Adverum Biotechnologies is cutting 78 jobs after announcing it had successfully amended its Investigational New Drug application for ADVM-022.to treat wet age-related macular degeneration.
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Adverum Biotechnologies announced Thursday that it is removing 78 jobs, slashing its workforce by 38%. This move is in line with the company’s plan to streamline operations in order to completely fund existing eye disease projects and extend its cash runway into 2025.
Adverum plans to finish restructuring by the end of the year.
By leveraging its proprietary intravitreal platform, the California-based clinical-stage company is aiming to make gene therapies a clinical standard for ocular diseases. Its leading candidate, ADVM-022 (ixoberogene soroparvovec [Ixo-vec]), is designed to treat wet age-related macular degeneration (AMD) through a one-time injection to the eye.
Wednesday, Adverum announced that it had successfully amended its Investigational New Drug application for ADVM-022 to the U.S. Food and Drug Administration. Two weeks prior, the European Medicines Agency also gave the drug candidate its Priority Medicines nod. Adverum now plans to push ADVM-022 into the Phase II study LUNA, for which it will use the savings generated from the job cuts and overall company restructuring.
“We amended our IND and are on track to dose the first patient in the Phase II LUNA trial for the treatment of wet AMD in the coming months,” Laurent Fischer, M.D., president and CEO of Adverum, said in a statement. “Additionally, we have taken measures to restructure our operations, including reductions in both headcount and expenses to prioritize Ixo-vec’s clinical development, and focus our pipeline strategy on highly prevalent ocular diseases.”
Afflicting some 20 million people worldwide, wet AMD, also called neovascular AMD, is an advanced form of the disease. In patients older than 65 years, wet AMD is a leading cause of blindness. LUNA, a multicenter, double-masked, randomized and parallel-group trial, aims to enroll more than 70 wet AMD patients and deliver two ADVM-022 doses and four prophylactic steroids. The trial will be held across 40 sites in the U.S. and Europe.
With ADVM-022, Adverum joins industry behemoths in the wet AMD space. Genentech owns the two drugs —Lucentis (ranibizumab) and Avastin (Avastin (bevacizumab)—that reign as the most commonly used treatments against the disease. Close behind are Regeneron’s Eylea (aflibercept) and Novartis’ Beovu (brolucizumab). All four are generally regarded as safe and effective, making competition stiff for Adverum.
ADVM-022 hopes to set itself apart by offering the only injectable gene therapy for wet AMD. By using a proprietary vector capsid carrier, Adverum’s candidate delivers a stretch of genetic material that, when activated, encodes for aflibercept. ADVM-022 also contains a proprietary expression cassette that controls protein expression.
Unlike the top treatments for wet AMD, which are delivered through regular eye injections, ADVM-022 is a one-time intravitreal shot, making it a much more acceptable option for patients. Adverum’s injection also differentiates itself from other ophthalmic gene therapies, which normally require eye surgeries.
ADVM-022 was initially tested as a treatment for both wet AMD and diabetic macular edema (DME). But last year, DME patients treated with high doses of the candidate experienced worrying side effects, such as inflammation and loss of vision, prompting Adverum to revise its clinical plan and focus all of its efforts on wet AMD instead. So far, no such serious safety concerns have been reported in this patient population.
