Andelyn Biosciences Collaborates with Grace Science to Enhance GS-100

Grace Science LLC and Andelyn Biosciences Inc., two leading players in the cell and gene therapy industry, have teamed up to accelerate the development of GS-100, a suspension process AAV NGLY1 gene therapy for Phase I/II/III clinical trial material. This partnership is aimed at maximizing program efficiency, supporting ongoing clinical trials, and bringing hope to patients suffering from NGLY1 Deficiency.

GS-100 is a recombinant AAV9 vector that encodes a full-length version of the human NGLY1 gene. It was granted orphan drug designation (ODD) by the FDA and EMA in 2021, along with Rare Pediatric Disease Designation by the FDA. Grace Science successfully dosed the first NGLY1 Deficiency patient with GS-100 in February of this year and plans to dose the second patient in May 2024.

In this collaboration, Grace Science will leverage Andelyn’s expertise in AAV processes and capabilities in late-stage manufacturing and commercial readiness to speed up their manufacturing timelines. Matt Niloff, Chief Commercial Officer at Andelyn Biosciences, emphasized the strong collaboration and customer-centric focus shared by both companies, providing confidence and hope for the success of the GS-100 program.

Matt Wilsey, CEO and Co-Founder of Grace Science, expressed excitement about the partnership, stating that Andelyn’s expertise in AAV gene therapy manufacturing will ensure that NGLY1 patients have access to safe, high-quality drug products for their clinical trial and beyond. The partnership between Andelyn Biosciences and Grace Science aims to bring hope and relief to patients suffering from NGLY1 Deficiency through the development and manufacturing of GS-100.

This partnership highlights the importance of collaboration between CDMOs and biotech companies in bringing innovative therapies to market faster. With this collaborative effort, we can expect GS-100 to reach clinical trial material soon while ensuring its safety for patients with NGLY1 Deficiency.

By Riley Johnson

As a content writer at newsmol.com, I dive into the depths of information to craft compelling stories that captivate and inform readers. With a keen eye for detail and a passion for storytelling, I strive to create engaging content that resonates with our audience. Whether it's breaking news, in-depth features, or thought-provoking opinion pieces, I am dedicated to delivering high-quality, informative content that keeps readers coming back for more. My goal is to bring a fresh perspective to every article I write and to make a meaningful impact through the power of words.

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