Avista Therapeutics Partners with Forge Biologics to Advance AVST-101 Gene Therapy for X-linked Retinoschisis
Key Insights
Avista Therapeutics (search) and Forge Biologics (search) have formed a strategic partnership to develop and manufacture AVST-101 (search), a gene therapy targeting X-linked retinoschisis (search) (XLRS).
AVST-101 (search) represents a next-generation approach combining advanced capsid engineering, intravitreal delivery, and low-dose efficacy for treating inherited retinal disease (search).
Forge will provide comprehensive development services including cGMP manufacturing, process development, toxicology, and analytical services at their 200,000 square foot facility in Columbus, Ohio.
Avista Therapeutics (search), a pre-clinical-stage biotechnology company developing novel AAV capsids for rare ophthalmic conditions, has announced a strategic partnership with Forge Biologics (search) to advance the development and manufacturing of AVST-101 (search), its lead gene therapy candidate targeting X-linked retinoschisis (search) (XLRS). The collaboration positions Avista to leverage Forge's specialized AAV manufacturing capabilities and proprietary platform technologies to accelerate the development of this innovative treatment for a serious inherited retinal disease (search).
Comprehensive Manufacturing Partnership
Through this partnership, Forge will provide Avista with a full suite of development services including process development, current Good Manufacturing Practices (cGMP) manufacturing, toxicology, and analytical development services. The collaboration will utilize Forge's proprietary FUEL™ technologies, including its HEK293 suspension Ignition Cells™ and pEMBR™ 2.0 adenovirus helper plasmid, to manufacture AAV for AVST-101 (search).
All development and manufacturing activities will be conducted at the Hearth, Forge's 200,000 square foot gene therapy development and manufacturing facility located in Columbus, Ohio. Forge Biologics (search) operates as a leading manufacturer of genetic medicines and is a member of the Ajinomoto Bio-Pharma Services (search) group.
Next-Generation Gene Therapy Approach
AVST-101 (search) represents a significant advancement in ocular gene therapy, designed to treat XLRS through an innovative combination of advanced capsid engineering, efficient intravitreal delivery, low-dose efficacy, and broad retinal coverage. The therapy is positioned as a potentially safer, more accessible option for patients with inherited retinal disease (search) compared to existing approaches.
"Partnering with Avista to support the advancement of AVST-101 (search), their innovative intravitreal gene therapy for XLRS, aligns with our mission to help our clients accelerate the path to gene therapies for patients with urgent needs," said John Maslowski, President and Chief Executive Officer of Forge. "Our AAV manufacturing services are designed to support programs like Avista's with the speed, consistency, and quality required for success."
Strategic Positioning for Development
The partnership provides Avista with access to specialized AAV manufacturing expertise and platform technologies designed to streamline the development process. Robert Lin, Ph.D., Chief Executive Officer of Avista, emphasized the strategic value of the collaboration: "Forge's AAV-specific manufacturing expertise and platform technologies give us confidence in a smooth path forward in the development of AVST-101 (search). This collaboration further strengthens our ability to advance our mission of delivering transformative gene therapies to patients with vision loss."
The partnership represents a focused approach to addressing the manufacturing challenges associated with AAV-based gene therapies, particularly for rare ophthalmic conditions where specialized delivery methods and precise dosing are critical for therapeutic success.