Ori LEAP partner CTMC shares biological results demonstrating new manufacturing platform can accelerate cell and gene therapy development
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LONDON and HOUSTON, June 03, 2024 – Ori Biotech Ltd. (Ori), a leader in cell and gene therapy (CGT) manufacturing technology, and CTMC – a joint venture between Resilience + MD Anderson Cancer Center, announces promising results for IRO, Ori’s newly launched next-generation CGT manufacturing enabling platform. Ori Biotech CEO Jason C. Foster and CTMC Co-Founder + CEO Jason Bock revealed the companies’ findings at the 30th annual International Society for Cell & Gene Therapy (ISCT) Conference in Vancouver, Canada.
Manufacturing remains a critical barrier to scaling cell and gene therapies, thus far, limiting the clinical and commercial impact of this life-saving new class of therapies. The IRO provides both the flexibility needed for early process development and the ability to scale into GMP manufacturing in one platform potentially shaving years off the drug development timeline for a cell therapy. Through their collaboration, Ori and CTMC evaluated the IRO platform’s capabilities to manufacture a clinical-stage CAR-T asset, showing superior biological performance when compared to the current manufacturing process.
Over the course of 9 biological runs at 2 different sites, the IRO platform consistently demonstrated higher cell yields and a higher average transduction efficiency of approximately 69% compared to 45% with the current manufacturing process leading to shorter manufacturing times with reduced COGS. Additionally, IRO demonstrated the capability to do rapid process transfer, as evidenced by the two successful process establishments both at CTMC in Houston and their Resilience partner site outside of Philadelphia in just a few weeks.
“For too long, scientists and therapy developers have had to sacrifice biological performance for automation. Not anymore; with IRO we are Automating Better Biology.” said Foster. “This data showcases the ability of the IRO platform to provide superior biological performance, accelerate therapy development, and scale the clinical and commercial impact of these incredible therapies. I believe IRO will quickly become the new standard for CGT manufacturing technology.”
The collaboration between Ori and CTMC, which began in 2022, granted CTMC pre-commercial access to Ori’s technology to demonstrate the IRO platform’s technical feasibility in CTMC labs run by CTMC’s team. This partnership demonstrates the companies’ shared commitment to transforming CGT manufacturing practices and enhancing patient access to life-saving treatments worldwide. The partners have gone on to have a Type D meeting with FDA to discuss process comparability and are currently evaluating several other clinical programs for possible collaboration.
“What initially attracted us to this partnership was the flexibility of the IRO platform in terms of the design of the novel bioreactor system which returns control of process optimization to our process scientists, enabling comprehensive optimization,” said Bock. “I expected automation, I expected more process insight, but I never expected better biological performance right out of the gate. Further, this collaboration on a cell therapy currently in the clinic, was a great vehicle for us to discuss and align our product development strategy with the FDA.”
To learn more about the IRO platform or to schedule a demo, visit www.oribiotech.com/iro.
