Aura Biosciences Presents Interim Phase 2 Safety Data Evaluating Suprachoroidal Administration of AU-011 in Patients with Choroidal Melanoma at the ASRS 2021 Annual Meeting
12 October 2021 - 11:02PM
UK Regulatory
Arix Bioscience PLC (ARIX) Aura Biosciences Presents Interim
Phase 2 Safety Data Evaluating Suprachoroidal Administration of
AU-011 in Patients with Choroidal Melanoma at the ASRS 2021 Annual
Meeting 12-Oct-2021 / 13:01 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 Aura Biosciences Presents Interim Phase 2
Safety Data Evaluating Suprachoroidal Administration of AU-011 in
Patients with Choroidal Melanoma at the ASRS 2021 Annual Meeting
LONDON, 12 October 2021: Arix Bioscience plc ("Arix", LSE:ARIX), a
global venture capital company focused on investing in and building
breakthrough biotech companies, notes that its portfolio company,
Aura Biosciences, Inc., announced the presentation of interim Phase
2 data with 7 months average follow up evaluating the safety of
suprachoroidal (SC) administration of AU-011, the Company's lead
product candidate for the first-line treatment of primary choroidal
melanoma, as a part of the American Society of Retina Specialists
(ASRS) 2021 Annual Meeting. The announcement can be accessed on
Aura's website at: https://aurabiosciences.com/ and full text of
the announcement from Aura is contained below. [ENDS] For more
information on Arix, please contact: Arix Bioscience plc +44 (0)20
7290 1050 ir@arixbioscience.com Optimum Strategic Communications
Mary Clark, Manel Mateus +44 (0)20 3922 1906
optimum.arix@optimumcomms.com About Arix Bioscience plc Arix
Bioscience plc is a global venture capital company focused on
investing in and building breakthrough biotech companies around
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 BIOSCIENCES PRESS RELEASE
Aura Biosciences Presents Interim Phase 2 Safety Data Evaluating
Suprachoroidal Administration of AU-011 in Patients
with Choroidal Melanoma at the ASRS 2021 Annual Meeting 12
October 2021 CAMBRIDGE, Mass.--- Aura Biosciences, a clinical-stage
oncology company developing a novel class of virus-like drug
conjugate (VDC) therapies for multiple oncology indications, today
announced the presentation of interim Phase 2 data with 7 months
average follow up evaluating the safety of suprachoroidal (SC)
administration of AU-011, the Company's lead product candidate for
the first-line treatment of primary choroidal melanoma, as a part
of the American Society of Retina Specialists (ASRS) 2021 Annual
Meeting. There have been no related serious adverse events, dose
limiting toxicities, or grade 3 adverse events observed during the
study. "These interim data presented today demonstrate that
suprachoroidal administration may improve the therapeutic index and
optimize treatment parameters," said Prithvi Mruthyunjaya, MD, MHS,
Associate Professor of Ophthalmology and Director, Ocular Oncology
Service, Byers Eye Institute at Stanford University, and presenter
of the abstract. "I believe this approach may provide an
opportunity for patients who need a new first line treatment for
early-stage disease, where all current treatments are extremely
invasive and unfortunately result in severe vision loss in many
patients." Phase 2 Trial Design and Timing The Phase 2 trial is
comprised of an open-label, dose escalation phase and a randomized,
masked dose expansion phase that is assessing the safety and
efficacy of ascending single- and repeat-doses of AU-011 via SC
administration, followed by one or two laser applications per
treatment. The randomized, dose expansion portion will be masked,
sham-controlled and is designed to evaluate the safety and efficacy
of the highest dose regimen of AU-011. Cohorts 1-5 have been fully
enrolled (13 patients) and cohort 6 is currently enrolling in the
Phase 2 study. The primary objective of the study is to assess
safety and efficacy of AU-011 via SC administration for purposes of
treating primary indeterminate lesions and choroidal melanoma. The
randomized phase of the trial is planned to begin in the second
half of 2022 in patients with documented growth to establish the
safety and efficacy of AU-011 and serve as the first pivotal trial
for the treatment of indeterminate lesions and choroidal melanoma.
The maximum treatment regimen anticipated for the randomized phase
is three cycles of three weekly treatments of AU-011 at a dose of
80µg with 2 laser administrations. Details from the ASRS 2021
Presentation: Title: A Phase 2 Safety and Efficacy Trial of AU-011,
a Virus-Like Drug Conjugate (VDC), with a Dose Escalation and a
Randomized, Masked Expansion Phase Presenter: Prithvi Mruthyunjaya,
Stanford University Session: Ocular Oncology Symposium Date and
Time: Monday, October 11, 2021 at 4:35pm ET The presentation can be
accessed by visiting the "Presentations" section of "News and
Publications" page of the Aura Biosciences website. About Choroidal
Melanoma Choroidal melanoma is a rare and aggressive type of eye
cancer. Choroidal melanoma is the most common primary intraocular
tumor in adults and develops in the uveal tract of the eye. No
targeted therapies are available at present, and current
radiotherapy treatments can be associated with severe visual loss
and other long-term sequelae such as dry eye, glaucoma, cataracts,
and radiation retinopathy. The most common current treatment is
plaque radiotherapy, which involves surgical placement of a
radiation device on the exterior of the eye over the tumor. The
alternative is enucleation, or total surgical removal of the eye.
Choroidal melanoma metastasizes in approximately 50 percent of
cases with liver involvement in 80-90% of cases and, unfortunately,
metastatic disease is universally fatal (source: OMF). There is a
very high unmet need for a new vision sparing targeted therapy that
could enable early treatment intervention for this life-threatening
rare disease given the mortality rate in metastatic disease, lack
of approved therapies, and the comorbidities of radioactive
treatment options. About AU-011 AU-011 is a first-in-class
virus-like drug conjugate (VDC) therapy in clinical development for
the first line treatment of choroidal melanoma. The virus-like
component of the VDC selectively binds unique heparin sulphate
proteoglycans (HSPGs), which are modified and overexpressed on the
tumor cell surface of malignant cells in the choroid and AU-011
delivers a potent cytotoxic drug that is activated with infrared
light. Upon activation with an ophthalmic laser, the cytotoxic drug
rapidly and specifically disrupts the cell membrane of malignant
cells with a pro-immunogenic cell death that can activate the
immune system generating long term anti-tumor immunity. The unique
specificity of tumor binding by the VDC enables the preservation of
key eye structures, which may allow for the potential of preserving
patients' vision and reducing other long-term complications of
radiation treatment. AU-011 can be delivered using equipment
commonly found in an ophthalmologist's office and does not require
a surgical procedure, pointing to a potentially less invasive, more
convenient therapy for patients and physicians. AU-011 for the
treatment of choroidal melanoma is currently in Phase 2 clinical
development and the company plans to expand the clinical program
into choroidal metastasis. About Suprachoroidal Administration The
suprachoroidal space (SCS^(R)) injection treatment approach offers
unprecedented access to the back of the eye where sight-threatening
disease often occurs. Aura believes that delivering AU-011 into SCS
within the eye, has the potential to offer certain advantages,
including higher bioavailability at the tumor site and reduced
exposure of non-targeted tissues, which may lead to an improved
therapeutic index for AU-011. Collectively, these features could
allow for the treatment of a wider range of tumor sizes, and,
therefore, a larger number of patients. The Company is partnered
with Clearside Biomedical for use of Clearside's SCS
Microinjector(R) for administration of AU-011 into the SCS. In
preclinical research presented as part of the ARVO 2020 virtual
program, AU-011 showed excellent distribution in the SCS, complete
necrosis of tumors following laser activation in an animal model of
choroidal melanoma and no clinical signs of anterior segment or
posterior segment inflammation. About Aura Biosciences Aura
Biosciences, Inc. is a clinical-stage oncology company developing a
novel technology platform based on virus-like drug conjugates
(VDCs) to target and destroy cancer cells selectively while
activating the immune system to create long lasting anti-tumor
immunity. The VDC technology platform is based on the discoveries
of NIH Distinguished Investigator Dr. John Schiller of the Center
for Cancer Research at the National Cancer Institute (NCI). The
company has the goal of developing this technology in multiple
cancer indications with an initial focus in ocular oncology, a
group of rare diseases for which there are no approved drugs.
Aura's lead product candidate belzupacap sarotalocan (AU-011) is
currently in Phase 2 development for the first line treatment of
choroidal melanoma, a vision and life-threatening form of eye
cancer where standard of care radioactive treatments leave patients
with major vision loss and severe comorbidities. AU-011 was well
tolerated in a Phase 1b/2 trial, demonstrating high rates of tumor
control and vision preservation. Future pipeline applications for
Aura's technology include additional ocular oncology indications
like choroidal metastases and solid tumor indications like
non-muscle invasive bladder cancer. Aura is headquartered in
Cambridge, MA. For more information, visit www.aurabiosciences.com
or follow us on Twitter.
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