Grace Science LLC, a biotechnology company focused on developing gene therapies for NGLY1 Deficiency, has partnered with Andelyn Biosciences Inc., a cell and gene therapy Contract Development and Manufacturing Organization (CDMO). Through this collaboration, Grace Science aims to increase program efficiency, support ongoing clinical trials, and expedite the availability of its lead drug candidate GS-100 to patients in need.
In 2021, GS-100 received orphan drug designation (ODD) from the FDA and the European Medicine Agency (EMA), potentially leading to a Priority Review Voucher upon approval for marketing and a Fast-Track designation in 2023. The recombinant AAV9 vector containing the full-length human NGLY1 gene has shown promising results in early clinical trials and holds potential for significant improvements in patient outcomes.
Andelyn Biosciences brings its expertise in AAV processes and capabilities in late-stage manufacturing and commercial readiness to the partnership. By leveraging Andelyn’s resources and experience, Grace Science aims to expedite its manufacturing timelines and offer hope to patients with NGLY1 Deficiency.
Matt Wilsey, CEO and Co-Founder of Grace Science, expressed his excitement about the partnership with Andelyn Biosciences. He noted that Andelyn’s experience and expertise in AAV gene therapy manufacturing would ensure that NGLY1 patients receive safe, high-quality drug products for clinical trials and beyond.
“We are thrilled to be collaborating with Andelyn Biosciences,” said Matt Wilsey. “Together, we share a commitment to strong collaboration, customer-centric focus, and quality first mindset.”
Matt Niloff, Chief Commercial Officer at Andelyn Biosciences, also expressed his enthusiasm for the partnership with Grace Science. He highlighted their shared values as evidence of their confidence in the success of GS-100 as a treatment option for NGLY1 Deficiency.
“We are honored to work alongside Grace Science,” said Matt Niloff. “Their dedication to finding solutions for this debilitating disease aligns with our own mission to improve patient outcomes through cutting-edge technology.”
