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ARVO 2023: Adverum Biotechnologies presents nonclinical data supporting potential for staggered bilateral administration of Ixo-vec

Article

According to data presented at the Association for Research in Vision and Ophthalmology annual meeting in New Orleans, staggered administration of Ixo-vec in non-human primates showed peak aflibercept protein levels in the second eye within the targeted therapeutic range, supporting the potential for bilateral administration.

(Image Credit: AdobeStock)

(Image Credit: AdobeStock)

Adverum Biotechnologies Inc. today announced nonclinical data supporting the two doses of ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022) 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 (ARVO) 2023 Annual Meeting in New Orleans.

“The nonclinical data presented today support the two doses we are evaluating in the ongoing LUNA trial of Ixo-vec for the treatment of wet AMD, both in terms of tolerability and aflibercept levels within the targeted therapeutic range,” Brigit Riley, PhD, chief scientific officer at Adverum Biotechnologies, said in a statement. “Additionally, we are encouraged by the results of our nonclinical study evaluating staggered, bilateral administration as approximately 10% of patients convert from single eye to bilateral disease per year, representing an important area of unmet need that warrants clinical evaluation of Ixo-vec in bilateral wet AMD.”

Data Highlights

  • 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 (NOAEL) was identified in NHPs at the human equivalent dose of 2E11 (3 X 10^10 vg/eye dose in NHP) 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.
References:
  1. Gangnon RE, Lee KE, Klein BE, Iyengar SK, Sivakumaran TA and Klein R (2015) Severity of age-related macular degeneration in 1 eye and the incidence and progression of age-related macular degeneration in the fellow eye: the Beaver Dam Eye Study. JAMA Ophthalmol; 133 (2): 125–132.
  2. Rasmussen A., Fuchs J, Hansen LH, Larsen M, Sander B and Lund-Andersen H (2017) Neovascular age-related macular degeneration: is it worthwhile treating an eye with poor visual acuity, if the visual acuity of the fellow eye is good?. Eye 31, 978–980 (2017).
  3. Wong TY, Lanzetta P, Bandello F, Eldem B, Navarro R, Lövestam-Adrian M and Loewenstein A (2020) Current concepts and modalities for monitoring the fellow eye in neovascular age-related macular degeneration. An Expert Panel Consensus. Retina. 40, 599-611
  4. Zarranz-Ventura J, Liew G, Johnston RL, Xing W, Akerele T, McKibbin M et al. (2014). The neovascular age-related macular degeneration database: report 2: incidence, management, and visual outcomes of second treated eyes. Ophthalmology; 121 (10): 1966–1975.
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