RALEIGH – Opus Genetics, a gene therapy company that launched last year in the Triangle, has a new manufacturing agreement.
According to a press statement, the company formed an agreement with National Resilience, Inc., a biomanufacturing company.
The agreement will support the development and manufacturing of the startup’s pipeline, a statement reads.
National Resilience has a facility in Research Triangle Park.
The company will provide process and analytical development, quality control testing, and GMP manufacturing services for IND-enabling toxicology and first-in-human material for Opus Genetics’ adeno-associated viral (AAV) vector-based gene therapies for inherited retinal diseases (IRD), the statement notes.
Those AAV therapies will be used in both preclinical studies and future clinical trials, the statement noted.
“Resilience embraces our innovative model to create a clinical manufacturing infrastructure that’s scaled to address rare inherited retinal diseases, and we are pleased to enter into this strategic collaboration,” said Ben Yerxa, Ph.D., CEO of the Foundation Fighting Blindness and the Retinal Degeneration Fund, and acting CEO of Opus Genetics, in a statement. “Leveraging Resilience’s expertise puts Opus in the best position to efficiently advance our AAV-based gene therapies into the clinic and toward the patients who need them.”
The company was spun out of a Raleigh-based non-profit subsidiary of the Foundation Fighting Blindness, The Retinal Degeneration Fund, with $19 million from the foundation and other investors, last year.
WRAL TechWire spoke with Yerxa in December 2021, profiling the company and its work to advance its gene therapies.
“Helping Opus advance their gene therapies for inherited retinal diseases to the clinic will hopefully lead to new treatments for underserved patients,” said Rahul Singhvi, ScD, Chief Executive Officer of National Resilience, Inc.. “We’re excited to partner with Opus on process development and manufacturing at this pivotal time for the company.”
According to the statement, Opus Genetics expects to begin clinical trials for its lead candidate, OPGx-001. The company also has two other early-stage programs.