Aura Biosciences to Present Preclinical Data Demonstrating Applicability of AU-011 in Bladder Cancer at the 2022 ASCO Genitourinary Cancer Symposium

Rhea-AI Summary

Aura Biosciences (NASDAQ: AURA) announced its upcoming Phase 1 clinical trial for AU-011, a virus-like drug conjugate targeting Non-Muscle Invasive Bladder Cancer (NMIBC). This follows the presentation of promising preclinical data at the 2022 ASCO Genitourinary Cancer Symposium. AU-011 shows consistent tumor cell binding and cytotoxicity, indicating its potential efficacy across all tumor grades. The trial is set to begin in the second half of 2022, focusing on addressing the unmet need for effective treatments in NMIBC.

Positive

• Initiation of Phase 1 clinical trial for AU-011 planned in 2H 2022.
• Promising preclinical data indicating AU-011's efficacy in NMIBC.
• Demonstrated tumor cell binding and cytotoxicity in various bladder cancer cell lines.

Negative

• None.

Company on Track to Initiate Phase 1 Clinical Trial in 2H 2022

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 the presentation of preclinical data for its first VDC product candidate, AU-011, which is being developed for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC). The results will be presented as part of the 2022 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancer Symposium being held February 17-19 in San Francisco, CA and online.

“Non-muscle invasive bladder cancer remains an area of high unmet need with high levels of recurrence and progression and no approved targeted therapies. We believe that AU-011’s mechanism of action supports its potential use as a front-line treatment following initial diagnosis and/or for Bacillus Calmette-Guerin (BCG) refractory disease,” said Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura Biosciences. “These preclinical data further support AU-011’s potential in treating urothelial cancer, including NMIBC. We look forward to initiating our planned Phase 1 clinical trial in the second half of this year.

Demonstration of AU-011 Applicability in Urothelial Cancer

Using a panel of human bladder cancer cell lines that represent different stages of the disease, AU-011 demonstrated consistent tumor cell binding and cytotoxicity in vitro. These data support that AU-011’s targeting of bladder cancer cells through HSPGs is tumor grade agnostic. Tumor binding and distribution of AU-011 was evident in both ex vivo human bladder cancer tissues and in an in vivo murine bladder cancer model. Collectively, these results support further investigation of the use of AU-011 in patients with urothelial neoplasia.

Details for the poster presentation are as follows:

Title: Targeting Urothelial Neoplasia Using an Investigational Virus-Like Drug Conjugate
Presenter: Rhonda C. Kines, Aura Biosciences
Poster Session: Urothelial Carcinoma, poster #514
Date and time: Friday, February 18 at 3:30 PM PT
Location: On Demand

The poster can be accessed by visiting the “Scientific Presentations” section of “VDC Platform” page of the Aura Biosciences website.

About Aura Biosciences

Aura Biosciences, Inc. (NASDAQ: AURA) 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, AU-011 (belzupacap sarotalocan), consists of a virus-like particle conjugated with an anti-cancer agent. AU-011 selectively targets and destroys cancer cells and activates the immune system with the potential to create long-lasting anti-tumor immunity. AU-011 is currently in development for ocular cancers, with an ongoing Phase 2 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 AU-011 across its ocular oncology franchise including for the treatment of patients with choroidal metastases. In addition, leveraging Aura’s technology platform, Aura is developing AU-011 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 therapeutic potential of AU-011 for the treatment of NMIBC and expectations with respect to the anticipated timing of AU-011’s Phase 1 clinical trial and further clinical development plans.

The forward-looking statements in this press release are neither promises nor guarantees, and you 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 most recent 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/20220214005717/en/

Investor and Media Contact:

Matthew DeYoung

Argot Partners

212-600-1902 | aura@argotpartners.com

Source: Aura Biosciences Inc.

FAQ

What is the focus of Aura Biosciences' Phase 1 clinical trial?

The Phase 1 clinical trial will focus on AU-011, a treatment for Non-Muscle Invasive Bladder Cancer (NMIBC).

When is the Phase 1 clinical trial for AU-011 expected to start?

The Phase 1 clinical trial for AU-011 is expected to start in the second half of 2022.

What were the results of the preclinical studies for AU-011?

The preclinical studies showed consistent tumor cell binding and cytotoxicity across various bladder cancer cell lines.

What is the significance of AU-011's mechanism of action?

AU-011's mechanism of action targets bladder cancer cells, providing a potential front-line treatment for NMIBC and addressing a significant unmet medical need.