The FDA has backed Kiadis Pharma’s lead blood cancer product by granting it the Regenerative Medicine Advanced Therapy designation.
Kiadis Pharma, based in Amsterdam, develops products to make bone marrow transplants for the treatment of blood cancer and inherited blood disorders safer and more effective. Their lead T cell immunotherapy candidate, ATIR101, reduces the risk of complications, and it entered Phase III earlier this year. Its new Regenerative Medicine Advanced Therapy (RMAT) designation helps important new treatments for serious or life-threatening conditions reach approval quicker.
ATIR101 works by removing T cells that could cause complications, such as Graft-versus-Host-Disease while leaving those that protect against cancer and infections. This technology means only a partial match is required for hematopoietic stem cell transplants, which would be a massive boost to patient eligibility.
The future is looking bright for Kiadis, as Arthur Lahr, CEO, explained: “We are now going to work even closer with the FDA to agree a path to make this cell therapy treatment available for patients in the US as soon as possible. In Europe, ATIR101 was filed for registration in April 2017 and we continue to prepare the Company for the potential European launch in 2019.” But, this is just one of a number of biotechs, including Novartis, MorphoSys and Adaptimmune leading the fight against blood cancer in Europe.
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