Adverum Biotechnologies Announces Upcoming Data Presentations at ASGCT 2022


REDWOOD CITY, Calif., May 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 will be presented during the American Society of Gene & Cell Therapy (ASGCT) 2022 Annual Meeting, being held May 16-19, 2022, in Washington D.C. and virtually.

Key presentations include data from the OPTIC study in wet age-related macular degeneration assessing the impact of baseline levels of neutralizing antibodies (NAbs) to AAV.7m8 on ADVM-022 efficacy and safety outcomes. Other new data relevant to the ADVM-022 development program include non-human primate protein expression data supporting a human equivalent 6 X 10^10 vg/eye (6E10) dose of ADVM-022. As previously disclosed, Adverum intends to initiate a Phase 2 study in the third quarter of 2022. The trial is designed to evaluate the 2 X 10^11 vg/eye dose and a new, lower 6E10 vg/eye dose of ADVM-022, along with new enhanced prophylactic steroid regimens, including local steroids and a combination of local and systemic steroids.

Adverum will also present new data supporting additional indications leveraging their proprietary AAV.7m8 vector platform designed for single intravitreal gene therapy administration including presentations on ADVM-062, a novel gene therapy product candidate being developed for blue cone monochromacy. ADVM-062 received Orphan Drug Designation by the U.S. Food and Drug Administration in January 2022. Additionally, Adverum will present data on a novel capsid, LSV1 and two posters supporting Adverum’s adeno-associated virus (AAV) advanced manufacturing process development platform.

Adverum abstracts being presented at ASGCT are as follows:

Oral Presentation Title: The OPTIC Study of Intravitreal Gene Therapy with ADVM-022 for Neovascular AMD (nAMD): The Role of Neutralizing Antibodies
Abstract Number: 1194
Session: Clinical Trials Spotlight Symposium
Date & Time: May 19, 2022, 9:30 – 9:45 AM ET
Presenter: Szilárd Kiss

Oral Presentation Title: A GLP-Compliant Toxicology and Biodistribution Study of ADVM-062 (AAV.7m8-L-opsin), a Novel Gene Therapy Product Being Developed as a Potential Single Intravitreal Administration for the Treatment of Blue Cone Monochromacy
Abstract Number: 1257
Session: Pharmacology/Toxicology Studies or Assay Development II in Room 102 A/B
Date & Time: May 19, 2022, 10:15 – 10:30 AM ET
Presenter: Kelly Hanna

Oral Presentation Title: Novel Capsid LSV1 Has a Unique 3D Structure at the Loop Substitution Area - Confers Superior Retinal Transduction from Intravitreal Injection
Abstract Number: 1234
Session: Ophthalmic and Auditory Diseases in Salon G
Date & Time: May 19, 2022, 11:30 – 11:45 AM ET
Presenter: Cameron Baker

Poster Presentation Title: Analysis of Ocular Distribution and Cell-Type Specificity for ADVM-062, Gene Therapy for Blue Cone Monochromacy
Poster Number: M-171
Session: Ophthalmic and Auditory Diseases in Hall D
Date & Time: May 16, 2022, 5:30 – 6:30 PM ET
Presenter: Julio Nieves

Poster Presentation Title: Non-Clinical Data Support Efficacy and Tolerability of a Human Equivalent Dose of 6E10 vg/eye of ADVM-022 for the Treatment of Neovascular Age-Related Macular Degeneration
Poster Number: Tu-38
Session: AAV Vectors - Preclinical and Proof-of-concept Studies II in Hall D
Date & Time: May 17, 2022, 5:30 – 6:30 PM ET
Presenter: Kellie Schaefer-Swale

Poster Presentation Title: Evaluating Mass Photometry as a Platform Analytic Tool for Determining Relative Amount of Empty and Full Capsids in Inprocess and Purified AAV Samples
Poster Number: Tu-259
Session: Vector Product Engineering, Development or Manufacturing II in Hall D
Date & Time: May 17, 2022, 5:30 – 6:30 PM ET
Presenter: Alex Tai

Poster Presentation Title: Optimization of HEK293 Suspension Platform for Improved rAAV Titers
Poster Number: Tu-256
Session: Vector Product Engineering, Development or Manufacturing II in Hall D
Date & Time: May 17, 2022, 5:30 – 6:30 PM ET
Presenter: Ali Aghajanirefah

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. Such statements include but are not limited to: statements regarding Adverum’s plans to initiate a Phase 2 trial of ADVM-022 in wet AMD at the 2 X 10^11 vg/eye dose and a new, lower 6 X 10^10 vg/eye dose, in the third quarter of 2022. 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 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

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