Ori Biotech taps MD Anderson, National Resilience joint venture to put its automated cell and gene therapy manufacturing tech to the test

With manufacturing still a major pitfall for cell and gene therapy players at all stages, Ori Biotech was founded to provide assistance with the complex process. Now, its tech is poised to see real-world use.

Ori has unveiled the inaugural public partner under its LightSpeed Early Access Program (LEAP), designed to give cell and gene therapy developers, manufacturers, medical centers and others a first crack at the company’s experimental production platform.

Under the deal, Ori will team up with the Cell Therapy Manufacturing Center (CTMC)—a joint venture from MD Anderson Cancer Center and manufacturer National Resilience—to speed up process development, clinical trials and potential commercialization of new cell therapies, the partners said Tuesday.

The company's platform—which seeks to simplify the cell and gene therapy manufacturing odyssey—is propped up by three main pillars, the company’s CEO Jason Foster said in a recent interview. Those are: novel biology, robotics and automation, and the cloud, the helmsman explained.

The initial biological component centers around a novel bioreactor system Ori hopes will allow it to culture higher-quality cells faster and cheaper than possible under current production processes, Foster explained.

Second, Ori aims to automate portions of the cell and gene therapy manufacturing process that are often done by hand today, such as fluid handling. Foster described that step as a “rate limiter,” noting manual portions of the process open the door to variability and higher costs.

Finally, Ori’s approach leverages a “cloud native data platform,” which enables the company and its partners to “see inside the system in real time,” Foster said. The approach is designed to let Ori and its developer partners parse their processes in real time and “react accordingly,” the Ori CEO said.

To start, the collaboration will wed Ori’s tech with an unnamed cell therapy invented by MD Anderson lymphoma and myeloma professor Sattva Neelapu, M.D.

The partners have already put pins in several objectives for the project, including adapting and digitizing current CTMC CAR-T processes onto Ori’s tech, with the goal to help suss out the technical feasibility of the company’s platform, Ori said in a release. Further, CTMC will conduct process comparability runs to demonstrate successful product transfer as well as weigh Ori’s approach against the center’s existing in-house manufacturing methods.

As for when Ori’s platform could launch commercially, the current plan remains to put the company’s test platform into partners’ hands by late 2022 and early 2023, Foster said.

Once the testing phase is wrapped and Ori is confident in its platform, the company will start its commercial pivot, Foster said.

“Ideally,” the company could launch its platform within “the next 18 months or so,” Foster said, flagging early 2024 or potential late 2023 targets in a “best case” scenario.

Unveiled in tandem with a $100 million fundraising round in January, Ori’s LightSpeed Early Access Program aims to help Ori link arms with its partners to learn the “good the, the bad and the ugly” about its platform, rather than simply “throwing a piece of technology over the wall,” Foster explained.

Ori also aims to capture data across sources to pool lessons and expertise for its CTG developer clients, Foster said. For LEAP, Ori is seeking partnerships in three main areas: academic research, contract manufacturing and development.

Ori hopes to have five to six lead LEAP partners between now and the first half of 2023, Foster said, noting it will continue to work with other collaborators during that stretch, too.

Meanwhile, Ori is growing on the heels of its hefty series B. The company is bolstering its physical footprint in England and New Jersey, with around 50 total current staff.

The goal is to increase Ori’s workforce to about 70 people by year-end, followed by the addition of another 50 jobs in 2023, if all goes to plan, the CEO added.

CTMC, for its part, launched in June as a joint venture between manufacturing arriviste Resilience and the University of Texas MD Anderson Cancer Center. 

The Cell Therapy Manufacturing Center operates a 60,000-square-foot facility picked up from Bellicum, a CTMC spokesperson said over email. CTMC has been manufacturing for two years and works on the entire cell therapy process, including process development, analytical development, manufacturing, quality control, quality assurance and regulatory, the Center's spokesperson added. 

Alongside Ori, CTMC also has partnerships with Invectys and Obsidian, she pointed out.

Last month, meanwhile, Resilience forged a similar pact with the Mayo Clinic to crank out drugs for complex and rare diseases. That partnership will home in on biologics derived from sources like cells, blood, enzymes, tissues, genes or genetically engineering cells, Resilience said in an August release.

Editor's note: This article was updated to add details about CTMC and to correct a statement about construction of the Center's manufacturing facility.