REG-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

Arix BioscienceAnnouncement

12/10/2021 13:05

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   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:
    1 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
    2 ir@arixbioscience.com  

   Optimum Strategic Communications
   Mary Clark, Manel Mateus
   +44 (0)20 3922 1906
    3 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.  4 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  5 www.aurabiosciences.com or follow us on  6 Twitter.

    

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   ISIN:           GB00BD045071
   Category Code:  MSCH
   TIDM:           ARIX
   LEI Code:       213800OVT3AHQCXNIX43
   OAM Categories: 3.1. Additional regulated information required to be
                   disclosed under the laws of a Member State
   Sequence No.:   124087
   EQS News ID:    1240098


    
   End of Announcement EQS News Service

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