May 10, 2021

Smart Immune Announces FDA Orphan Drug Status, IND Acceptance and Fast-Track Designation to Commence Phase 1/2 Clinical Trial of Proprietary Allogeneic T cell progenitor Product SMART 101 (ProTcell™) for AML and ALL.

PARIS, France, May 10th, 2021 – Smart Immune SAS, a T cell medicine company utilizing its proprietary ex‐vivo biomimetic “thymus in a dish” technologyto develop proprietary allogeneic T cell progenitor product SMART 101 (ProTcellTM) for rapid reconstitution of T cell immunity, announced today that its Investigational New Drug (IND) for Acute lymphocytic leukemia (ALL) and Acute myelocytic leukemia (AML) has been accepted by the FDA. The FDA has also granted SMART 101 fast‐track designation under its Expedited Program for Serious Conditions. [...]