Aura Biosciences Reports Topline Data from a Retrospective Study of Belzupacap Sarotalocan (AU-011) versus Plaque Radiotherapy Supporting the Value of a Vision Preserving Therapy for the Treatment of Patients with Early-Stage Choroidal Melanoma
June 22 2022 - 4:30PM
Business Wire
In this Retrospective Matched Case Control
Study, Belzupacap Sarotalocan Achieved Statistically Significant
Vision Preservation Compared to Plaque Radiotherapy, the Current
Standard of Care
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,
reported results from a retrospective, matched case control study.
This retrospective analysis assessed the visual acuity of patients
following treatment with plaque radiotherapy compared with
prospective data on visual acuity in subjects with early-stage
choroidal melanoma treated with belzupacap sarotalocan by
intravitreal administration in the Phase 1b/2 trial
(NCT03052127).
“These results point to the high unmet medical need for a first
line vision preserving therapy for the treatment of early-stage
choroidal melanoma given the high levels of irreversible visual
acuity loss with the current standard of care with radiotherapy,”
said Carol Shields, MD, Chief of the Ocular Oncology Service at
Wills Eye Hospital and Professor of Ophthalmology at Thomas
Jefferson University. “Being able to treat the disease early, avoid
radiotherapy and spare long-term vision loss in many patients, as
well as potentially reducing the risk of metastatic disease, could
represent a paradigm shift in our approach to the treatment of
choroidal melanoma. This would be a significant improvement in the
quality of life for patients with this life-threatening rare
disease.”
Results from the Retrospective Study
Study Design
This retrospective, matched case control study compared visual
acuity outcomes for 43 patients from Aura’s Phase 1b/2 trial
evaluating intravitreal administration of belzupacap sarotalocan in
patients with early-stage choroidal melanoma (AU-011-101,
NCT03052127) to 150 patients from the subject database of a
previously completed and published study where patients with small
choroidal melanoma had been treated with plaque radiotherapy
(Shields, et al. “Visual Outcome and Millimeter Incremental Risk of
Metastasis in 1780 Patients With Small Choroidal Melanoma Managed
by Plaque Radiotherapy.” JAMA Ophthalmology. September 27, 2018).
Both cohorts of patients were at high risk for vision loss due to
having the tumor edge within 3.0 mm of the fovea. The patients were
matched for tumor height, tumor diameter, distance from the fovea
and baseline visual acuity, which are among the core factors that
impact visual acuity after treatment.
Key Findings:
- The vision results of patients with early-stage choroidal
melanoma treated with radiotherapy showed the long term,
progressive and irreversible loss of visual acuity in patients
where tumors were close to the fovea.
- The loss of vision in radiotherapy patients was ≥3 lines in a
majority of patients as early as 2 years and ≥6 lines as early as 3
years.
- We believe the comparison of the belzupacap sarotalocan and
radiotherapy results supports the potential benefit of a targeted
treatment achieving a statistically significant difference in
visual acuity preservation as soon as two years including for both
logMAR (Logarithm of the Minimum Angle of Resolution) vision (p =
0.0094) and change in logMAR vision (p = 0.0323).
- We believe the progressive loss of visual acuity with
radiotherapy observed in this retrospective study underscores the
urgent need for a vision preserving targeted therapy.
- The findings of this retrospective study were consistent with
published clinical data supporting the irreversible loss of visual
acuity after treatment with radiotherapy.
“We are committed to developing the first potential targeted
therapy for patients with early-stage choroidal melanoma. We
believe the visual acuity results of the retrospective matched case
control study are exciting because they support the high unmet
medical need for a long-term vision preserving therapy,” said Dr.
Cadmus Rich, Chief Medical Officer and Head of R&D of Aura
Biosciences. “Belzupacap sarotalocan is currently being evaluated
in a Phase 2 dose escalation clinical trial (AU-011-202,
NCT04417530) using suprachoroidal administration in patients with
early-stage choroidal melanoma. We remain on track to initiate our
pivotal trial by the end of 2022.”
Study Limitations include the retrospective nature and utilizing
a matched case control design. The mean follow-up for patients
treated with belzupacap sarotalocan in this initial analysis was
15.6 months. Due to the retrospective nature of this analysis, it
is hypothesis-generating; no formal conclusions can be drawn. Aura
has also initiated a prospective matched case control study to
further evaluate the long-term visual acuity results of belzupacap
sarotalocan from the Phase 2 trial AU-011-202 using suprachoroidal
administration versus radiotherapy.
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, AU-011 (belzupacap sarotalocan),
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 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
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 belzupacap sarotalocan for the treatment
of cancers including choroidal melanoma and NMIBC and expectations
with respect to 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, 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 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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