The Nice-based offshoot of Inserm (the French National Institute for Health and Medical Research) says its method drastically cuts manufacturing time and cell manipulation and increases patient acceptance.
TxCell’s ASTrIA platform “educates” antigen-specific regulatory cells (Ag-Tregs) from the patient’s own blood sample to target autoimmune inflammatory diseases.
The technique starts with extracting white blood cells from the patient’s blood sample. A panel of markers then retrieves key regulatory cells.
“We educate them to respond to an antigen that’s associated with the disease site,” said Marron.
The next step is growing millions of these antigen-specific Treg cells, which are divided into doses and frozen, to be sent to the patient’s treatment centre. On injection, the cells migrate to the site of the disease, where they are activated by the relevant antigen to combat the inflammation.
Provenge ‘time-lag’ problem
“It’s a major step in cellular therapy when you can show that you have a robust and efficient manufacturing process – that’s been a problem to date,” said TxCell CEO, Damian Marron.
“The first cellular therapy to really hit the news was Provenge for prostate cancer. It works well but it struggles because they have to manufacture it [every time] they want a dose. There’s a time lag that causes difficulty around logistics and cost.”
The ASTrIA method can produce years’ worth of a personalised drug in one process.
Using the patient’s own cells makes the therapy “truly personalised”, said Marron. “We come from a very natural approach – we isolate and educate the cells rather than manipulating them. From a patient acceptance point of view, they appreciate that.”
“In the case of Ovasave [TxCell’s cellular therapy for Crohn’s disease] it’s an injection every 8 weeks. We don’t have to produce it each time,” said the CEO.
From taking the patient’s blood sample the manufacturing process of Ovasave, currently in Phase II trials, takes ten weeks, but Marron says he is confident of reducing this to four to five weeks by the time the drug goes on the market.
While the technique is widely used in oncology, Marron said TxCell was “very excited” to be the first in its field:
“We’re the only people using antigen-specific t-cells to treat autoimmune inflammatory disease.”
In the pipeline: joints, eyes and nerves
TxCell plans to create other immunotherapies with the ASTrIA platform, said Marron.
Possibilities include treating joint diseases with cells responding to Type 2 collagen antigen, or “myelin Tregs which can be targeted at autoimmune diseases such as secondary progressive multiple sclerosis, or optic myelitis,” he said.
In December, TxCell received accreditation from ANSM, the French National Agency for Drug Safety to develop its cell therapy at its facility in Besançon, France, allowing it to progress to Phase III trials with Ovasave.
The results of Ovasave’s phase I and IIa studies found 6 in 8 Crohn’s patients receiving the highest dose responded positively to the treatment.
Col-Treg is applying for ATMP classification and is preparing for a Phase II study in 2015.