Aura Biosciences Announces First Patient Dosed in Global Phase 3 CoMpass Trial Evaluating the Safety and Efficacy of Belzupacap Sarotalocan (Bel-sar) for First-Line Treatment of Early-Stage Choroidal Melanoma
December 07 2023 - 8:00AM
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 the first patient has been dosed in the global Phase 3
CoMpass trial evaluating the safety and efficacy of bel-sar for the
first-line treatment of adult patients with early-stage choroidal
melanoma.
“Dosing of the first patient in this global Phase 3 trial is a
major milestone for Aura, and for patients with early-stage
choroidal melanoma, a life-threatening rare disease with no
approved targeted therapies,” said Elisabet de los Pinos, Ph.D.,
Chief Executive Officer of Aura. “With the SPA agreement from the
FDA, and a strong endorsement from the ocular oncology community,
we continue to move bel-sar closer to potentially being approved as
a first-line vision preserving treatment for patients living with
this disease.”
The CoMpass trial is designed as a superiority trial comparing
bel-sar versus a sham control. The trial is a global Phase 3,
randomized, multi-center, masked study, intended to enroll
approximately 100 patients randomized 2:1:2 to receive high dose
regimen of bel-sar, low dose regimen of bel-sar with suprachoroidal
(SC) administration or a sham control. Aura received written
agreement from the U.S. Food and Drug Administration (FDA) under a
Special Protocol Assessment (SPA) for the overall design of the
CoMpass trial.
About Aura Biosciences
Aura Biosciences, Inc. is a clinical-stage biotechnology company
developing 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 is enrolling patients in the global Phase 3 trial
evaluating first-line treatment of early-stage choroidal melanoma,
a vision- and life-threatening form of eye cancer where the
standard of care with radiotherapy leaves patients with severe
comorbidities, including significant 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 and muscle invasive bladder
cancer. Aura is headquartered in Boston, MA.
For more information, visit aurabiosciences.com, or follow us on
Twitter and LinkedIn.
Forward-Looking Statements
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, choroidal metastasis, muscle invasive
bladder cancer and non-muscle invasive bladder cancer; any express
or implied statements regarding Aura’s expectations for the Phase 3
clinical trial of bel-sar for early-stage choroidal melanoma; and
the potential approvability of 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,
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; the risk that governmental
authorities may disagree with Aura’s clinical trial designs, even
where Aura has obtained agreement with governmental authorities on
the design of such trials, such as the Phase 3 SPA agreement with
FDA; 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; Aura’s ongoing and
planned preclinical 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: Alex Dasalla Head of Investor
Relations and Corporate Communications
adasalla@aurabiosciences.com
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