Adverum Biotechnologies Announces Upcoming Data Presentations at ARVO 2022

Rhea-AI Summary

Adverum Biotechnologies announced that Szilárd Kiss, M.D. will present new analyses from the Phase 1 OPTIC Trial of ADVM-022 in wET AMD at the ARVO 2022 Annual Meeting on May 1, 2022. The trial showed over 80% reduction in annual anti-VEGF injections with the 2E11 dose. New data indicate a correlation between neutralizing antibodies (NAbs) and treatment efficacy. ADVM-022 was well tolerated, with no need for steroids post-treatment. Additionally, on April 18, 2022, Adverum granted stock options to an employee as part of an inducement grant.

Szilárd Kiss, M.D. to present new post-hoc analyses from the Phase 1 OPTIC Trial of ADVM-022 (AAV.7m8-aflibercept) in wet AMD

REDWOOD CITY, Calif., April 19, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that new data from the Phase 1 OPTIC study of ADVM-022 (AAV.7m8-aflibercept) in wet age-related macular degeneration (wet AMD) will be presented during The Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting. As previously reported, the OPTIC trial data demonstrated a greater than 80% reduction in annualized anti-VEGF injections following the 2 X 10^11 vg/eye (2E11) dose in all subjects. New analyses to be presented at ARVO assessed the impact of baseline levels of neutralizing antibodies (NAbs) to AAV.7m8 on ADVM-022 efficacy and safety outcomes. 67% (10/15) of the subjects dosed with ADVM-022 at the 2E11 dose had baseline NAbs titers of <1:125. The reductions in mean annualized injection frequency in patients with baseline NAbs <1:125 were greater than 94%. ADVM-022 was well tolerated at the 2E11 dose for the treatment of wet AMD. At most recent follow-up, subjects dosed at the 2E11 dose did not require topical steroids to treat inflammation. There was no correlation between baseline NAbs and safety events.

Poster Presentation Title: Phase 1 Study of Intravitreal (IVT) Gene Therapy with ADVM-022 for Neovascular AMD (OPTIC Trial): The Role of Neutralizing Antibodies (NAbs)
Presentation: 306 – F0109 (Poster Session)
Session Title: AMD and Diabetic Retinopathy
Date: May 1, 2022
Time: 12:15 PM to 2:15 PM MDT
Presenter: Szilárd Kiss, M.D., Bob and Dolores Hope – Robert M. Ellsworth, M.D. Distinguished Associate Professor in Ophthalmology, Weill Cornell Medical College; Associate Dean, Clinical Compliance, Vice-Chair, Research and Compliance, Weill Cornell Medicine Ophthalmology

Adverum intends to issue a press release concurrent with the presentation and plans to post the data presentation on the Publications page in the Pipeline section of the company’s website.

Inducement Grant

On April 18, 2022, Adverum granted a new employee a stock option to purchase 130,000 shares of Adverum’s common stock pursuant to the inducement grant exception under Nasdaq Rule 5635(c)(4), as an inducement that is material to the employee entering into employment with Adverum. The option has a per share exercise price equal to the closing sales price of Adverum’s common stock on the Nasdaq Stock Market on the grant date, and will vest over four years, subject to the employee’s continued service with Adverum.

About Adverum Biotechnologies

Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is evaluating its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with neovascular or wet age-related macular degeneration (wet AMD). For more information, please visit www.adverum.com.

Forward-looking Statements

Statements contained in this press release regarding events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including risks inherent to, without limitation: Adverum’s novel technology, which makes it difficult to predict the time and cost of product candidate development and regulatory uncertainties; the results of early clinical trials not always being predictive of future results; the potential for future complications or side effects in connection with use of ADVM-022. Additional risks and uncertainties facing Adverum are set forth under the caption “Risk Factors” and elsewhere in Adverum’s Securities and Exchange Commission (SEC) filings and reports, including Adverum’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 29, 2022. All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Inquiries

Anand Reddi
Vice President, Head of Corporate Strategy and External Affairs & Engagement
Adverum Biotechnologies, Inc.
T: 650-649-1358

Or

Laurence Watts
Gilmartin Group
T: 619-916-7620
E: laurence@gilmartinir.com
Source: Adverum Biotechnologies, Inc.

Media

Megan Talon
Associate Director, Corporate Communications
Adverum Biotechnologies, Inc.
T: 650-649-1006
E: mtalon@adverum.com

FAQ

What findings will Adverum present at the ARVO 2022 Annual Meeting regarding ADVM-022?

Adverum will present findings from the Phase 1 OPTIC Trial showing over 80% reduction in annual anti-VEGF injections with ADVM-022 in wet AMD.

When is the presentation about ADVM-022 scheduled at ARVO 2022?

The presentation is scheduled for May 1, 2022, from 12:15 PM to 2:15 PM MDT.

What was the outcome of the Phase 1 OPTIC Trial for ADVM-022?

The trial results indicated a greater than 80% reduction in annualized anti-VEGF injections, with a notable 94% reduction in patients with low baseline NAbs.

What is the significance of neutralizing antibodies in the ADVM-022 trial?

The new analyses assessed how baseline levels of NAbs impact the efficacy and safety of ADVM-022, showing improved outcomes in subjects with low NAbs.

What stock option grant did Adverum announce in April 2022?

On April 18, 2022, Adverum granted a stock option to purchase 130,000 shares as an inducement for a new employee.