Aura Biosciences to Present Updated Belzupacap Sarotalocan (AU-011) Data on Multiple Studies at the International Society of Ocular Oncology 2022 Bi-Annual Meeting
June 17 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 multiple presentations of data evaluating its first VDC,
belzupacap sarotalocan (AU-011), for the first-line treatment of
patients with early-stage choroidal melanoma (indeterminate lesions
and small choroidal melanoma (CM)). The presentations include
updated safety results from the Phase 2 trial using suprachoroidal
(SC) administration, final safety and efficacy data from the Phase
1b/2 trial using intravitreal (IVT) administration as well as
top-line data from the Retrospective Match Case Control study
comparing the long-term visual acuity outcomes following treatment
with belzupacap sarotalocan versus treatment with plaque
brachytherapy, the current standard of care. The results will be
presented at the International Society of Ocular Oncology (ISOO)
2022 Bi-Annual Meeting, the largest global ocular oncology meeting,
being held June 17-21, 2022, in Leiden, the Netherlands.
“The final safety and efficacy data from the Phase 1b/2 trial
using IVT administration, along with the data from the ongoing
Phase 2 trial using SC administration, continues to support the
value of a vision preserving therapy for the first line treatment
of patients with early-stage CM,” said Dr. Cadmus Rich, Chief
Medical Officer and Head of R&D of Aura Biosciences. “We remain
on track with our Phase 2 SC study and we plan to finalize a
decision on the route of administration and initiate our pivotal
program before the end of the year. Aura is also excited to share
the topline results of the retrospective matched case control study
as well.”
Details for ISOO 2022 presentations:
Title: A Phase 1b/2 trial of AU-011, a first-in-class
targeted therapy for the treatment of choroidal melanoma via
intravitreal administration Presenter: Carol L. Shields, MD,
Wills Eye Hospital and Cadmus C. Rich MD, Aura Biosciences
Session: S17 Other Intraocular Tumors Date/Time:
Monday, June 20, 2022 from 09:32 a.m. - 09:40 a.m. CEST
Title: A Phase 2 trial of a first-in-class targeted
therapy for choroidal melanoma via suprachoroidal (SC)
administration Presenter: Ivana K. Kim, MD, Massachusetts
Eye and Ear Session: S13 Uveal Melanoma: Clinic and Case
Date/Time: Sunday, June 19, 2022 from 11:24 a.m. - 11:32
a.m. CEST
Industry Symposium: New Developments in AU-011, an
Investigational Virus-Like Drug Conjugate (VDC) for the treatment
of Ocular Cancer and Metastatic Disease Presenter: Cadmus
Rich, MD, Chief Medical Officer and Head of R&D Aura
Biosciences Date/Time: Sunday, June 19, 2022 from 12:30 p.m.
- 01:15 p.m. CEST
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 selectively targets and destroys
cancer cells and activates 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 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; 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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Investor and Media: Matthew DeYoung Argot Partners
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