- Skylark Bio and Forge Biologics have entered a strategic partnership for AAV process development, analytical development and cGMP manufacturing services.
- The collaboration will support SKY-GJB2, Skylark’s Phase 1/2 gene therapy program for GJB2-related hearing loss, with development and manufacturing activities taking place at Forge’s facility in Columbus, Ohio.
Skylark Bio and Forge Biologics have announced a strategic partnership covering adeno-associated virus (AAV) development and cGMP manufacturing activities for Skylark’s gene therapy programs. Under the agreement, Forge will provide process development, analytical development and cGMP manufacturing services while supporting Skylark through its proprietary FUEL™ platform technologies. All work will be conducted at the Hearth, Forge’s 200,000-square-foot gene therapy development and manufacturing facility in Columbus, Ohio.
The partnership is intended to support Skylark as it advances its lead candidate, SKY-GJB2, into clinical development. The investigational AAV gene therapy is currently being evaluated in a Phase 1/2 clinical trial for GJB2-related hearing loss, which the company describes as the leading genetic cause of inherited hearing loss worldwide.
According to Skylark, SKY-GJB2 is designed to deliver a functional copy of the GJB2 gene directly to cells in the inner ear affected by disease-causing mutations. The company said the therapy has the potential to address the underlying genetic cause of hearing loss and utilizes its proprietary capsid platform for targeted, low-dose delivery and durable gene expression.
As part of the collaboration, Skylark is also using Forge’s HEK293 suspension Ignition Cells™ and pEMBR™ 2.0 adenovirus helper plasmid technologies. The companies stated that the partnership combines Forge’s manufacturing and development capabilities with Skylark’s genetic medicine platform to support ongoing clinical advancement.
“At the heart of our collaboration with Skylark is a shared mission to bring meaningful treatment options to patients. By combining our platform technologies with manufacturing expertise, we are proud to support Skylark as it advances its gene therapy program through clinical development.”
John Maslowski, President and Chief Executive Officer of Forge
