Aura Biosciences to Present Phase 2 Safety Data Evaluating Suprachoroidal Administration of Belzupacap Sarotalocan (AU-011) in Patients with Choroidal Melanoma at the ESMO 2022 Congress

Rhea-AI Summary

Aura Biosciences Inc. (NASDAQ: AURA) recently announced that Phase 2 data for its first virus-like drug conjugate (VDC), belzupacap sarotalocan (AU-011), will be presented at the ESMO 2022 Congress, taking place from September 9-13 in Paris. The presentation will focus on the safety of suprachoroidal administration for treating early-stage choroidal melanoma. The company aims to enhance treatment options for this severe form of eye cancer, currently in a dose escalation trial. Additional developments are planned for other oncology applications.

Positive

• Presentation of promising Phase 2 data for AU-011 at a major congress.
• Potential to advance treatment for early-stage choroidal melanoma.

Negative

• No immediate financial metrics or outcomes from the Phase 2 trial were disclosed.
• Dependence on successful clinical trial outcomes for future development.

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- 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 that Phase 2 data evaluating the safety of suprachoroidal administration using its first VDC product candidate, belzupacap sarotalocan (AU-011), for the first-line treatment of patients with early-stage choroidal melanoma (indeterminate lesions and small choroidal melanoma (IL/CM)) will be presented at the ESMO 2022 Congress, being held September 9-13, 2022, in Paris, France.

Details for ESMO 2022 poster presentation:

Title: A Phase 2 Trial of AU-011, an Investigational, Virus-Like Drug Conjugate (VDC) for the Treatment of Primary Indeterminate Lesions and Small Choroidal Melanoma (IL/CM) using Suprachoroidal Administration
Presenter: Hakan Demirci, University of Michigan
Session: Melanoma and Other Skin Tumors
Presentation #: 842P
Date/Time: Saturday, September 10, 2022, at 2:15 p.m. CEST

The presentation will be available on the “Scientific Presentations” section of “VDC Platform” page of the Aura Biosciences website on Saturday, September 10, 2022.

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 clinical trials of belzupacap sarotalocan (AU-011).

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 June 30, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220907005542/en/

Investor and Media Contact:

Matthew DeYoung

Argot Partners

212-600-1902 | aura@argotpartners.com

Source: Aura Biosciences Inc.

FAQ

What is the significance of the Phase 2 trial for AURA's AU-011?

The Phase 2 trial evaluates the safety of AU-011 for treating early-stage choroidal melanoma, which is critical for further development.

When will the Phase 2 data for AU-011 be presented?

The data will be presented on September 10, 2022, at the ESMO 2022 Congress.

What is choroidal melanoma and why is AU-011 important?

Choroidal melanoma is a life-threatening eye cancer, and AU-011 aims to offer a better treatment option with fewer side effects compared to current therapies.

What are the next steps for AURA following the ESMO presentation?

AURA will likely continue to evaluate clinical trial data, seek regulatory approvals, and potentially expand trials for other cancers.

What is the stock symbol for Aura Biosciences?

The stock symbol for Aura Biosciences is AURA.