Takeda's off-the-shelf stem cell therapy closes in on EU approval

By Dan Stanton contact

- Last updated on GMT


Related tags: Stem cell

The EMA has recommended approval of the first ever off-the-shelf stem cell therapy, Takeda and Tigenix’s Alofisel (darvadstrocel).

The European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorisation of the candidate – previously known as Cx601 – last week taking Takeda and Tigenix one-step closer to landing the first EU approval for an allogeneic stem cell product.

While autologous therapies are made using a patient’s own cells within a timely and specialised supply chain, allogeneic – or ‘off-the-shelf’ – cell products can be manufactured more in line with standard biotherapeutics, with consistent pharmaceutical release criteria, over time and from batch to batch.

If given the thumbs up by the European Commission, Alofisel is expected to be indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease when fistulas have shown an inadequate response to at least one conventional or biologic therapy.

Licensing and manufacturing

Belgium-based TiGenix developed Alofisel but Takeda holds the rights for in non-US markets following a licensing agreement inked in 2016​. If a market authorisation (MA) is approved, TiGenix will receive €15m from Takeda as a milestone payment.

Alofisel is made in plastic flasks in incubators at a one-litre scale, using stem cells taken from healthy volunteers who have undergone liposuction for cosmetic reasons at TiGenix’s facility in Madrid, Spain.

However, Takeda aims to take over responsibility for the production from 2021​ from a purpose built manufacturing facility in Europe. Details about the facility are yet to have been divulged.

In the US, where TiGenix still holds the rights, trial material is being produced by contract manufacturing organisation (CMO) Lonza, which underwent tech transfer at its site in Maryland in February​.

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