20-year biopharma industry veteran to lead manufacturing for Opus’ AAV-based gene therapies for inherited retinal diseases
RALEIGH, N.C., Feb. 15, 2022 (GLOBE NEWSWIRE) — Opus Genetics, a patient-focused gene therapy company developing treatments for orphan inherited retinal diseases, today announced the appointment of Brian Leising as Vice President of Manufacturing.
Mr. Leising has over 20 years of gene therapy, vaccine and biopharmaceutical experience in manufacturing, quality, facility startup and process development roles across a variety of products in both the clinical and commercial stages. In his role, Mr. Leising will lead Opus’ efforts with key partners to manufacture IND-enabling GLP toxicology and first-in-human material to support the continued advancement of Opus’ portfolio toward clinical trials to address orphan inherited retinal diseases. Opus anticipates filing an IND and entering first-in-human trials with lead program OPGx-001 in LCA5 this year.
“Opus is building an engine to solve as many degenerative retinal diseases as possible, and manufacturing is a lynchpin of our success in efficiently advancing new therapies for rare inherited retinal diseases into the clinic,” said Ben Yerxa, Ph.D., CEO of the Foundation Fighting Blindness and the Retinal Degeneration Fund, and acting CEO of Opus. “Brian will be instrumental in the conceptualization and development of our manufacturing approach and we’re glad to have him on board as we work toward IND and our first-in-human trials later this year.”
Mr. Leising previously served as Director of Manufacturing Quality at Novartis Gene Therapies (formerly AveXis). In this role, he was responsible for implementation and oversight of the site quality systems for AAV gene therapy for the Durham facility startup, validation and licensure for Zolgensma, as well as for multiple clinical molecules. Prior to Novartis Gene Therapies, Mr. Leising was Director of Clinical Gene Therapy Manufacturing at Pfizer’s former Bamboo facility overseeing Phase 1 manufacturing of their AAV-based gene therapies and future clinical manufacturing infrastructure. Mr. Leising holds an M.S. in biotechnology from the University of Maryland and a B.S. in biology from the Florida Institute of Technology.
“Opus has an incredible opportunity to move strong and validated science and well-characterized material into the clinic expeditiously,” said Mr. Leising. “I’m thrilled to join Opus to help drive the development of a scalable, strategic manufacturing infrastructure that can be leveraged for IND, clinical and commercial stages, for multiple products.”
About Opus Genetics
Opus Genetics is a groundbreaking gene therapy company for inherited retinal diseases with a unique model and purpose. Backed by Foundation Fighting Blindness’s venture arm, the RD Fund, Opus combines unparalleled insight and commitment to patient need with wholly owned programs in numerous orphan retinal diseases. Its AAV-based gene therapy portfolio tackles some of the most neglected forms of inherited blindness while creating novel orphan manufacturing scale and efficiencies. Based in Raleigh, N.C., the company leverages knowledge of the best science and the expertise of pioneers in ocular gene therapy to transparently drive transformative treatments to patients. For more information, visit www.opusgenetics.com.