Associated tags: Adverum Biotechnologies, Standard of care, Paratriathlon, Patient, IVT, Research, Neovascularization, Biotechnology, Pharmaceutical industry, AMD, Safety, OPTIC
Locations: UNITED STATES, EUROPE, GERMANY, BELGIUM, UK, ET, TD, REDWOOD CITY, CA, US, SWEDEN
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Adverum Biotechnologies REDWOOD CITY, Calif., July 08, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced that new data from the Phase 1 OPTIC study of ADVM-022 (AAV.7m8-aflibercept) development program in wet age-related macular degeneration (wet AMD) will be presented next week during the American Society of Retina Specialists (ASRS) 2022 Annual Meeting in New York City. The presentation will include new best-corrected visual acuity (BCVA) results, as well as the previously reported aflibercept protein expression data through three years post-treatment with ADVM-022 (ixoberogene soroparvovec).
Key Points:
- The presentation will include new best-corrected visual acuity (BCVA) results, as well as the previously reported aflibercept protein expression data through three years post-treatment with ADVM-022 (ixoberogene soroparvovec).
- Wet AMD, also known as neovascular AMD or nAMD, is an advanced form of AMD, affecting approximately 10% of patients living with AMD.
- AMD is projected to impact 288 million people worldwide by 2040, with wet AMD accounting for approximately 10% of those cases.
- 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.
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Adverum Biotechnologies REDWOOD CITY, Calif., July 06, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced that it has completed its Investigational New Drug (IND) amendment with the U.S. Food and Drug Administration (FDA) and is preparing to initiate the Phase 2 LUNA trial of ADVM-022, a single intravitreal (IVT) injection for wet age-related macular degeneration (wet AMD). The World Health Organization’s Review Council and the U.S. Adopted Names Council has adopted the name ixoberogene soroparvovec (Ixo-vec) for ADVM-022 as the international nonproprietary name.
Key Points:
- We amended our IND and are on track to dose the first patient in the Phase 2 LUNA trial for the treatment of wet AMD in the coming months.
- We are excited to initiate our Phase 2 LUNA trial this quarter.
- The LUNA trial is a multicenter, double-masked, randomized, parallel-group Phase 2 trial evaluating two doses of Ixo-vec, including the 2x10^11 vg/eye dose and a new, lower 6x10^10 vg/eye dose, in wet AMD.
- Wet AMD, also known as neovascular AMD or nAMD, is an advanced form of AMD, affecting approximately 10% of patients living with AMD.
REDWOOD CITY, Calif., June 09, 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 OPTIC study treating wet age-related macular degeneration (wet AMD) during the Macula Society Annual Meeting in Berlin, Germany. New analyses presented include three-year aflibercept protein expression and improved anatomical outcomes in subjects treated with ADVM-022.
Key Points:
- New analyses presented include three-year aflibercept protein expression and improved anatomical outcomes in subjects treated with ADVM-022.
- In OPTIC, over 80% of screened patients had neutralizing antibody titers
- ADVM-022 provided continuous and consistent therapeutic aflibercept expression levels through three years following a single ADVM-022 injection.
- Wet AMD, also known as neovascular AMD or nAMD, is an advanced form of AMD, affecting approximately 10% of patients living with AMD.
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Adverum Biotechnologies 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.
Key Points:
- The presentation will include an update on aflibercept protein expression data through three years post-treatment.
- Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases.
- 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.
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Adverum Biotechnologies REDWOOD CITY, Calif., May 19, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today will announce new research pipeline data supporting the utility of its proprietary adeno-associated virus (AAV) vector platform in ocular gene therapy.
Key Points:
- REDWOOD CITY, Calif., May 19, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today will announce new research pipeline data supporting the utility of its proprietary adeno-associated virus (AAV) vector platform in ocular gene therapy.
- Adverum is an industry leader in the development of adeno-associated virus ocular gene therapy, including cassette engineering and vectorizing therapeutic proteins, and we are pleased to have multiple presentations highlighting our platform at ASGCT.
- Finally, we are maturing a portfolio of proprietary vectors with specific ocular cell tropism and are excited to showcase our innovative work on LSV1, a novel capsid for ocular gene therapy.
- Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases.
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Ophthalmology REDWOOD CITY, Calif., May 17, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today will announce new data from the ADVM-022 development program in wet age-related macular degeneration (wet AMD). The data being presented during the American Society of Gene and Cell Therapy (ASGCT) 2022 Annual Meeting in Washington, D.C. and virtually, shows results of the non-human primate (NHP) studies that provide support for the new 6 X 10^10 vg/eye (6E10) dose that Adverum intends to include in its next clinical trial.
Key Points:
- The human equivalent dose of 6E10 (3 X 10^10 vg/eye dose in NHP) demonstrated potential therapeutic levels in both aqueous humor and vitreous humor.
- Administration of the human equivalent dose of 6E10 (3 X 10^10 vg/eye dose in NHP) was well tolerated.
- Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases.
- 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.
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Adverum Biotechnologies REDWOOD CITY, Calif., May 12, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today reported financial results for the first quarter ended March 31, 2022.
Key Points:
- REDWOOD CITY, Calif., May 12, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today reported financial results for the first quarter ended March 31, 2022.
- We remain on track to dose the first patient in our planned Phase 2 trial of ADVM-022 in wet age-related macular degeneration in the third quarter of 2022, stated Laurent Fischer, M.D., president and chief executive officer at Adverum Biotechnologies.
- At the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting, Adverum presented additional efficacy and safety data from the OPTIC trial of ADVM-022 in wet AMD.
- Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases.
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Adverum Biotechnologies The option has a per share exercise price equal to the closing sales price of Adverums common stock on the Nasdaq Stock Market on the grant date, and will vest over four years, subject to the employees continued service with Adverum.
Key Points:
- The option has a per share exercise price equal to the closing sales price of Adverums common stock on the Nasdaq Stock Market on the grant date, and will vest over four years, subject to the employees continued service with Adverum.
- 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.
- 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.
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Adverum Biotechnologies 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 Points:
- 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.
- 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.
- Additionally, Adverum will present data on a novel capsid, LSV1 and two posters supporting Adverums adeno-associated virus (AAV) advanced manufacturing process development platform.
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Ophthalmology REDWOOD CITY, Calif., May 01, 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 the presentation of new post-hoc analysis from the OPTIC study of ADVM-022 in wet age-related macular degeneration (wet AMD) during The Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting in Denver, Colorado and virtually.
Key Points:
- The new data from OPTIC assessed the potential impact of baseline levels of neutralizing antibodies (NAbs) on efficacy and safety outcomes with ADVM-022 (AAV.7m8-aflibercept).
- AMD is expected to impact 288 million people worldwide by 2040, with wet AMD accounting for approximately 10% of those cases.
- 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.
