Avista Therapeutics and Forge Biologics Announce AAV Development and cGMP Manufacturing Partnership

• Avista will leverage Forge’s FUEL™ platform to manufacture AAV for AVST-101, Avista’s lead gene therapy to treat patients with X-linked retinoschisis (XLRS)

PITTSBURGH & COLUMBUS, Ohio--(BUSINESS WIRE)--Avista Therapeutics (“Avista”), a pre-clinical-stage biotechnology company developing novel AAV capsids with high efficacy and unique tropisms into innovative gene therapies for rare ophthalmic conditions, and Forge Biologics, (“Forge”), a leading manufacturer of genetic medicines and member of the Ajinomoto Bio-Pharma Services group, today announced a strategic partnership to advance the development and manufacturing of AVST-101, Avista’s lead gene therapy candidate targeting X-linked retinoschisis (XLRS), a serious inherited retinal disease.

Through this partnership, Forge will provide Avista with process development, current Good Manufacturing Practices (cGMP) manufacturing, toxicology, and analytical development services. Avista will also leverage Forge’s proprietary FUEL™ technologies, including its HEK293 suspension Ignition Cells™ and pEMBR™ 2.0 adenovirus helper plasmid. All development and manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy development and manufacturing facility in Columbus, Ohio.

“Partnering with Avista to support the advancement of AVST-101, 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.”

AVST‑101 is a next-generation gene therapy designed to treat XLRS through an innovative combination of advanced capsid engineering, efficient intravitreal delivery, low-dose efficacy, and broad retinal coverage. Its development is a significant advancement in ocular gene therapy, representing a potentially safer, more accessible option for patients with inherited retinal disease.

“Forge’s AAV-specific manufacturing expertise and platform technologies give us confidence in a smooth path forward in the development of AVST-101,” said Robert Lin, Ph.D., Chief Executive Officer of Avista. “This collaboration further strengthens our ability to advance our mission of delivering transformative gene therapies to patients with vision loss.”

About Avista Therapeutics

Avista Therapeutics’ mission is to develop innovative gene therapies for retinal diseases, including rare ophthalmic conditions that have a profound impact on patients’ quality of life. We leverage our computationally guided scAAVengr platform to generate and validate a toolkit of proprietary AAV vectors that target specific cell types using minimally invasive intravitreal delivery with reduced dosages. Our quantitative, in vivo-based approach and clinical ophthalmology expertise allow us to rapidly translate new gene therapies to the clinic. To learn more, visit https://www.avistatx.com.

About Forge Biologics

Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a gene therapy contract development and manufacturing organization (CDMO) enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com.