Aura Biosciences Announces Positive Interim Phase 2 Safety and Efficacy Data of Belzupacap Sarotalocan (Bel-sar) for the First-Line Treatment of Patients with Early-Stage Choroidal Melanoma with Suprachoroidal Administration
16 Fevereiro 2023 - 9:00AM
Business Wire
Aura Biosciences, Inc. (“Aura”) (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 presentation of positive interim Phase 2 safety and
efficacy data of bel-sar with 9-10 months of follow up evaluating
two key clinical endpoints: tumor control and visual acuity
preservation using the suprachoroidal (SC) route of administration
for the first-line treatment of patients with early-stage choroidal
melanoma (indeterminate lesions and small choroidal melanoma
(IL/CM)). The results were presented at the Macula Society 46th
Annual Meeting held February 15-18, 2023, in Miami, FL.
“The data presented today with an average of nine months of
follow up for patients treated with three cycles of therapy, show
an excellent response to the therapy with 89-100% tumor control. In
addition, the safety profile to date has been favorable with only
one patient losing visual acuity and no treatment-related SAEs or
significant AEs, which is encouraging given that the majority of
these patients had tumors close to the fovea or optic disk and
would have likely experienced severe and irreversible vision loss
with the current standard of care with radiotherapy,” said Dr.
Ivana Kim, Director of the Ocular Melanoma Center, Massachusetts
Eye and Ear. “These latest results strongly support the potential
of bel-sar to be used as a first line treatment option for patients
with early-stage choroidal melanoma.”
“We are excited with the interim efficacy data of the Phase 2
study which strongly supports the assumptions for the success of
the global Phase 3 trial,” said Dr. Cadmus Rich, Chief Medical
Officer of Aura Biosciences. “Collectively, we believe these
interim data provide strong confidence to support the launch of a
global Phase 3 trial which is on track to begin enrollment this
year.”
The presentation can be accessed on the Company’s website:
link
Updated Safety and Efficacy Data from the Ongoing Phase 2
Trial with SC Administration
This Phase 2 trial (NCT04417530) is assessing the safety and
preliminary efficacy of single- and multiple ascending-doses of
bel-sar up to three cycles of treatment via SC administration for
the first-line treatment of early-stage choroidal melanoma. A total
of 20 adult patients have been enrolled in the trial including the
single dose Cohorts 1-3 (n=6) and multiple dose escalation Cohorts
4-6 (n=14). Cohorts 5 and 6 received up to three cycles of therapy,
which was considered the therapeutic regimen for evaluation. One
patient in Cohort 5 (n=3) received two cycles of therapy and two
patients in Cohort 5 received three cycles of therapy (40 μg/dose).
All patients from Cohort 6 (n=8) were assigned to receive three
cycles of therapy at the highest dose (80 μg/dose). One patient
from Cohort 6, who discontinued after one cycle due to unrelated
serious adverse events (SAEs), is not included. All patients in
Cohorts 5 and 6 had active growth at study entry, as an enrichment
strategy to evaluate preliminary efficacy. This group of patients
with active growth treated at the therapeutic regimen of three
cycles was evaluated for tumor growth rate, tumor control, and
visual acuity preservation as the defined clinical endpoints to
evaluate preliminary efficacy. The results, with an average of nine
months of follow up in patients who received three cycles of
therapy in Cohorts 5 and 6, and who match the criteria for the
planned global Phase 3 trial, showed a statistically significant
reduction in the tumor growth rate (-0.289 mm/yr, p = <0.0001)
compared to each patient’s documented growth rate at study entry,
and a 100% (8/8) tumor control rate. In addition, the visual acuity
preservation rate was 88% (7/8) in these cohorts, with the majority
of patients being at high-risk for vision loss with tumors close to
fovea or optic disk. The overall tolerability profile of bel-sar
was generally favorable, with no dose-limiting toxicities,
treatment-related SAEs or significant AEs reported as of January
10, 2023. There was no posterior inflammation and only mild
anterior inflammation (Grade 1) in 20% of the patients.
Treatment-related AEs were predominantly mild and resolved without
sequalae. We believe these interim results indicate that bel-sar
may offer a targeted, vision preserving therapy for the first-line
treatment of primary CM, where 80% of patients are diagnosed early
and have no approved therapies to date.
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 (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 has initiated
activities for the global Phase 3 trial evaluating first-line
treatment of early-stage 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 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
bladder cancer (NMIBC). Aura is headquartered in Boston, MA.
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, non-muscle invasive bladder cancer
and choroidal metastases; any express or implied statements
regarding the Company’s expectations for the Phase 2 and Phase 3
clinical trials of bel-sar for early-stage choroidal melanoma; and
Aura’s expectations regarding the estimated patient populations and
related market opportunities for 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, an
improved quality of life of patients after treatment with bel-sar;
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 bel-sar 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; the risk that interim data
from ongoing clinical trials may not be predictive of final data
from completed 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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version on businesswire.com: https://www.businesswire.com/news/home/20230216005319/en/
Investor and Media:
Alex Dasalla Head of Investor Relations and Corporate
Communications adasalla@aurabiosciences.com
Argot Partners Matthew DeYoung aura@argotpartners.com
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