- In a move to become the first fully-integrated TCR T-cell therapy company, Adaptimmune Therapeutics plc has announced the manufacture of the first batch of SPEAR T-cells for a patient.
- The facility, dubbed the Navy Yard, can deliver cells for up to 300 patients a year, with potential expansion to up to 1,000 patients per year.
- Adaptimmune has also secured a dedicated vector manufacturing space in the U.K. through a deal with Cell and Gene Therapy Catapult. This will ensure vector delivery for all three SPEAR T-cell therapies for 2020 and beyond.
Cell therapies are moving into the mainstream now, with the first CAR-T cell therapies approved during the second half of 2017: Novartis' Kymriah in adult lymphoblastic leukemia (ALL) and Kite's Yescarta diffuse large B-cell lymphoma. The next big challenge will be manufacturing, and companies seem to be choosing the in-house manufacturing option. Mustang Bio, Inc. has leased a site in the UMass Medicine Science Park in Worcester, Massachusetts, and Kite and Juno Therapeutics both have leased manufacturing facilities. Adaptimmune Therapeutics plc is keeping its options more open.
"Our Navy Yard facility is now fully operational producing SPEAR T-cells for patients," said James Noble, Adaptimmune’s CEO. "We will continue to work with our cell manufacturing partner PCT, now part of Hitachi, where we have dedicated space and personnel for production of our SPEAR T-cells… Having these dedicated resources both in-house and through external partnerships is essential to ensure our future success as a fully integrated cell therapy company."
The deal with the Cell and Gene Therapy Catapult gives Adaptimmune space within a good manufacturing practice environment at CGT's U.K. manufacturing center. This includes a large-scale clean room module. Adaptimmune currently has vector supply into 2019, and having its own vector manufacturing capability at the Catapult facility will extend this supply from 2020 and beyond.
"This collaboration with Adaptimmune is a great example of a company using the capability we have developed to accelerate GMP manufacturing for global supply. It is the first announcement of a viral vector manufacturing agreement at the centre and represents part of our commitment to help U.K. companies overcome barriers to growth," said Keith Thompson, CEO, Cell and Gene Therapy Catapult.
Initial data has emerged from the two ongoing pilot studies of doses of 100 million transduced MAGE-A10 SPEAR T-cells, in non-small cell lung cancer and in bladder cancer, melanoma and head and neck cancers. There has been one serious adverse event of cytokine release syndrome in the non small cell lung cancer study, which resolved with treatment. The triple tumor study has escalated to a higher dose, 1 billion transduced cells, and the decision over escalation of the NSCLC study will be after treatment of a sixth patient.
"These safety results… are significant as they allow us to progress treating patients in these studies at a potentially active cell dose," said Rafael Amado, Adaptimmune’s CMO.