Adverum Biotechnologies Inc
NASDAQ:ADVM
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Adverum Biotechnologies Inc
NASDAQ:ADVM
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Adverum Biotechnologies Inc
Adverum Biotechnologies, Inc. is a clinical-stage gene therapy company that engages in the development of gene therapies for ocular and rare diseases. The company is headquartered in Redwood City, California and currently employs 188 full-time employees. The company went IPO on 2014-07-31. The firm develops gene therapy product candidates. Its lead product candidate, ADVM-022, is a single, in-office intravitreal (IVT) injection gene therapy product designed to deliver long-term durable levels of aflibercept associated with a sustained treatment response, reducing the treatment burden and fluctuations in macular fluid associated with frequent anti-vascular endothelial growth factor (VEGF) injections. ADVM-022 is being developed for the treatment of patients with wet age-related macular degeneration (wet AMD) who are responsive to anti-VEGF therapy. The firm's second product candidate, ADVM-062 (AAV.7m8-L-opsin), is a gene therapy product candidate being developed to deliver a functional copy of the OPN1LW gene to the foveal cones of patients suffering from blue cone monochromacy (BCM) via a single IVT injection.
Adverum Biotechnologies, Inc. is a clinical-stage gene therapy company that engages in the development of gene therapies for ocular and rare diseases. The company is headquartered in Redwood City, California and currently employs 188 full-time employees. The company went IPO on 2014-07-31. The firm develops gene therapy product candidates. Its lead product candidate, ADVM-022, is a single, in-office intravitreal (IVT) injection gene therapy product designed to deliver long-term durable levels of aflibercept associated with a sustained treatment response, reducing the treatment burden and fluctuations in macular fluid associated with frequent anti-vascular endothelial growth factor (VEGF) injections. ADVM-022 is being developed for the treatment of patients with wet age-related macular degeneration (wet AMD) who are responsive to anti-VEGF therapy. The firm's second product candidate, ADVM-062 (AAV.7m8-L-opsin), is a gene therapy product candidate being developed to deliver a functional copy of the OPN1LW gene to the foveal cones of patients suffering from blue cone monochromacy (BCM) via a single IVT injection.
Regulatory Progress: Adverum secured clear FDA feedback for its ADVM-022 wet AMD program, paving the way for a targeted BLA submission in 2024.
Phase 3 Plans: Two global Phase 3 pivotal trials of ADVM-022 in wet AMD will launch in Q4, enrolling about 900 newly diagnosed patients.
Efficacy & Durability: ADVM-022 showed robust and durable results in the OPTIC study, with up to 85% reduction in annualized anti-VEGF injection frequency and two-thirds of patients injection-free for 60+ weeks.
Safety Profile: The therapy demonstrated a favorable safety profile, with minimal inflammation and manageable steroid eye drop use, especially at the 2E11 dose.
DME Progress: The INFINITY study in diabetic macular edema is fully enrolled, with primary endpoint data expected in the second half of the year.
Operational Resilience: Despite the pandemic, clinical trial enrollment continued at pace and a new GMP manufacturing facility was established.
Physician & Patient Excitement: Investigators expressed strong enthusiasm for the therapy's potential to transform care and reduce treatment burden.