RALEIGH, North Carolina, Feb. 10, 2022 (GLOBE NEWSWIRE) — Opus Genetics, a patient-focused gene therapy company developing treatments for inherited orphan 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, plant start-up and process development roles for a variety of clinical and commercial stage products. In his role, Mr. Leising will lead Opus’ efforts with key partners to manufacture IND-enabling GLP toxicology and early human material to support the continued advancement of Opus’ portfolio toward clinical trials to treat diseases. orphan hereditary retinals. Opus plans to file an IND and enter first-in-human trials with the OPGx-001 lead program in LCA5 this year.
“Opus is building an engine to solve as many degenerative retinal diseases as possible, and manufacturing is the keystone of our success in effectively 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 interim CEO of Opus. “Brian will be instrumental in the conceptualization and development of our manufacturing approach and we are pleased to have him by our side as we work towards IND and our first 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 the implementation and oversight of site quality systems for AAV gene therapy for the start-up of the Durham facility, validation and registration for Zolgensma, as well as for several clinical molecules. Prior to Novartis Gene Therapies, Mr. Leising was Director of Clinical Gene Therapies Manufacturing at Pfizer’s former Bamboo Plant, overseeing the manufacturing of Phase 1 of their AAV-based gene therapies and future clinical manufacturing infrastructure. . Mr. Leising holds an MS in Biotechnology from the University of Maryland and a BS in Biology from the Florida Institute of Technology.
“Opus has an incredible opportunity to quickly transfer strong, validated science and well-characterized material into the clinic,” said Leising. “I am excited to join Opus to help drive the development of a strategic and scalable manufacturing infrastructure that can be leveraged for IND, clinical and commercial stages, for multiple products.”
About Opus Genetics
Opus Genetics is a breakthrough gene therapy company for inherited retinal diseases with a unique model and focus. Backed by the Foundation Fighting Blindness’ venture capital arm, the RD Fund, Opus combines unparalleled vision and commitment to patient needs with wholly owned programs in numerous orphan retinal diseases. Its portfolio of AAV-based gene therapies tackles some of the most overlooked forms of inherited blindness while creating new scale and orphan manufacturing efficiency. Based in Raleigh, North Carolina, the company leverages the best scientific knowledge and expertise from pioneers in ocular gene therapy to bring transformative treatments to patients in a seamless way. For more information, visit http://www.opusgenetics.com.