Arix Bioscience PLC (ARIX) Arix Portfolio Company Aura
Biosciences Presents Interim Phase 2 Data Highlighting Belzupacap
Sarotalocan (AU-011) Suprachoroidal Efficacy and Safety at AAO 2022
03-Oct-2022 / 16:31 GMT/BST Dissemination of a Regulatory
Announcement, transmitted by EQS Group. The issuer is solely
responsible for the content of this announcement.
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Arix Bioscience plc
Arix Portfolio Company Aura Biosciences Presents Interim Phase 2
Data Highlighting Belzupacap Sarotalocan (AU-011) Suprachoroidal
Efficacy and Safety at AAO 2022
LONDON, 3 October 2022: Arix Bioscience plc ("Arix", LSE:ARIX),
a global venture capital company focused on investing in
breakthrough biotechnology companies, is pleased to note that its
portfolio company, Aura Biosciences (NASDAQ: AURA), today announced
that interim Phase 2 data evaluating the safety and efficacy of
suprachoroidal (SC) administration using its first VDC product
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)), were
presented at the American Academy of Ophthalmology (AAO) 2022
Annual Meeting held September 30-October 3, 2022, in Chicago,
IL.
"Preliminary analysis of the data from the Phase 2 trial using
suprachoroidal administration supports tolerability up to three
cycles of therapy and shows a dose-dependent anti-tumor response.
The results provide further clinical evidence to support the
potential use of belzupacap sarotalocan as a novel targeted therapy
in patients with early-stage disease with this targeted route using
suprachoroidal administration," said Dr. Cadmus Rich, Chief Medical
Officer and Head of R&D of Aura Biosciences. "We believe that
the data to date provides proof of concept for an additional
intraocular route of administration and further supports belzupacap
sarotalocan's target product profile."
"The Phase 2 interim safety and efficacy data that was presented
at AAO is very encouraging for patients with primary choroidal
melanoma, as the majority of patients are diagnosed with
early-stage disease and have no vision-preserving treatment
options. Interim data showed a statistically significant reduction
in tumor growth rate and a robust tumor control response with a
high rate of visual acuity preservation at the therapeutic
regimen," said Dr. Ivana Kim, Director of the Ocular Melanoma
Center, Massachusetts Eye and Ear.
The full text of the announcement from Aura is contained below
and can be accessed on Aura's website here.
[ENDS]
For more information on Arix, please contact:
Arix Bioscience plc
+44 (0)20 7290 1050
ir@arixbioscience.com
Powerscourt Group
Sarah MacLeod, Ibrahim Khalil, Nick Johnson
+44 (0)20 7250 1446
arix@powerscourt-group.com
About Arix Bioscience plc
Arix Bioscience plc is a global venture capital company focused
on investing in breakthrough biotech companies aroun d cutting-edge
advances in life sciences.
We collaborate with exceptional entrepreneurs and provide the
capital, expertise and global networks to help accelerate their
ideas into important new treatments for patients. As a listed
company, we are able to bring this exciting growth phase of our
industry to a broader range of investors.
www.arixbioscience.com
Aura Peress Release
Aura Biosciences Announces Interim Phase 2 Data Evaluating
Suprachoroidal Administration of Belzupacap Sarotalocan (AU-011)
for the First-Line Treatment of Patients with Early-Stage Choroidal
Melanoma Presented at AAO 2022
BOSTON--(BUSINESS WIRE)--Oct. 3, 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 that interim Phase 2
data evaluating the safety and efficacy of suprachoroidal (SC)
administration using its first VDC product 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)), were presented at the American Academy
of Ophthalmology (AAO) 2022 Annual Meeting held September
30-October 3, 2022, in Chicago, IL.
"The Phase 2 interim safety and efficacy data that was presented
at AAO is very encouraging for patients with primary choroidal
melanoma, as the majority of patients are diagnosed with
early-stage disease and have no vision-preserving treatment
options. Interim data showed a statistically significant reduction
in tumor growth rate and a robust tumor control response with a
high rate of visual acuity preservation at the therapeutic
regimen," said Dr. Ivana Kim, Director of the Ocular Melanoma
Center, Massachusetts Eye and Ear. "Belzupacap sarotalocan offers a
favorable safety profile supporting the potential to become the
first vision-preserving treatment for early-stage choroidal
melanoma, where patients have had to rely on radiotherapy for the
last few decades."
"Preliminary analysis of the data from the Phase 2 trial using
suprachoroidal administration supports tolerability up to three
cycles of therapy and shows a dose-dependent anti-tumor response.
The results provide further clinical evidence to support the
potential use of belzupacap sarotalocan as a novel targeted therapy
in patients with early-stage disease with this targeted route using
suprachoroidal administration," said Dr. Cadmus Rich, Chief Medical
Officer and Head of R&D of Aura Biosciences. "We believe that
the data to date provides proof of concept for an additional
intraocular route of administration and further supports belzupacap
sarotalocan's target product profile."
The presentation can be accessed on the Company's website:
link
Interim 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
belzupacap sarotalocan up to three cycles of treatment via SC
administration for the first-line treatment of early-stage
choroidal melanoma (IL/CM). 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 ?g/dose). All patients from
Cohort 6 (n=8) received three cycles of therapy at the highest dose
(80 ?g/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. These
endpoints have been discussed with the U.S. Food and Drug
Administration and are planned to be used in the pivotal program.
The results, with an average of six months follow up in patients
that received three cycles of therapy in Cohorts 5 and 6, showed a
statistically significant reduction in the tumor growth rate
(-0.296 mm/yr, p = 0.0007) compared to each patient's documented
growth rate at study entry, and an 88.9% (8/9) tumor control rate.
In addition, the visual acuity preservation rate was 88.9% (8/9) 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
safety profile of belzupacap sarotalocan was generally favorable,
with no dose-limiting toxicities or treatment-related SAEs reported
as of August 19, 2022. 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 belzupacap
sarotalocan 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.
Details for the Virtual Investor Day:
The Company will host a virtual Investor Day today at 11:30 a.m.
Eastern Time to discuss belzupacap sarotalocan, its first VDC
product candidate, for the first-line treatment of patients with
early-stage choroidal melanoma. The Company's executive management
team will be joined by three distinguished ocular oncology thought
leaders:
-- Carol Shields, MD, Chief of the Ocular Oncology Service at
Wills Eye Hospital and Professor ofOphthalmology at Thomas
Jefferson University (USA)
-- Ivana Kim, MD, MBA, Director of the Ocular Melanoma Center,
Massachusetts Eye and Ear & AssociateProfessor of
Ophthalmology, Harvard Medical School (USA)
-- Martine Jager, MD, PhD, Professor of Ophthalmology, Leiden
University (Netherlands) & Past President ofthe International
Society of Ocular Oncology and the Association for Research in
Vision and Ophthalmology
To access the virtual Investor Day, please dial (888) 660-6585
(U.S. and Canada) or (929) 203-0858 (international) at least 10
minutes prior to the start time and refer to conference ID 9748492.
A live video webcast will be available in the Investor section of
the Company's website at
https://ir.aurabiosciences.com/events-and-presentations. A webcast
replay will also be available on the corporate website at the
conclusion of the call.
About Aura Biosciences
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