Adverum Biotechnologies presents nonclinical data at 2023 ARVO meeting

Adverum Biotechnologies announced nonclinical data supporting the two doses of ixoberogene soroparvovec being evaluated in the Phase 2 LUNA trial and the potential for staggered, bilateral administration in the treatment of wet AMD. The data were featured in an oral presentation at the Association for Research in Vision and Ophthalmology 2023 Annual Meeting in New Orleans, Louisiana. Staggered, bilateral administration of Ixo-vec in NHPs was well tolerated with encouraging therapeutic activity and no signals of increased inflammation. A no-observed-adverse-effect level was identified in NHPs at the human equivalent dose of 2E11 supporting the human 2E11 and 6E10 doses in the ongoing Phase 2 LUNA study in wet AMD. Both 2E11 and 6E10 human equivalent doses resulted in therapeutic aflibercept levels with mean peak levels comparable with those observed in previous NHP and in human studies utilizing higher doses of Ixo-vec. Administration of a single intravitreal dose of Ixo-vec in the second eye resulted in peak aflibercept levels that are within the targeted therapeutic range. Despite elevated systemic humoral response after first eye injection, second eye total antibodies were undetectable prior to injection of Ixo-vec dose in the second eye.