Adverum Biotechnologies will host a webcast on November 18th to present key clinical data and program design.
Quiver AI Summary
Adverum Biotechnologies, Inc. announced an investor and analyst webcast on November 18th at 7:30 a.m. EST, where they will present 52-week LUNA phase 2 clinical data and 4-year OPTIC clinical data regarding their gene therapy product candidate, ixoberogene soroparvovec (Ixo-vec), for treating wet age-related macular degeneration (wet AMD). This condition affects around 20 million people globally and is a leading cause of blindness, particularly in those over 65. Ixo-vec, which requires only a single intravitreal injection, aims to provide long-term visual preservation and reduce the need for frequent anti-VEGF injections. The therapy has received Fast Track designation from the FDA, PRIME designation from the EMA, and the Innovation Passport from the UK's regulatory agency. The webcast will be accessible via the company's investor relations webpage, with a replay available shortly afterward.
Potential Positives
- Adverum Biotechnologies will present pivotal 52-week LUNA phase 2 clinical data and 4-year OPTIC clinical data, potentially highlighting significant advancements in their gene therapy approach.
- The FDA has granted Fast Track designation to Adverum's gene therapy candidate Ixo-vec for the treatment of wet AMD, signifying its potential to address a serious medical need and expedite development.
- Ixo-vec has received additional designations including PRIME from the EMA and the Innovation Passport from the UK’s Medicines and Healthcare Products Regulatory Agency, enhancing its credibility and support in the regulatory process.
Potential Negatives
- The webcast is intended to report on the efficacy of Ixo-vec, suggesting that positive long-term results may not yet be fully established, which could indicate uncertainty in the therapy's success.
- The choice to hold a webcast for data reporting could imply that previous clinical data may not have met investor expectations or generated sufficient confidence, necessitating a more public discussion to gain credibility.
FAQ
When is the Adverum webcast for LUNA and OPTIC clinical data?
The Adverum webcast will be held on Monday, November 18th, at 7:30 a.m. EST.
How can I access the Adverum investor webcast?
The webcast can be accessed under Events and Presentations on the company’s investors page: https://investors.adverum.com/events-and-presentations.
What is Ixo-vec's role in treating wet AMD?
Ixo-vec is a gene therapy candidate designed for a one-time injection to treat wet AMD, reducing the need for frequent anti-VEGF injections.
What approvals has Ixo-vec received?
Ixo-vec has received Fast Track designation from the FDA, PRIME designation from the EMA, and an Innovation Passport from the UK’s MHRA.
What is the aim of Adverum Biotechnologies?
Adverum aims to establish gene therapy as the new standard of care for prevalent ocular diseases, particularly to preserve vision and prevent blindness.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
– Investor & analyst webcast, including a key opinion leader panel, to be held Monday, November 18 th at 7:30 a.m. EST
REDWOOD CITY, Calif., Nov. 15, 2024 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company pioneering the use of gene therapy to preserve sight for life in highly prevalent ocular diseases, plans to host a webcast to report 52-week LUNA phase 2 clinical data and 4-year OPTIC clinical data, and to provide key pivotal program design elements Monday, November 18th at 7:30 a.m. EST.
Webcast Details
The live webcast will be accessible under Events and Presentations in the Investors section of the company's website. Listeners can access the webcast through this link: https://investors.adverum.com/events-and-presentations . A replay will be available on the company’s website shortly after the conclusion of the webcast.
About Wet Age-Related Macular Degeneration
Wet AMD, also known as neovascular AMD or nAMD, is a VEGF driven advanced form of AMD affecting approximately 10% of patients living with AMD associated with the build-up of fluid in the macula and the retina. Wet AMD is a leading cause of blindness in people over 65 years of age, with approximately 20 million individuals worldwide living with this condition. New cases of wet AMD are 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. Additionally, wet AMD is a bilateral disease, and incidence of nAMD in the second eye is up to 42% in the first two to three years. The current standard of care requires frequent life-long repeated bolus injections of anti-VEGF in the eye. IVT gene therapy has the promise to preserve vision and reduce most or all injections for the life of the patient by delivering stable therapeutic levels of anti-VEGF to control macular fluid.
About Ixo-vec in Wet AMD
Adverum is developing ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022), its clinical-stage gene therapy product candidate, for the treatment of wet AMD. Ixo-vec utilizes a proprietary vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. Unlike other ophthalmic gene therapies that require surgery to administer the gene therapy under the retina (sub-retinal approach), Ixo-vec is designed to be administered as a one-time IVT injection in the physician’s office, deliver long-term efficacy, reduce the burden of frequent anti-VEGF, optimize patient compliance and improve vision outcomes for patients with wet AMD. In recognition of the need for new treatment options for wet AMD, FDA granted Fast Track designation for Ixo-vec for the treatment of wet AMD. Ixo-vec has also received PRIME designation from the EMA and the Innovation Passport from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency for the treatment of wet AMD.
About Adverum Biotechnologies
Adverum Biotechnologies (NASDAQ: ADVM) is a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies, designed to be delivered in physicians’ offices, to eliminate the need for frequent ocular injections to treat these diseases. Adverum is evaluating its novel gene therapy candidate, ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022), as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration. Additionally, by overcoming the challenges associated with current treatment paradigms for debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe. For more information, please visit www.adverum.com.
Inquiries:
Adverum Investor Relations
Email:
[email protected]
