Cambridge, Mass.– Skylark Bio and Forge Biologics have announced a strategic AAV development and cGMP manufacturing partnership to support Skylark’s clinical-stage gene therapy program for genetic hearing loss.
Skylark is a clinical-stage biotechnology company developing targeted genetic medicines for hearing loss. Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a gene therapy manufacturer.
Under the partnership, Forge will provide Skylark with process development, current good manufacturing practice manufacturing, and analytical development services. Skylark will also use Forge’s proprietary FUEL platform technologies, including its HEK293 suspension Ignition Cells and pEMBR 2.0 adenovirus helper plasmid.
The development and manufacturing work is being conducted at the Hearth, Forge’s 200,000-square-foot gene therapy development and manufacturing facility in Columbus, Ohio.
“As we enter the clinic with our lead program, Skylark needs a manufacturing partner who shares our commitment to excellence,” said Jodi Cook, Ph.D., President and Chief Executive Officer of Skylark. “Forge provides the partnership we need to confidently advance our research into clinical development. Their end-to-end AAV gene therapy manufacturing capabilities provide exactly the foundation we’re looking for, and they’ve integrated seamlessly with our team to help ensure our therapies are manufactured with the rigor and care that patients deserve.”
Skylark’s lead program, SKY-GJB2, is being evaluated in a Phase 1/2 clinical trial for GJB2-related hearing loss, the leading genetic cause of inherited hearing loss worldwide.
The investigational AAV gene therapy is designed to deliver a functional copy of the GJB2 gene directly to cells in the inner ear affected by disease-causing mutations. Skylark said the therapy has the potential to address the underlying genetic cause of hearing loss.
SKY-GJB2 uses Skylark’s proprietary capsid platform, which is engineered for targeted, low-dose delivery and durable gene expression.
“At the heart of our collaboration with Skylark is a shared mission to bring meaningful treatment options to patients,” said John Maslowski, President and Chief Executive Officer of Forge. “This partnership reflects our focus on improving how gene therapies are made so more promising medicines can reach those who need them. By combining our platform technologies with manufacturing expertise, we are proud to support Skylark as it advances its gene therapy program through clinical development.”
