Adverum Biotechnologies Announces New Data at the Macula Society’s 2022 Annual Meeting

Rhea-AI Summary

Adverum Biotechnologies announced new data from the Phase 1 OPTIC study of ADVM-022, a gene therapy for wet AMD, showing therapeutic levels of aflibercept maintained for three years. The study evaluates anatomical outcomes from a single injection of ADVM-022 compared to standard anti-VEGF treatment. Results will be presented at the Macula Society's Annual Meeting on June 9, 2022, highlighting the potential advantages of ADVM-022, such as reduced treatment frequency and improved patient compliance.

Positive

• Therapeutic levels of aflibercept maintained for three years.
• ADVM-022 offers the potential for long-term efficacy and reduced treatment burden.
• Results indicate improved anatomical outcomes compared to standard anti-VEGF therapy.

Negative

• Potential complications or side effects with ADVM-022 remain uncertain.
• Regulatory uncertainties could affect future clinical trials.

- OPTIC study of intravitreal gene therapy with ADVM-022 (AAV.7m8-aflibercept) for wet AMD shows therapeutic levels of aflibercept out to three years
- New evaluation of the impact of baseline levels of neutralizing antibodies (NAbs) to AAV.7m8 on ADVM-022 efficacy, safety and anatomical outcomes

REDWOOD CITY, Calif., June 02, 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 new data from the Phase 1 OPTIC study ADVM-022 (AAV.7m8-aflibercept) development program in wet age-related macular degeneration (wet AMD) will be presented during the Macula Society’s 2022 Annual Meeting in Berlin, Germany. The presentation will include an update on aflibercept protein expression data through three years post-treatment. In addition, a new analysis will compare the anatomical outcomes of a single intravitreal injection of ADVM-022 to standard-of-care bolus anti-vascular endothelial growth factor (VEGF) therapy in patients with wet AMD and will include an evaluation of the impact of baseline levels of neutralizing antibodies (NAbs) to AAV.7m8 on ADVM-022 efficacy, safety, and anatomical measures.

Oral Presentation Title: Improved Anatomical Outcomes in ADVM-022 Treated Subjects Relative to Standard-of-care Bolus anti-VEGF Therapy: Results from the Phase 1 Study of Intravitreal (IVT) Gene Therapy with ADVM-022 for Neovascular AMD (OPTIC Trial)
Session: Genetics & Gene Therapy Session
Date & Time: June 9, 2022, 12:07 – 12:16 PM GMT+2
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 Adverum’s website.

About Wet Age-Related Macular Degeneration

Wet AMD, also known as neovascular AMD or nAMD, is an advanced form of AMD, affecting approximately 10% of patients living with AMD. Wet AMD is a leading cause of blindness in patients over 65 years of age, with a prevalence of approximately 20 million individuals worldwide living with this condition. The incidence of new cases of wet AMD is expected to grow significantly worldwide as populations age. AMD is expected to impact 288 million people worldwide by 2040, with wet AMD accounting for approximately 10% of those cases.

About OPTIC Trial of ADVM-022 in Wet AMD

ADVM-022 is Adverum’s clinical-stage gene therapy product candidate being developed for the treatment of wet AMD. ADVM-022 utilizes a propriety vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. Unlike other ophthalmic gene therapies that require a surgery to administer the gene therapy under the retina (sub-retinal approach) ADVM-022 has the advantage of being administered as a one-time IVT injection in the office and is designed to deliver long-term efficacy and reduce the burden of frequent anti-VEGF injections, optimize patient compliance, and improve vision outcomes for patients with wet AMD.

The OPTIC trial is designed as a multi-center, open-label, dose-ranging, safety and efficacy trial of ADVM-022 in patients with wet AMD who have demonstrated responsiveness to anti-VEGF treatment. Patients in OPTIC are treatment experienced, and previously required frequent anti-VEGF injections to manage their wet AMD and to maintain functional vision.

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. 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 timing of commencement and completion of clinical trials; regulatory uncertainties; the results of early clinical trials not always being predictive of future clinical trials and results; and 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 filed with the SEC on May 12, 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

Investors

Laurence Watts
Gilmartin Group
T: 619-916-7620
E: laurence@gilmartinir.com

Media

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

FAQ

What are the key findings from the OPTIC study of ADVM-022?

The OPTIC study shows therapeutic levels of aflibercept maintained for three years and improved anatomical outcomes compared to standard anti-VEGF therapy.

When will the results of the ADVM-022 study be presented?

Results of the ADVM-022 study will be presented on June 9, 2022, at the Macula Society's Annual Meeting.

What is the significance of the baseline levels of neutralizing antibodies in the ADVM-022 study?

The study evaluates the impact of baseline neutralizing antibodies on the efficacy, safety, and anatomical outcomes of ADVM-022.

How does ADVM-022 differ from traditional treatments for wet AMD?

ADVM-022 is administered as a one-time intravitreal injection, aiming to reduce the frequency of treatments compared to traditional anti-VEGF injections.