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 multiple presentations of data evaluating its first VDC, belzupacap sarotalocan (AU-011), for the first-line treatment of patients with early-stage choroidal melanoma (indeterminate lesions and small choroidal melanoma (CM)). The presentations include updated safety results from the Phase 2 trial using suprachoroidal (SC) administration, final safety and efficacy data from the Phase 1b/2 trial using intravitreal (IVT) administration as well as top-line data from the Retrospective Match Case Control study comparing the long-term visual acuity outcomes following treatment with belzupacap sarotalocan versus treatment with plaque brachytherapy, the current standard of care. The results will be presented at the International Society of Ocular Oncology (ISOO) 2022 Bi-Annual Meeting, the largest global ocular oncology meeting, being held June 17-21, 2022, in Leiden, the Netherlands.
“The final safety and efficacy data from the Phase 1b/2 trial using IVT administration, along with the data from the ongoing Phase 2 trial using SC administration, continues to support the value of a vision preserving therapy for the first line treatment of patients with early-stage CM,” said Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura Biosciences. “We remain on track with our Phase 2 SC study and we plan to finalize a decision on the route of administration and initiate our pivotal program before the end of the year. Aura is also excited to share the topline results of the retrospective matched case control study as well.”
Details for ISOO 2022 presentations:
Title: A Phase 1b/2 trial of AU-011, a first-in-class targeted therapy for the treatment of choroidal melanoma via intravitreal administration
Presenter: Carol L. Shields, MD, Wills Eye Hospital and Cadmus C. Rich MD, Aura Biosciences
Session: S17 Other Intraocular Tumors
Date/Time: Monday, June 20, 2022 from 09:32 a.m. - 09:40 a.m. CEST
Title: A Phase 2 trial of a first-in-class targeted therapy for choroidal melanoma via suprachoroidal (SC) administration
Presenter: Ivana K. Kim, MD, Massachusetts Eye and Ear
Session: S13 Uveal Melanoma: Clinic and Case
Date/Time: Sunday, June 19, 2022 from 11:24 a.m. - 11:32 a.m. CEST
Industry Symposium: New Developments in AU-011, an Investigational Virus-Like Drug Conjugate (VDC) for the treatment of Ocular Cancer and Metastatic Disease
Presenter: Cadmus Rich, MD, Chief Medical Officer and Head of R&D Aura Biosciences
Date/Time: Sunday, June 19, 2022 from 12:30 p.m. - 01:15 p.m. CEST
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 (AU-011), consists of a virus-like particle conjugated with an anti-cancer agent. Belzupacap sarotalocan selectively targets and destroys cancer cells and activates 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 develop belzupacap sarotalocan across its ocular oncology franchise including for the treatment of patients with choroidal metastases. In addition, leveraging Aura’s technology platform, Aura is developing belzupacap sarotalocan more broadly across multiple cancers, starting with a planned Phase 1 clinical trial in patients with non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA.
For more information, visit aurabiosciences.com, or follow us on Twitter and LinkedIn.
Forward Looking Statement
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 expected timing of updates on the Company’s data from its Phase 2 and Phase 1b/2 clinical trials and Retrospective Match Case Control Study of belzupacap sarotalocan (AU-011), the therapeutic potential of belzupacap sarotalocan for the treatment of cancers including choroidal melanoma and NMIBC and expectations with respect to the timing of its Phase 2 suprachoroidal study and pivotal program the clinical development of belzupacap sarotalocan .
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; 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; risks, assumptions and uncertainties regarding the impact of the continuing COVID-19 pandemic on Aura’s business, operations, strategy, goals and anticipated timelines; Aura’s ongoing and planned pre-clinical 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 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.
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