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Ori Biotech and Charles River Laboratories Collaborate to Accelerate Life-Saving Cell and Gene Therapy Development and Manufacturing.

New Biological Data Released from IRO® Cell Therapy Manufacturing Platform

Philadelphia, PA, September 18, 2024 – Ori Biotech (Ori), a leader in cell and gene therapy (CGT) manufacturing enabling technology, and Charles River Laboratories (Charles River), a global industry-leading drug discovery, preclinical development, manufacturing and testing solutions provider, today announced a collaboration to demonstrate the benefits of Ori’s next-generation CGT manufacturing platform, IRO®(ee-RO).

In early 2024, Ori and Charles River collaborated through Ori’s LightSpeed Early Access Program (LEAP), designed to provide access to the IRO platform for use in clinically relevant applications. During the collaboration, Ori and Charles River conducted head-to-head process runs comparing the IRO platform’s biological performance to a process Charles River specifically optimized for CAR-T therapy over two years using an alternative cell therapy manufacturing technology.

With minimal process optimization, the IRO platform performed at least as well in some metrics and outperformed the current process in both cell growth and total CAR+ cells out of the box. IRO achieved an average of 51% CAR+ expression and 2.1 billion total CAR+ cells in a seven-to-eight-day process versus 1.6 billion total CAR+ cells in the legacy manufacturing technology.

“We are excited to share this data from our ongoing partnership with Charles River, showcasing the IRO platform’s ability to simultaneously deliver both superior biological performance and the benefits of automation,” said Jason C. Foster, CEO, Ori Biotech. “For too long, therapy developers have had to sacrifice biological performance for automation, but not anymore. IRO automates better biology to solve critical manufacturing bottlenecks and improve product viability by dramatically increasing throughput, decreasing COGS, and reducing batch failures, with the ultimate goal of enabling widespread patient access to life-saving cell and gene therapies.”

“Charles River’s work with Ori is part of a larger commitment to improve and scale advanced therapies through the adoption of cutting-edge closed and automated platforms to meet the growing patient demand for life-saving therapies. The test of Ori’s new IRO platform using head-to-head process transfer runs shows promising results and provides therapeutic developers another option for manufacturing and helps to address the manufacturing bottleneck challenge,” said Matthew Hewitt, B.A. PhD, Vice President, CTO Manufacturing Business Division, Charles River.

Ori and Charles River will continue collaborating to ensure next generation cell products have IRO platform access to enable their clinical development and to scale their clinical and commercial impact. IRO can significantly reduce therapy development timelines, bringing life-saving products to patients more quickly, reducing labor up to 70%, cutting the cost of goods up to 50%, reducing processing times by approximately 25%, and reducing tech transfer times from months to weeks.

To learn more about the recently launched IRO platform, visit oribiotech.com/IRO.

About Ori Biotech

Ori Biotech is a London and Philadelphia-based manufacturing technology company on a mission to enable widespread patient access to life-saving cell and gene therapies. IRO®, Ori’s next-generation manufacturing platform automates better biology, accelerates product development and enables therapy developers to scale their products’ clinical and commercial impact by seamlessly transitioning from R&D to GMP on one platform. The promise of the innovative Ori platform is to automate cell therapy manufacturing, increasing throughput, improving quality and decreasing costs by combining proprietary hardware, consumables, software, data and analytics.

For news and updates, visit oribiotech.com/news

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