBC has no approved targeted therapies, and patients
experience high levels of recurrence and progression, ultimately
leading to cystectomy or the removal of the entire bladder,” said
Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura.
“This milestone supports our goal to advance the development of
belzupacap sarotalocan for patients with NMIBC in need of better
and earlier targeted treatment options with the potential to help
preserve the bladder.”
Aura’s planned Phase 1 clinical trial with belzupacap
sarotalocan in this indication will evaluate the safety and early
proof of mechanism, assess distribution, local necrosis and
evidence of immune activation. Aura expects to initiate the trial
in the second half of 2022, with initial Phase 1 data expected in
2023.
Fast Track designation is an FDA process designed to facilitate
the development of products that address high unmet medical needs
and may expedite the review of drugs intended to treat serious or
life-threatening diseases. Features of Fast Track designation
include opportunities for more frequent interactions with the FDA
review team and, if supported by clinical data, eligibility for
Priority Review. Belzupacap sarotalocan has also been previously
granted Fast Track and Orphan Drug designations by the FDA for the
treatment of choroidal melanoma and is currently in Phase 2
clinical development in this indication.
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 (AU-011),
consists of a virus-like particle conjugated with an anti-cancer
agent. Belzupacap sarotalocan is designed to selectively target and
destroy cancer cells and activate the immune system with the
potential to create long-lasting anti-tumor immunity. Belzupacap
sarotalocan is currently in development for ocular cancers, with an
ongoing Phase 2 dose escalation clinical trial evaluating it as a
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 belzupacap
sarotalocan across its ocular oncology franchise including for the
treatment of patients with choroidal metastases. In addition,
leveraging Aura’s technology platform, Aura is developing
belzupacap sarotalocan more broadly across multiple cancers,
starting with a planned Phase 1 clinical trial in patients with
non-muscle invasive bladder cancer (NMIBC). Aura is headquartered
in Cambridge, MA.
For more information, visit aurabiosciences.com, or follow us on
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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 belzupacap sarotalocan for the treatment
of cancers including choroidal melanoma and NMIBC and expectations
with respect to the clinical development of belzupacap sarotalocan,
including expectations regarding the potential benefits conferred
by Fast Track designation and initiation of a Phase 1 clinical
trial.
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
belzupacap sarotalocan; 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 belzupacap
sarotalocan 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; 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 development
and review 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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Investor and Media Contact: Matthew DeYoung Argot
Partners 212-600-1902 | aura@argotpartners.com
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