The milestone: the first patient has been dosed in an investigator initiated trial (IIT) using ImmuXell’s TCR-T cell therapy manufactured on Ori’s IRO® platform.
The IIT is aiming to evaluate ImmuXell’s TCR-T therapy in patients with solid tumors harboring KRAS G12V mutations, including those with colorectal cancer, pancreatic cancer, and lung cancer — all among the deadliest and most treatment-resistant cancers. This is a proof point that the IRO® platform can take a therapy from process development to patient dosing with the speed, quality, and consistency that GMP manufacturing demands.
From platform installation to first patient dosed in four months, the Ori and ImmuXell teams working together have rapidly adapted and optimized ImmuXell’s proprietary manufacturing process on IRO®, demonstrating the platform’s flexibility without sacrificing safety, efficacy or quality. The partnership includes IRO® platform deployment at ImmuXell’s Shanghai facilities, with full scientific and technical support from Ori. The two companies plan to progress the current IIT and file an IND application in China to conduct a Phase 1 clinical trial later in 2026.
Jason C. Foster, CEO, Ori Biotech, said:
“This is the milestone we’ve been building toward for the last 7 years — IRO® manufacturing a therapy for a patient who desperately needs it. Our platform was designed to eliminate the tradeoffs that have held back cell therapy: speed vs. quality, scale vs. cost, R&D vs. GMP. This partnership with ImmuXell demonstrates that IRO® can deliver on all of them, in one of the world’s most important emerging biopharma markets, in the most intractable cancers, quickly and efficiently. We’re proud to be the manufacturing backbone for ImmuXell’s clinical ambitions, and we see this as the first step in a long and impactful collaboration.”
Dr. HongMing Hu, Founder, ImmuXell Biotech, said:
“When you’re developing therapies for cancers with no good treatment options, speed to patients is everything. IRO® let us move faster than we thought possible — adapting to our unique process, hitting our CQAs, and outperforming the flask and bag based manufacturing approach we had been using for years in just a few short months. Ori is the kind of partner that makes the impossible feel achievable. We look forward to bringing our TCR-T therapy to more patients in China this year and working together with Ori on our ex-vivo cell therapy pipeline.”
This partnership marks Ori’s first collaboration in Asia Pacific and underscores the company’s rapid global momentum. IRO® now counts 18 partners worldwide — including the recently announced partnership with AdAlta and Cell Therapies Pty in Australia as well as longstanding US partners Charles River Laboratories, CTMC, ElevateBio, and Kincell Bio, as well as other leading CDMOs and two Tier 1 pharma companies. Since its commercial launch in December 2024, IRO® has been adopted across R&D, PD and now clinical settings. Ori expects the first INDs for IRO®-manufactured products to be filed in late 2026.
About Ori Biotech
Ori Biotech is a manufacturing technology company on a mission to enable widespread patient access to life-saving cell and gene therapies. IRO®, Ori’s next-generation platform, automates better biology, accelerates development, and scales seamlessly from R&D to GMP on a single system — increasing throughput, improving quality, and reducing cost. Launched in 2024 and holder of an FDA Advanced Manufacturing Technology designation, IRO® is rapidly becoming the new standard in CGT manufacturing.
About ImmuXell Biotech
ImmuXell Biotech Co., Ltd. is a clinical-stage biotech company developing innovative TCR-T cell therapies for solid tumors. Founded in 2021 and headquartered in Shanghai, ImmuXell’s platform identifies TCRs targeting cancer driver gene mutations and tumor neoantigens, with a lead focus on KRAS mutations in pancreatic and colorectal cancers. ImmuXell secured over RMB 100 million (USD ∼$13.7M) in Series A financing, led by SDIC Venture Capital.
