REG-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

Arix BioscienceAnnouncement

03/10/2022 16:45

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   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  1 here.

    

                                      ENDS 

   For more information on Arix, please contact:

    

   Arix Bioscience plc

   +44 (0)20 7290 1050

    2 ir@arixbioscience.com  

    

   Powerscourt Group

   Sarah MacLeod, Ibrahim Khalil, Nick Johnson

   +44 (0)20 7250 1446

    3 arix@powerscourt-group.com

    

   About Arix Bioscience plc

   Arix Bioscience  plc  is  a  global venture  capital  company  focused  on
   investing in 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 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:  5 link

   Interim Safety and Efficacy Data from the Ongoing Phase 2 Trial with SC
   Administration

   This Phase 2 trial ( 6 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 μg/dose). All patients from Cohort 6 (n=8)
   received 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. 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 of Ophthalmology at Thomas Jefferson
       University (USA)
     • Ivana Kim, MD, MBA, Director of the Ocular Melanoma Center,
       Massachusetts Eye and Ear & Associate Professor of
       Ophthalmology, Harvard Medical School (USA)
     • Martine Jager, MD, PhD, Professor of Ophthalmology, Leiden
       University (Netherlands) & Past President of the 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  7 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

   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. Belzupacap
   sarotalocan is designed to selectively target and destroy cancer cells and
   activate 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 metastasis. In addition, leveraging Aura’s
   technology platform, Aura is developing belzupacap sarotalocan more
   broadly across multiple cancers, including in patients with non-muscle
   invasive bladder cancer (NMIBC). Aura is headquartered in Boston, MA.

   For more information, visit  8 aurabiosciences.com, or follow us on
   Twitter and LinkedIn.

    

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   ISIN:           GB00BD045071
   Category Code:  PFU
   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.:   192093
   EQS News ID:    1455685


    
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