REG-Arix Bioscience PLC Portfolio Company Aura Biosciences Announces First Patient Dosed in Global Phase 3 CoMpass Trial

Arix BioscienceAnnouncement

08/12/2023 07:15

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Arix Bioscience PLC (ARIX)
Portfolio Company Aura Biosciences Announces First Patient Dosed in Global Phase 3
CoMpass Trial

08-Dec-2023 / 07:00 GMT/BST

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                                 Arix Bioscience plc

                                           

  Portfolio Company Aura Biosciences Announces First Patient Dosed in Global Phase 3
 CoMpass Trial Evaluating the Safety and Efficacy of Belzupacap Sarotalocan (Bel-sar)
              for First-Line Treatment of Early-Stage Choroidal Melanoma

                                           

LONDON, 8 December 2023: Arix Bioscience plc (“Arix”) (LSE: ARIX), a transatlantic
venture capital company focused on investing in breakthrough biotechnology companies,
notes that its Core Portfolio company, Aura Biosciences (“Aura”) (NASDAQ: AURA) has
announced that the first patient has been dosed in the global Phase 3 CoMpass trial
evaluating the safety and efficacy of bel-sar for the first-line treatment of adult
patients with early-stage choroidal melanoma.

Arix holds 1,508,483 shares in Aura. The holding value of these shares will continue
to be determined by the market price of Aura’s shares.

 

Robert Lyne, CEO  of Arix, commented:  “We are pleased  to see Aura  reach this  major
milestone and progress  into phase  3 trials.  It is  a great  example of  how we  can
support innovative biotech companies in bringing life changing treatments to patients.
Choroidal melanoma  is a  vision and  life-threatening form  of eye  cancer where  the
standard  of  care  with  radiotherapy  leaves  patients  with  severe  comorbidities,
including significant vision loss. We look forward  to seeing further updates as  they
progress through the clinic.”

 

The full text  from Aura’s announcement  is reproduced  below and can  be accessed  on
the Aura Biosciences website here:  1 https://ir.aurabiosciences.com/press-releases

 

                                         ENDS 

 

Enquiries

For more information on Arix, please contact:

 

Arix Bioscience plc

+44 (0)20 7290 1050

ir 2 @arixbioscience.com

 

Powerscourt Group

Sarah MacLeod, Nick Johnson, Molly Ring

+44 (0)20 7250 1446

 3 arix@powerscourt-group.com

 

 

About Arix Bioscience plc

Arix Bioscience plc is a transatlantic venture capital company focused on investing in
breakthrough biotechnology 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:

 

BOSTON--(BUSINESS WIRE)--Dec. 7, 2023-- 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 the first
patient has been dosed in the global Phase 3 CoMpass trial evaluating the safety and
efficacy of bel-sar for the first-line treatment of adult patients with early-stage
choroidal melanoma.

 

“Dosing of the first patient in this global Phase 3 trial is a major milestone for
Aura, and for patients with early-stage choroidal melanoma, a life-threatening rare
disease with no approved targeted therapies,” said Elisabet de los Pinos, Ph.D., Chief
Executive Officer of Aura. “With the SPA agreement from the FDA, and a strong
endorsement from the ocular oncology community, we continue to move bel-sar closer to
potentially being approved as a first-line vision preserving treatment for patients
living with this disease.”

 

 5 The CoMpass trial is designed as a superiority trial comparing bel-sar versus a
sham control. The trial is a global Phase 3, randomized, multi-center, masked study,
intended to enroll approximately 100 patients randomized 2:1:2 to receive high dose
regimen of bel-sar, low dose regimen of bel-sar with suprachoroidal (SC)
administration or a sham control. Aura received written agreement from the U.S. Food
and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the
overall design of the CoMpass trial.

 

 

About Aura Biosciences

 

Aura Biosciences, Inc. is a clinical-stage biotechnology company developing 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 is enrolling patients in the global Phase 3 trial evaluating
first-line treatment of early-stage choroidal melanoma, a vision- and life-threatening
form of eye cancer where the standard of care with radiotherapy leaves patients with
severe comorbidities, including significant 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 and muscle invasive bladder cancer.
Aura is headquartered in Boston, MA.

For more information, visit  6 aurabiosciences.com, or follow us
on  7 Twitter and  8 LinkedIn.

 

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, choroidal
metastasis, muscle invasive bladder cancer and non-muscle invasive bladder cancer; any
express or implied statements regarding Aura’s expectations for the Phase 3 clinical
trial of bel-sar for early-stage choroidal melanoma; and the potential approvability
of 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, 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; the risk that governmental authorities may disagree with Aura’s clinical trial
designs, even where Aura has obtained agreement with governmental authorities on the
design of such trials, such as the Phase 3 SPA agreement with FDA; 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; Aura’s ongoing and planned preclinical
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  9 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.

 

View source version
on  10 businesswire.com:  11 https://www.businesswire.com/news/home/20231207348086/en/

 

Investor and Media Contact:

Alex Dasalla
Head of Investor Relations and Corporate Communications
 12 adasalla@aurabiosciences.com

Source: Aura Biosciences Inc.

 

 

 

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Dissemination of a Regulatory Announcement, transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.

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   ISIN:           GB00BD045071
   Category Code:  MSCM
   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.:   290660
   EQS News ID:    1792521


    
   End of Announcement EQS News Service

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  12. mailto:adasalla@aurabiosciences.com


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