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
Ministry of National Health Services, Regulation and Coordination,
Adverum Biotechnologies,
Doctor of Pharmacy,
Anti-VEGF,
National Health Service,
AMD,
OPTIC,
Eye,
LUNA,
PRIME,
EMA,
Patient,
United Kingdom,
European Medicines Agency,
United,
National Institute for Health and Care Excellence,
Medicines and Healthcare products Regulatory Agency,
Innovation,
NHS,
FDA,
Regulation of tobacco by the U.S. Food and Drug Administration,
Safety,
Fast track (FDA),
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MHRA,
Pharmaceutical industry REDWOOD CITY, Calif., April 18, 2023 (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 the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Ixo-vec (ixoberogene soroparvovec), an investigational gene therapy for the treatment of wet AMD, an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP). The Innovation Passport is the first step in the ILAP process, triggering the MHRA and its partner agencies, including the National Institute for Health and Care Excellence (NICE) and the National Health Service (NHS) England, to partner with Adverum to charter a roadmap for regulatory and development milestones with the goal of early patient access in the United Kingdom (U.K.)
Key Points:
- The OPTIC data indicates a greater than 80% reduction in annualized anti-VEGF injections with more than 50% of the trial subjects being supplemental injection-free at two years post-treatment with Ixo-vec, which data is suggestive of a functional cure,” commented Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies.
- “The current standard of care in wet AMD, requires frequent anti-VEGF injections in the eye that can be a lifelong burden for many patients and their caregivers.
- We believe Ixo-vec has the potential to provide an in-office treatment option that is durable and safe, provides cost-savings, and addresses the needs of wet AMD patients and their families, retina specialists and health systems worldwide.
- We look forward to leveraging the benefits of ILAP designation, as we continue our development of Ixo-vec.”
“The ILAP designation grants us enhanced regulatory and market access interactions and a potentially faster path towards approval in the U.K. Ixo-vec has already received Fast Track Designation by the FDA and PRIME designation by the EMA,” said Star Seyedkazemi, PharmD, chief development officer of Adverum Biotechnologies.
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понедельник, апреля 17, 2023
REDWOOD CITY, Calif., April 17, 2023 (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 the company will present an abstract featuring nonclinical data of Ixoberogene soroparvovec (Ixo-vec) for the treatment of neovascular age-related macular degeneration at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting.
Key Points:
- REDWOOD CITY, Calif., April 17, 2023 (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 the company will present an abstract featuring nonclinical data of Ixoberogene soroparvovec (Ixo-vec) for the treatment of neovascular age-related macular degeneration at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting.
- Adverum will present data on the human equivalent dose of 6x10^10 (6E10) vg/eye that is being evaluated in Adverum’s Phase 2 LUNA study of Ixo-vec.
- In addition, data will be presented outlining aflibercept protein levels, as well as durability and tolerability following staggered bilateral administration of Ixo-vec.
- Presentation Title: Ixoberogene soroparvovec (Ixo-vec) for the treatment of neovascular age-related macular degeneration: Nonclinical data in support of human equivalent dose of 6E10 vg/eye and staggered bilateral dosing
Maintenance,
Adverum Biotechnologies,
Anti-VEGF,
AMD,
Clinical trial,
Research,
LUNA,
Inflammation,
Dexamethasone,
IVT,
Investment,
Risk,
CST,
M.A,
R,
Three Months,
Safety,
Pharmaceutical industry,
Cryptocurrency,
OPTIC REDWOOD CITY, Calif., March 30, 2023 (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 reported financial results for the fourth quarter and full year ended December 31, 2022 and provided an update on its ongoing Phase 2 LUNA trial evaluating ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022) for the treatment of wet age-related macular degeneration (wet AMD).
Key Points:
- I am excited to have enrolled my first subject in the Phase 2 LUNA trial.
- The Phase 2 LUNA trial evaluating Ixo-vec in subjects with wet AMD continues to enroll.
- Stock-based compensation expense included in research and development expenses was $1.9 million for the fourth quarter of 2022.
- Stock-based compensation expense included in general and administrative expenses was $3.3 million for the fourth quarter of 2022.
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понедельник, февраля 27, 2023
REDWOOD CITY, Calif., Feb. 27, 2023 (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 Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies, will present at the following upcoming investor conferences:
Key Points:
- REDWOOD CITY, Calif., Feb. 27, 2023 (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 Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies, will present at the following upcoming investor conferences:
Cowen 43rd Annual Health Care Conference on Wednesday, March 8, 2023 at 12:50 p.m.
- ET
Oppenheimer 33rd Virtual Annual Healthcare Conference on Wednesday, March 15, 2023 at 2:00 p.m.
- ET
The on-demand webcast corporate presentation may be accessed under Events and Presentations in the Investors section of Adverum’s website.
- A replay of the webcast will be available on the website for 90 days following the presentation.
REDWOOD CITY, Calif., Jan. 18, 2023 (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, announced a grant of stock options to a new employee.
Key Points:
- REDWOOD CITY, Calif., Jan. 18, 2023 (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, announced a grant of stock options to a new employee.
- On January 17, 2023, Adverum granted a new employee a stock option to purchase 150,000 shares of Adverum’s common stock pursuant to the inducement grant exception under Nasdaq Rule 5635(c)(4), as an inducement that is material to the employee entering into employment with Adverum.
- The option has a per share exercise price equal to the closing sales price of Adverum’s common stock on the Nasdaq Stock Market on the grant date, and will vest over four years, subject to the employee’s continued service with Adverum.
REDWOOD CITY, Calif., Dec. 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, announced a grant of stock options to a new employee.
Key Points:
- REDWOOD CITY, Calif., Dec. 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, announced a grant of stock options to a new employee.
- On December 1, 2022, Adverum granted a new employee a stock option to purchase 200,000 shares of Adverum’s common stock pursuant to the inducement grant exception under Nasdaq Rule 5635(c)(4), as an inducement that is material to the employee entering into employment with Adverum.
- The option has a per share exercise price equal to the closing sales price of Adverum’s common stock on the Nasdaq Stock Market on the grant date, and will vest over four years, subject to the employee’s continued service with Adverum.
- 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.
Quality of life,
GLOBE,
Private Securities Litigation Reform Act,
NAMD,
Prevalence,
Investment,
Gene therapy of the human retina,
Annual general meeting,
Food,
Nasdaq,
Research,
Society,
Incidence,
Injection,
Technology,
IRF,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
Neovascularization,
Severe cognitive impairment,
SEC,
NASDAQ,
American Academy,
Patient,
AMD,
Macular degeneration,
Safety,
Compliance,
U.S. Securities and Exchange Commission,
Caregiver,
OPTIC,
VEGF,
Home After Three Months Away,
Retina,
Standard of care,
European Medicines Agency,
Drug discovery,
SRF,
IVT,
Pharmaceutical industry,
Birth control,
Vaccine,
Adverum Biotechnologies REDWOOD CITY, Calif., Nov. 10, 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 financial results for the third quarter ended September 30, 2022.
Key Points:
- In July 2022, Adverum completed an Investigational New Drug amendment with the U.S. Food and Drug Administration to advance a Phase 2 trial of Ixo-vec in wet AMD.
- Stock-based compensation expense included in research and development expenses was $1.4 million for the third quarter of 2022.
- Stock-based compensation expense included in general and administrative expenses was $3.1 million for the third quarter of 2022.
- Additional risks and uncertainties facing Adverum are set forth under the caption Risk Factors and elsewhere in Adverums Securities and Exchange Commission (SEC) filings and reports, including Adverums Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 filed with the SEC on August 11, 2022.
Patient,
Severe cognitive impairment,
Gene therapy of the human retina,
VEGF,
AMD,
Private Securities Litigation Reform Act,
Research,
Compliance,
Maintenance,
CST,
IVT,
GLOBE,
Steroid,
Safety,
Incidence,
OPTIC,
Retina,
NAMD,
Macular degeneration,
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Standard of care,
Physician,
U.S. Securities and Exchange Commission,
NASDAQ,
Prevalence,
Injection,
Inflammation,
Wills Eye Hospital,
Technology,
SEC,
Neovascularization,
Birth control,
Pharmaceutical industry,
Vaccine,
Adverum Biotechnologies REDWOOD CITY, Calif., Nov. 04, 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 long-term follow-up data from the OPTIC study treating wet age-related macular degeneration (wet AMD) during The Retina Society Annual Meeting in Pasadena, California. New data presented include final two-year safety and efficacy assessment of Ixo-vec (ixoberogene soroparvovec, formerly referred to as ADVM-022), including reduction in annualized anti-VEGF injections, clinically relevant aflibercept protein levels and maintenance to improvement of mean best-corrected visual acuity (BCVA) and central subfield thickness (CST). OPTIC study participants could enroll in an extension study for an additional three years for a total of five years of follow-up.
Key Points:
- OPTIC study participants could enroll in an extension study for an additional three years for a total of five years of follow-up.
- We are pleased to present our final two-year analysis from our OPTIC trial of Ixo-vec for the treatment of wet AMD.
- All 2E11 participants were inflammation free and did not require steroids to treat inflammation at the end of the study.
- 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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четверг, октября 27, 2022
NASDAQ,
Prevalence,
Publication,
Safety,
Nasdaq,
Patient,
Macular degeneration,
OPTIC,
Neovascularization,
Compliance,
NAMD,
Retina,
Severe cognitive impairment,
Research,
GLOBE,
Standard of care,
IVT,
Incidence,
AMD,
Pharmaceutical industry,
Vaccine,
Adverum Biotechnologies Wet AMD, also known as neovascular AMD or nAMD, is an advanced form of AMD, affecting approximately 10% of patients living with AMD.
Key Points:
- Wet AMD, also known as neovascular AMD or nAMD, is an advanced form of AMD, affecting approximately 10% of patients living with AMD.
- The incidence of new cases of wet AMD is expected to grow significantly worldwide as populations age.
- AMD is projected to impact 288 million people worldwide by 2040, with wet AMD accounting for approximately 10% of those cases.
- ADVM-022, ixoberogene soroparvovec (Ixo-vec), is Adverums clinical-stage gene therapy product candidate being developed for the treatment of wet AMD.
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пятница, сентября 30, 2022
American Academy,
Retina,
Inflammation,
AAO,
Time,
Injection,
Incidence,
IRF,
Prevalence,
European Medicines Agency,
Neovascularization,
Association,
Week,
Annual general meeting,
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IVT,
Private Securities Litigation Reform Act,
Late,
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VEGF,
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SRF,
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Visual acuity,
Standard of care,
Severe cognitive impairment,
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Â,
Research,
AMD,
GLOBE,
Dexamethasone,
SEC,
American Academy of Ophthalmology,
Macular degeneration,
Pharmaceutical industry,
Medical imaging,
OPTIC,
Adverum Biotechnologies REDWOOD CITY, Calif., Sept. 30, 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 new analyses from the OPTIC study treating wet age-related macular degeneration (wet AMD) during the Late Breaking Developments portion of Retinal Subspecialty Day at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting in Chicago, Illinois. New data presented include the effects of ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022) on control of IRF and SRF after a single, in-office, intravitreal (IVT) injection in subjects requiring frequent anti-VEGF injections for their wet AMD.
Key Points:
- Following a single IVT injection of a 2E11 dose of Ixo-vec in OPTIC (n=15), there was a 93% and 55% reduction in mean IRF and SRF volume, respectively, from baseline to Week 48.
- Importantly, 60% of OPTIC participants receiving the 2E11 dose had dry IRF at Week 48, representing a 50% increase from baseline.
- 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 expected to impact 288 million people worldwide by 2040, with wet AMD accounting for approximately 10% of those cases.
