OPTIC | Jotup

Adverum Biotechnologies Presents Three-Year Aflibercept Protein Expression and Improvement in Anatomic Outcomes After a Single IVT Injection of ADVM-022 in the OPTIC Study in Wet AMD

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четверг, июня 9, 2022

GLOBE, Patient, Adverum Biotechnologies, Nasdaq, Pharmaceutical industry, Vaccine, OPTIC

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.

Adverum Biotechnologies Announces New Data at the Macula Society’s 2022 Annual Meeting

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четверг, июня 2, 2022

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.

Adverum Presents Data at ASGCT Further Supporting Phase 2 Development Plans for ADVM-022

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вторник, мая 17, 2022

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.

Adverum Biotechnologies Reports First Quarter 2022 Financial Results

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четверг, мая 12, 2022

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.

Adverum Biotechnologies Announces Upcoming Data Presentations at ASGCT 2022

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понедельник, мая 2, 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 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.

Adverum Biotechnologies Presents Additional Efficacy and Safety Data from the OPTIC Trial of ADVM-022 in Wet AMD at the ARVO 2022 Annual Meeting

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воскресенье, мая 1, 2022

Injection, Adverum Biotechnologies, OPTIC, Association, Nasdaq, AAV, GLOBE, Research, Annual general meeting, Lance, Association for Research in Vision and Ophthalmology, IVT, VEGF, ARVO, Safety, Pharmaceutical industry, Vaccine, 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.

Adverum Biotechnologies Announces Upcoming Data Presentations at ARVO 2022

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вторник, апреля 19, 2022

Adverum Biotechnologies, OPTIC, Safety, Association for Research in Vision and Ophthalmology, Association, Nasdaq, Lance, ARVO, GLOBE, Annual general meeting, Research, Pharmaceutical industry, Ophthalmology

New analyses to be presented at ARVO assessed the impact of baseline levels of neutralizing antibodies (NAbs) to AAV.7m8 on ADVM-022 efficacy and safety outcomes.

Key Points:

New analyses to be presented at ARVO assessed the impact of baseline levels of neutralizing antibodies (NAbs) to AAV.7m8 on ADVM-022 efficacy and safety outcomes.
67% (10/15) of the subjects dosed with ADVM-022 at the 2E11 dose had baseline NAbs titers of
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.

Adverum Biotechnologies Reports Fourth Quarter and Full Year 2021 Financial Results

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вторник, марта 29, 2022

The company expects to dose the first patient in the Phase 2 trial in the third quarter of 2022.

Key Points:

The company expects to dose the first patient in the Phase 2 trial in the third quarter of 2022.
Stock-based compensation expense included in research and development expenses was $1.8 million for the fourth quarter of 2021.
Stock-based compensation expense included in general and administrative expenses was $2.7million for the fourth quarter of 2021.
Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases.

Horizon Therapeutics plc Initiates Phase 3 Clinical Trial (OPTIC-J) in Japan Evaluating Teprotumumab for the Treatment of Active Thyroid Eye Disease (TED)

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среда, февраля 23, 2022

Biotechnology, Health, Pharmaceutical, Optical, Clinical Trials, Cell, Hair, Autoimmunity, Randomness, Autoantibody, COVID-19, Teprotumumab, Health, OPTIC, Trial of the century, Nasdaq, Research, Incidence, Headache, Lists of World Heritage Sites, Courage, SEC, Inflammation, Diarrhea, Medicines and Healthcare products Regulatory Agency, Graves' ophthalmopathy, Nausea, Safety, Disease, PMDA, Treatment, Food, Priority review, Fatigue, European Group, TED, Clinical, Huber loss, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Twitter, Week, Spasm, Family, Severe cognitive impairment, Menstrual disorder, Swelling, LinkedIn, CAS, Sleep, Instagram, Patient, Red, Exophthalmos, Medicine, Clinical trial, Mab, Science, FDA, Diplopia, Hyperglycemia, Cover My Eyes (Pain and Heaven), Fibroblast, Pharmaceutical industry, Silviculture, Facebook, Dysgeusia, Thyroid Eye Disease (TED), Teprotumumab, Horizon, THYROID EYE DISEASE (TED), TEPROTUMUMAB, HORIZON

Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the first patient has been enrolled in a Phase 3 clinical trial (OPTIC-J) in Japan evaluating teprotumumab for the treatment of active TED.

Key Points:

Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the first patient has been enrolled in a Phase 3 clinical trial (OPTIC-J) in Japan evaluating teprotumumab for the treatment of active TED.
This dosage and administration are based on approval in the United States and may not be the same if approved in Japan.
OPTIC-J is an acronym for Treatment of Graves Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis with Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study Japan.
More information about the trial, including eligibility criteria, is available on the Japan Registry of Clinical Trials website (trial ID number jRCT2031210453 ).

Adverum Biotechnologies Provides ADVM-022 Development Update and Anticipated Corporate Milestones for 2022

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вторник, декабря 21, 2021

REDWOOD CITY, Calif., Dec. 21, 2021 (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 completion of a review of its ADVM-022 program, outlined plans for the next stage of development in wet age-related macular degeneration (wet AMD) and provided anticipated key milestones for 2022.

Key Points:

The trial is expected to enroll approximately 72 patients and evaluate similar endpoints to the Phase1 OPTIC trial in wet AMD.
Adverum reiterates its expectation that its cash position is sufficient to fund the companys operations, including its development plans for ADVM-022, into 2024.
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.