Ori LEAP partner CTMC shares biological results demonstrating new manufacturing platform can accelerate cell and gene therapy development
London, UK, and Houston, TX, US, June 3, 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.
About Ori Biotech
Ori 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 more information, visit www.oribiotech.com
About CTMC
CTMC – a joint venture between Resilience + MD Anderson Cancer Center – was created to accelerate the development and manufacturing of impactful cell therapies for patients with cancer. Our strategic position within the Texas Medical Center, combined with our expertise in TIL and CAR-T development, manufacturing, and regulatory, converge to enable an accelerated path to IND for cell therapies. By leveraging the strengths of our partners, we start clinical trials faster and provide a clear path to robust commercialization.
Follow @ctmcplus on LinkedIn and visit our website at www.ctmc.com
Contact Information
RXMD
Victoria Verdeja
Tel: +1 (646)-599-8604
Email: Media@OriBiotech.com
CTMC
Laura Torgerson
Tel: +1 (832) 295-8533
Email: ltorgerson@ctmc.com