UNCERTAIN AURA DEFINITION TRIAL

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. Any statements that are not statements of historical fact may be deemed to be 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. Aura is headquartered in Boston, MA.įor more information, visit, or follow us on Twitter and LinkedIn. In addition, leveraging Aura’s technology platform, Aura is developing bel-sar more broadly across multiple cancers, including in patients with non-muscle invasive bladder cancer (NMIBC). Aura plans to pursue development of bel-sar across its ocular oncology franchise including for the treatment of patients with choroidal metastasis.

UNCERTAIN AURA DEFINITION TRIAL

Bel-sar is currently in development for ocular cancers, and Aura has initiated a global Phase 3 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. 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. Aura’s lead VDC candidate, belzupacap sarotalocan (bel-sar AU-011), consists of a virus-like particle conjugated with an anti-cancer agent. is a clinical-stage biotechnology company developing virus-like drug conjugates (VDCs), a novel class of therapies, for the treatment of multiple oncology indications. Patients will be enrolled with documented growth as an enrichment strategy intended to increase the efficiency of the trial which will include an adaptive design to further increase the probability of success.Īura Biosciences, Inc. Aura is planning to enroll approximately 75 adult patients with eary-stage CM, including patients with indeterminate lesions and small choroidal melanoma. The Phase 3 trial has a three arm randomized and masked design, where the primary analysis will compare bel-sar to sham. We remain focused on improving the standard of care for patients with early-stage choroidal melanoma, a life-threatening disease that has no approved therapies.” “ We are pleased to have aligned with regulatory agencies on the overall Phase 3 trial design, including the primary and key secondary endpoints. Cadmus Rich, Chief Medical Officer of Aura Biosciences. “ Finalizing the study design and selecting the optimal route of administration for the Phase 3 trial are key milestones in progressing towards a potential approval for bel-sar as a first-line vision preserving therapy in patients with early-stage choroidal melanoma,” said Dr. The trial will evaluate the efficacy and safety of belzupacap sarotalocan (bel-sar) with suprachoroidal administration, for the first-line treatment of early-stage choroidal melanoma (CM).

After presenting positive interim data at the American Academy of Ophthalmology from its ongoing Phase 2 trial, Aura has aligned with regulatory agencies and finalized the design of the global Phase 3 trial. (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 it has initiated startup activities for the global Phase 3 trial. BOSTON–( BUSINESS WIRE)– Aura Biosciences Inc.

Uncertain aura definition