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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 data from Cohorts 1-4 of the OPTIC Phase 1 clinical trial for ADVM-022, a gene therapy targeting wet age-related macular degeneration (AMD). The presentation will take place on February 13, 2021, at 9:30 am ET, showcasing the therapy's potential benefits for patients requiring frequent anti-VEGF treatments. ADVM-022 represents a significant advancement in treating AMD and diabetic macular edema, aiming for a one-time intravitreal injection solution.
Adverum Biotechnologies (Nasdaq: ADVM) announced the completion of patient enrollment in the INFINITY Phase 2 trial for ADVM-022, targeting diabetic macular edema (DME). Data is anticipated in the second half of 2021. A pivotal trial for ADVM-022 in wet age-related macular degeneration (AMD) is planned for mid-2021 after regulatory discussions. The company is also developing a new GMP manufacturing facility in North Carolina, expected to be production-ready by the end of 2023, enhancing its capacity to support clinical and commercial needs.
Adverum Biotechnologies (ADVM) is set to invest over $80 million in a new 174,000-square-foot Good Manufacturing Practices facility in Durham, NC, aimed at producing ADVM-022 for wet AMD and DME. The facility will include multiple production suites with a total capacity of 4000L and is expected to create over 200 jobs. Adverum will also receive up to $9 million in state and local incentives to support this initiative. The facility is anticipated to be production-ready by the end of 2023, underpinning Adverum's commercialization strategy for its gene therapy products.
Adverum Biotechnologies (Nasdaq: ADVM), a clinical-stage gene therapy company focusing on ocular and rare diseases, will present at the 39th Annual J.P. Morgan Healthcare Conference on January 13, 2021, at 10:50 a.m. ET. The presentation will highlight the company’s innovative gene therapy candidate, ADVM-022, aimed at treating wet age-related macular degeneration and diabetic macular edema. A live webcast of the event will be available on Adverum's website, and an archived version will be accessible for 30 days following the presentation.
Adverum Biotechnologies (Nasdaq: ADVM) announced the appointment of Dawn Svoronos to its Board of Directors. Svoronos, with 30 years in the biopharmaceutical sector, most notably at Merck, is expected to guide the commercialization of the company's gene therapy candidate ADVM-022. This therapy aims to treat ocular diseases, particularly wet AMD and diabetic macular edema. The company is preparing for a pivotal Phase 2b trial in mid-2021, highlighting its commitment to addressing significant medical needs.
Adverum Biotechnologies (Nasdaq: ADVM) announced its participation in the Piper Sandler 32nd Annual Virtual Healthcare Conference. The company focuses on addressing unmet medical needs in ocular and rare diseases. A video webcast of their presentation will be available on demand starting at 10:00 am ET today and can be accessed for 30 days on their website. Adverum is advancing its gene therapy candidate, ADVM-022, aimed at treating wet age-related macular degeneration and diabetic macular edema.
Adverum Biotechnologies announced positive interim results from the OPTIC Phase 1 trial of ADVM-022, a gene therapy for wet age-related macular degeneration (AMD). The therapy showed a substantial reduction in the need for anti-VEGF injections, with a 99% reduction in the high-dose group and 85% in the low-dose group. Patients displayed sustained efficacy and safety, with most remaining anti-VEGF injection-free. The FDA has lifted the partial clinical hold, allowing plans for pivotal trials to progress, aiming for initiation in mid-2021.
Adverum Biotechnologies reported significant progress in its clinical programs for ADVM-022 targeting wet AMD and DME. The FDA has removed a partial clinical hold, allowing the company to prepare for a pivotal trial in mid-2021. Financial results for Q3 show cash reserves of $454.5 million, bolstered by a $203.4 million public offering. However, the company reported a net loss of $27.8 million for the quarter, up from $16.1 million last year. Adverum's increased R&D expenses are attributed to growth in personnel and production costs.
Adverum Biotechnologies (Nasdaq: ADVM) announced the upcoming presentation of clinical data from its OPTIC Phase 1 trial, focusing on its ADVM-022 gene therapy for wet age-related macular degeneration (AMD). Dr. Carl Regillo will present this data on November 13, 2020, during the Retina Subspecialty Day at the AAO 2020 Virtual Meeting. A webcast featuring key opinion leaders discussing the new data will follow on November 14, 2020. The company plans to report its third-quarter financial results after the market closes on November 5, 2020.
Adverum Biotechnologies (Nasdaq: ADVM), a clinical-stage gene therapy company, will present at the Cantor Virtual Global Healthcare Conference on September 15, 2020, at 1:00 pm PT. The presentation will focus on their innovative gene therapy candidate, ADVM-022, aimed at treating wet age-related macular degeneration and diabetic macular edema. Investors can access a live webcast under the Events section on the company's website, with an archived version available for 30 days post-event.
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