DJ Portfolio Company Aura Biosciences Announces First Patient Dosed in Global Phase 3 CoMpass Trial
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:
https://ir.aurabiosciences.com/press-releases
[ENDS]
Enquiries
For more information on Arix, please contact:
Arix Bioscience plc
+44 (0)20 7290 1050
ir@arixbioscience.com
Powerscourt Group
Sarah MacLeod, Nick Johnson, Molly Ring
+44 (0)20 7250 1446
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. 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."
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 aurabiosciences.com, or follow us on Twitter and 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 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 businesswire.com: https://www.businesswire.com/news/home/20231207348086/en/
Investor and Media Contact:
Alex Dasalla
Head of Investor Relations and Corporate Communications
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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(END) Dow Jones Newswires
December 08, 2023 02:00 ET (07:00 GMT)
