BOSTON - 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.

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.

Contact:

Alex Dasalla

Email: adasalla@aurabiosciences.com

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