IVERIC bio and Catalent Biologics announced they have entered into an agreement for production and manufacturing of GMP-grade adeno-associated virus (AAV) vector for IVERIC bio’s gene therapy product candidates, IC-100 for the treatment of rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP) and IC-200 for the treatment of BEST1 related retinal diseases. IVERIC bio expects to initiate Phase 1/2 clinical trials for IC-100 in 2020 and IC-200 in the first half of 2021. IVERIC bio has engaged Paragon Gene Therapy, part of Catalent Biologics, to provide materials for preclinical activities and its planned Phase 1/2 clinical trials for both product candidates.
“We fully appreciate the importance of having a world-class manufacturing infrastructure in place as we continue to build and advance our gene therapy pipeline for inherited retinal diseases,” said Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. “Our relationship with Catalent secures access to state-of-the-art manufacturing capabilities and capacity that we believe will enable us to enter into the next phase of gene therapy development with our product candidates IC-100 for RHO-adRP and IC-200 for BEST1 related retinal diseases.”
“We are extremely pleased to partner with IVERIC bio as they advance their portfolio of AAV gene therapies for orphan inherited retinal diseases,” said Pete Buzy, President of Paragon Gene Therapy. “We look forward to a strong relationship with the goal of achieving IVERIC bio’s gene therapy AAV manufacturing milestones for the production of clinical material.”
“We believe that AAV gene therapy is the future of drug development for orphan inherited retinal diseases,” said Keith Westby, Chief Operating Officer of IVERIC bio. “When building a gene therapy franchise the selection of an experienced manufacturer is a critical component. We believe Paragon’s specialized expertise in AAV vector manufacturing and the addition of their new world-class commercial-scale facility will positively impact the advancement of our gene therapy pipeline. We look forward to collaborating closely with the Paragon team.”