TiGenix NV is a Belgian biotech developing a Phase III cell therapy Cx601 for a complication of Crohn’s Disease which has been licensed ex-US to Takeda Pharmaceutical Company Ltd.
Cx601 is based on stem cells taken from donor adipose tissue, as an allogenic off-the-shelf cell therapy product for the treatment of complex perianal fistulas in patients with Crohn’s disease patients who do not otherwise respond to standard therapies.
Wilfried Dalemans, CTO of TiGenix, told Biopharma-Reporter that TiGenix is also working with Lonza to facilitate a new trial for registering Cx601 in the states.
“[Lonza] is now introducing our manufacturing process into their facilities in the US. Once the tech transfer is completed, they will produce clinical material,” he told us.
TiGenix is developing Cx601 in the States after an agreement with the US FDA based on a special protocol assessment procedure (SPA) in 2015. Dalemans added: “This is the first time we're working with a CMO in the US.”
For the pivotal Phase III trial for Cx601 in the US, TiGenix will use the services of a US-based contract manufacturing organization, Lonza. This trial is expected to begin in the first half of 2017, and the firm has already begun the process of transferring our technology to them for the purpose to this trial.
The Cx601 therapies are manufactured in a 2-dimensional cell culture in CF5, and according to Dalemans, do not yet need more sophisticated reactors.
To meet the manufacturing capacity for the European launch of Cx601, the current GMP facilities in Madrid are currently being expanded with the 50-50 financial support of Takeda.
Dalemans told us: “We're using local service providers for the engineering of the facility extension. For the equipment, we are at this stage still selecting who we will use to supply instruments like incubators and laminar flows etc.”
From the manufacturing site, the products are packaged in special containers to maintain a temperature between 15 – 25 degrees centigrade for transport to the clinical site.
“Cx601 is a living product - a suspension of living cells kept at room temperature. Because it’s not a frozen product, we do indeed need a cold chain supplier,” he explained.
Last July last year TiGenix partnered with Takeda to give the big pharma firm exclusive rights to commercialize Cx601 for complex perianal fistulas outside the US.
Luke Willats, a spokesperson for Takeda, told us: “Takeda is a global leader in gastroenterology, [so] the acquisition of Cx601 is just a dedication and commitment to GI - and the related complications.”
For these reasons, Takeda and TiGenix are working very closely in anticipation of the EMA approval, expected in the second half of 2017.
Dalemans explained: “We're expanding our current Madrid facility to meet the capacity that will be needed once Takeda begins to commercialise Cx601 - we're also working closely with Takeda for even further extension of the capacity.”
Willats told us that once authorization by the European regulators is obtained, Takeda will assume commercialization for Cx601 outside of the US.