On Track to Initiate Pivotal Trial in
Early-Stage Choroidal Melanoma in Q4 2022
On Track to Submit IND in Choroidal Metastasis
in 2H 2022
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 multiple presentations of data evaluating its first VDC
candidate, belzupacap sarotalocan (AU-011), for the first-line
treatment of patients with early-stage choroidal melanoma
[indeterminate lesions and small choroidal melanoma (IL/CM)]. The
presentations include interim safety data from the ongoing Phase 2
trial using suprachoroidal (SC) administration, final safety and
efficacy data from the Phase 1b/2 trial using intravitreal (IVT)
administration, and preclinical results that highlight belzupacap
sarotalocan’s targeted cytotoxicity towards tumor cells derived
from the most common cancer types known to metastasize to the
choroid, supporting its potential use for the treatment of
choroidal metastases, a key second ocular oncology indication. The
presentation also includes preclinical data that supports the
activity of belzupacap sarotalocan as a single agent as well as in
combination with checkpoint inhibitors, highlighting the
possibility to treat not only primary tumors in the eye but
potentially distant metastases by an abscopal effect. The results
will be presented at the 22nd EURETINA Congress, being held
September 1-4, 2022, in Hamburg, Germany.
“We are excited to present for the first time in Europe the
final safety and efficacy data from the Phase 1b/2 trial evaluating
IVT administration of belzupacap sarotalocan for the treatment of
early-stage choroidal melanoma, along with interim safety data from
the ongoing Phase 2 trial using SC administration. In Europe,
early-stage choroidal melanoma is a high unmet medical need with no
approved therapies. We continue to progress with our Phase 2 SC
trial, and we plan to finalize a decision on the route of
administration and initiate our pivotal program in Q4 of this
year,” said Dr. Cadmus Rich, Chief Medical Officer and Head of
R&D of Aura Biosciences. “Preclinical data that will be
presented at EURETINA provides further evidence that belzupacap
sarotalocan has shown anti-tumor activity across multiple tumor
types that are known to metastasize to the choroid, supporting
clinical development in this second ocular oncology indication. We
look forward to submitting the IND in choroidal metastases in the
second half of this year.”
“I am encouraged by the interim safety data observed in the
Phase 2 suprachoroidal study to date. These results further support
belzupacap sarotalocan’s potential as a vision-preserving first
line treatment option for patients with suspicious pigmented
choroidal lesions whose only option is radiotherapy, which usually
causes severe and irreversible vision loss. Preliminary data from
the dose-escalation phase of the Phase 2 SC trial have shown
minimal inflammation with most adverse events of intraocular
inflammation reported as Grade 1 across all treatment regimens,”
said Dr. Martine Jager, Professor of Ophthalmology at Leiden
University. “Additional preclinical data from a research
collaboration with the University of Leiden (Netherlands)
highlights the possibility of using belzupacap sarotalocan in
combination with immune checkpoint inhibitors to treat not only the
primary lesions in the choroid but also potentially treat distant
lesions by an abscopal effect.”
Details for EURETINA 2022 presentations:
Title: Clinical Evaluation of AU-011, a First-in-Class
Targeted Therapy for Choroidal Melanoma, with Intravitreal or
Suprachoroidal Route of Administration Presenter: Martine
Jager, Professor of Ophthalmology at Leiden University
Session: Miscellaneous Free Paper Session Date/Time:
Friday, September 2, 2022 from 17:14-17:20 CEST
Title: New treatment of melanocytic lesions – AU011
Presenter: Martine Jager, Professor of Ophthalmology at
Leiden University Session: Tumors Date/Time:
Saturday, September 3, 2022 from 8:52-9:02 CEST
The presentations will be available on the “Scientific
Presentations” section of “VDC Platform” page of the Aura
Biosciences website on Saturday, September 3, 2022.
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
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 develop 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.
Aura is headquartered in Cambridge, 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
expected timing of updates on the Company’s data from its Phase 2
and Phase 1b/2 clinical trials and Retrospective Match Case Control
Study of belzupacap sarotalocan (AU-011), the significance of
interim data from the ongoing Phase 2 suprachoroidal study, the
therapeutic potential of belzupacap sarotalocan for the treatment
of cancers including choroidal melanoma and NMIBC and expectations
with respect to the timing of its Phase 2 suprachoroidal study and
pivotal program the clinical development of belzupacap
sarotalocan.
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 Aura’s ongoing clinical trials may not be predictive of final
data and results; 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 Quarterly Report on Form 10-Q for the quarter ended March
31, 2022 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/20220901005152/en/
Investor and Media Contact: Matthew DeYoung Argot
Partners 212-600-1902 | aura@argotpartners.com
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