Adverum lays off 38% of staff as it enters new trial for ocular gene therapy after last year's safety woes
Adverum is moving forward with its eye disease gene therapy that caused headaches in April 2021, but is doing so with fewer staff on board.
The biotech is laying off 78 employees, or about 38% of its workforce, in order to conserve cash and keep the lights on into 2025, according to an SEC filing.
The Redwood City, CA, biotech said Wednesday it has amended the IND for a Phase II study of its gene therapy in wet age-related macular degeneration (AMD). The trial of ADVM-022 will kick off this quarter, CMO Richard Beckman said in a statement.
Adverum’s stock $ADVM rose nearly 9% after the opening bell Thursday. The restructuring will eliminate about $15.3 million annually in “direct labor cost,” according to the biotech’s SEC filing.
Now dubbed ixoberogene soroparvovec (Ixo-vec), an earlier trial of the gene therapy led to a loss of vision in one patient’s treated eye last year. That patient had diabetic macular edema and received a higher dose of the gene therapy.
The safety issues from the high dose ended up affecting five of 12 patients with diabetic macular edema in that Phase II trial, the company said last July. It is now moving forward with a lower dose and is only testing the gene therapy in patients with wet AMD in the Phase II LUNA trial.
“We designed the LUNA trial after a thorough review of data generated in all 55 study participants treated to date with a single injection of ADVM-022, some of whom have now demonstrated continuous and stable aflibercept expression for over three years. We have deepened our understanding of adeno-associated virus (AAV) mediated ocular gene therapy, including the inflammatory response to AAV, and this is informing our strategy to mitigate immunogenicity,” Beckman, the medical chief, said in a statement.
CEO Laurent Fischer said the company has worked on its manufacturing strategy to have a “scalable approach designed to provide an ample supply of Ixo-vec to support our clinical development program through biologics license application filing.”
With the layoffs and refined focus on ADVM-022, Adverum has enough cash to fund itself beyond one-year topline results from the 72-patient LUNA trial, Fischer said in a statement. The biotech had $271.1 million in cash as of March 31.