Wednesday, January 29, 2020
Ori Biotech estimates its automated and closed manufacturing platform can reduce COGS for autologous cell therapies by 60-80% and has teamed with HCATS to help take it to the clinic.
One of the key takeaways from this year’s Phacilitate conference last week was the need for partnerships and collaboration to overcome the many issues currently plaguing the cell and gene therapy space, and specifically manufacturing.
One such collaboration is between Hitachi Chemical Advanced Therapeutics Solutions (HCATS), the contract development and manufacturing organization (CDMO) subsidiary of Hitachi Chemical Company, and London, UK-based tech developer Ori Biotech over the latter’s cell and gene therapy manufacturing platform.
Speaking with Bioprocess Insider at the event in Miami, Ori’s CEO Jason C. Foster said the development agreement with HCATS aims to validate his firm’s processing system. If successful, he said the flexible and scalable bioreactor and fluid handling system could potentially reduce the cost of goods sold (COGS) for autologous therapies by as much as 60-80%, dramatically increasing patient access to these life-saving therapies.
The commercial success of chimeric antigen receptor (CAR) T-cell therapies such as Yescarta (axicabtagene ciloleucel) and Luxturna (voretigene neparvovec) has been blighted by their high price. Both are autologous therapies, meaning the starting material is a patient’s own cells that are then engineered and grown before being inserted back into the patient. The process is essentially the product, and thus the high cost of production leads to high prices for patients and healthcare systems.
With many autologous cell therapies moving through the clinic, an effort is clearly needed to reduce the risk, time, and human involvement – and therefore the cost – in their production, and this is what Foster said Ori’s technology aims to do.
The standardized tech is fully automated and closed, he said, and easily scalable to the extent where a small cleanroom could house tens of units.
Ori raised £7 million (about $9.4 million at the time) last year, though this was not announced until earlier this month when the company came out of stealth mode. Therefore, specific details surrounding the tech remain undisclosed for now.
However, the decision for a technology firm to work with a CDMO is “a unique concept, not normally done,” he explained, adding that HCATS’ experience with “just about every piece of cell therapy equipment” means the firm can critique the system, and help move it on to the next stage of development.
Along with two external customers, feedback will be gathered over the next six months. A next-generation version of the tech will hopefully be qualified by the end of 2020, before the system is validated by the US FDA as part of an IND application.
We asked Foster what next for Ori.
“Our ambition is to solve this very large problem – that’s the reason I got involved – and whatever the future holds for the company we want to make sure that is achieved. That could be partnering with another organization who has that interest, there certainly is a lot of interest in this area, and what we want to do is partner with the best-in-breed partners in the ecosystem and really take a partnership approach.
“We’re talking to software providers, we’re talking to raw material providers, MES [manufacturing execution system] providers; everyone who has a stake in making this system work.”