Forge, Skylark Ink Strategic AAV Development, cGMP Manufacturing Agreement

Editor’s Take: This partnership will provide manufacturing support for a treatment targeting underlying genetic causes of hearing loss.

Forge Biologics and Skylark Bio are launching an adeno-associated virus (AAV) development and current good manufacturing practice (cGMP) manufacturing partnership.

Skylark, a clinical-stage biotechnology company developing targeted genetic medicines for hearing loss, will leverage several of Forge’s proprietary platform technologies. Forge, which manufactures gene therapies, is part of Ajinomoto Bio-Pharma Services.

SKY-GJB2, Skylark’s lead program, is under evaluation in a Phase I/II trial to treat GJB2-related hearing loss. Globally, this is the leading genetic cause of inherited hearing loss.

AAV Therapy and How it Works

Skylark’s investigational AAV therapy delivers a functional copy of the GJB2 gene to inner ear cells affected by disease-causing mutations. SKY-GJB2 leverages Skylark’s proprietary capsid platform, engineered for targeted, low-dose delivery and durable gene expression.

Now, Forge will contribute its HEK293 suspension Ignition Cells, and pEMBR 2.0 adenovirus helper plasmid.

Forge and Skylark Share Strengths

Together, the companies say this approach may be able to address the underlying genetic cause of hearing loss.

“Our collaboration … is a shared mission to bring meaningful treatment options to patients,” John Maslowski, Forge President/CEO, said. “[We] 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 program.”

“Skylark needs a manufacturing partner who shares our commitment to excellence,” Jodi Cook, PhD, Skylark President and CEO, said. “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. They’ve integrated seamlessly with our team to help ensure our therapies are manufactured with the rigor and care patients deserve.”

All development and manufacturing activities will take place at the Hearth, Forge’s 200,000-square-foot facility in Columbus, Ohio.