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Overview of Adverum Biotechnologies, Inc. (NASDAQ: ADVM)
Adverum Biotechnologies, Inc. is a U.S.-based clinical-stage gene therapy company at the forefront of developing innovative treatments for serious and rare ocular diseases. Leveraging a proprietary adeno-associated virus (AAV)-based directed evolution platform, Adverum aims to provide durable efficacy through sustained expression of therapeutic proteins. The company focuses on developing gene therapies for conditions such as alpha-1 antitrypsin (A1AT) deficiency, hereditary angioedema (HAE), and wet age-related macular degeneration (wet AMD).
Core Business and Achievements:
Adverum is advancing a robust pipeline of gene therapy product candidates. Its lead candidate, ADVM-022 (also known as Ixo-vec), is an intravitreal (IVT) injection designed to deliver long-term aflibercept levels, significantly reducing the need for frequent anti-VEGF injections in patients with wet AMD. ADVM-022 is currently being evaluated in multiple clinical trials, including the Phase 2 LUNA trial, showing promising results in maintaining vision and reducing treatment burdens.
Recent Developments:
- Leadership Appointments: In 2023, Adverum appointed Dr. C. David Nicholson and Dr. Rabia Gurses Ozden to its Board of Directors, bringing extensive pharmaceutical and clinical development expertise.
- Clinical Trials: The company reported positive preliminary efficacy and safety data from the LUNA Phase 2 trial, demonstrating significant reductions in anti-VEGF injection rates and strong safety profiles.
- Financial Growth: Adverum completed a $127.5 million private placement financing, expected to fund operations into late 2025.
Key Products and Partnerships:
Adverum’s flagship product, ADVM-022, is a gene therapy candidate for wet AMD. The company collaborates with strategic partners to enhance its research and development efforts, generating revenue through licensing, research agreements, and collaborations.
With its innovative gene therapy platform and strategic initiatives, Adverum aims to transform the standard of care for ocular diseases, preserving vision and potentially offering functional cures.
Latest News:
- November 2023: Appointment of C. David Nicholson, Ph.D., to Board of Directors.
- February 2024: Presentation of preliminary LUNA Phase 2 data at the Macula Society meeting.
- March 2024: Completion of $127.5 million private placement financing.
- April 2024: Upcoming presentation of 26-week LUNA interim analysis at the ASRS Annual Scientific Meeting.
Adverum Biotechnologies (Nasdaq: ADVM) announced its first subject dosed in the Phase 2 LUNA trial for Ixo-vec, targeted at wet AMD, as it reports Q3 2022 financial results. The company highlighted promising interim data from its OPTIC trial, showing that Ixo-vec can significantly reduce injection frequency, with an 81%-98% decrease in mean annualized anti-VEGF injections. Financially, Adverum had $203.3 million in cash as of September 30, 2022, projected to fund operations into 2025. The net loss for Q3 2022 was $40.1 million, or $0.40 per share, reflecting a slight increase from the previous year.
Adverum Biotechnologies (NASDAQ: ADVM) presented promising long-term data from the OPTIC study for Ixo-vec, a gene therapy for wet age-related macular degeneration (AMD). The study showed that a single intravitreal injection of Ixo-vec reduced annualized anti-VEGF injections by 81% to 98% over two years. Notably, 80% of subjects in the higher dose group were injection-free. The therapy maintained or improved visual acuity and central thickness, with all participants in the lower dose group remaining free from inflammation at study's end. Data supports ongoing Phase 2 LUNA trial.
Adverum Biotechnologies (Nasdaq: ADVM) announced the presentation of new data from the OPTIC trial of ixoberogene soroparvovec (Ixo-vec) for wet age-related macular degeneration (wet AMD) at The Retina Society Annual Meeting on November 4, 2022. This will showcase the first end-of-study, two-year results across all four cohorts. Wet AMD, affecting around 20 million globally, is a leading cause of blindness in those over 65. The OPTIC trial evaluates ADVM-022's safety and efficacy, aiming to provide long-term results with a single intravitreal injection.
Adverum Biotechnologies (ADVM) presented new findings on its gene therapy Ixo-vec for wet AMD at the AAO 2022 meeting. A single injection resulted in a significant reduction of intraretinal (93%) and subretinal fluid (55%) after 48 weeks, highlighting the therapy's potential to decrease the need for anti-VEGF injections by 81-98%. The ongoing Phase 2 LUNA trial aims to further evaluate Ixo-vec's efficacy at different doses and steroid regimens. This innovative treatment approach could redefine care for wet AMD patients and potentially mitigate the growing incidence of this condition globally.
Adverum Biotechnologies (NASDAQ: ADVM), a clinical-stage company focused on gene therapy for ocular diseases, announced that its Chief Medical Officer, Richard Beckman, M.D., will participate in a fireside chat at the Chardan’s 6th Annual Genetic Medicines Conference on October 3, 2022, at 4:00 p.m. ET. The event will be accessible via an on-demand webcast, which will remain available for 90 days on the company’s website. Adverum aims to develop a one-time gene therapy, ixoberogene soroparvovec (Ixo-vec), to treat neovascular age-related macular degeneration, minimizing the need for frequent ocular injections.
Adverum Biotechnologies (Nasdaq: ADVM) announced that COO Peter Soparkar will present at the Jefferies Cell and Genetic Medicine Summit on September 29, 2022, at 9:30 a.m. ET. The event will focus on gene therapy innovations targeting prevalent ocular diseases, aiming to transform treatment standards and preserve vision. An on-demand webcast of the presentation will be accessible on Adverum's website for 90 days following the event. The company is developing a one-time gene therapy injection, Ixo-vec, for treating wet age-related macular degeneration.
Adverum Biotechnologies (Nasdaq: ADVM) has announced that data from the OPTIC trial of ixoberogene soroparvovec (Ixo-vec) in wet age-related macular degeneration (wet AMD) will be presented on September 30, 2022, during the American Academy of Ophthalmology 2022 Annual Meeting in Chicago. The presentation will cover the efficacy and safety data up to 104 weeks and include analyses of intraretinal fluid and subretinal fluid after a single IVT injection. Wet AMD affects about 20 million individuals globally and leads to blindness in patients over 65 years.
Adverum Biotechnologies announced dosing of the first subject in the LUNA Phase 2 trial for ixoberogene soroparvovec (Ixo-vec) targeting wet age-related macular degeneration (wet AMD). The trial examines two dosing levels: 2E11 vg/eye and a new lower dose of 6E10 vg/eye. Primary endpoints include best corrected visual acuity (BCVA) change over one year and adverse event incidence. Initial data, including aflibercept expression at Week 10, is expected in 2023. This trial could enhance treatment for wet AMD patients and potentially reduce the need for frequent anti-VEGF injections.
Adverum Biotechnologies (Nasdaq: ADVM) announced that CEO Laurent Fischer, M.D., will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 12, 2022. The event will focus on the company's gene therapy efforts aimed at treating prevalent ocular diseases through its proprietary intravitreal platform. Adverum's lead candidate, ixoberogene soroparvovec (Ixo-vec), is being developed as a one-time injection for wet age-related macular degeneration. An on-demand webcast of the presentation will be available on Adverum's website for 90 days.
Adverum Biotechnologies (NASDAQ: ADVM), a clinical-stage company focused on gene therapy for ocular diseases, announced that its CEO, Laurent Fischer, M.D., will present at the Gilmartin Group Emerging Growth Company Showcase on August 31, 2022. The live presentation will be accessible online, and a recorded version will follow. Adverum is working on innovative, long-lasting gene therapy treatments, like ixoberogene soroparvovec, aimed at offering a single injection solution for conditions such as wet age-related macular degeneration, striving to change the standard of care and enhance vision preservation.
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