May 20, 2022

Smart Immune Announces Oral Presentation of Cell Fate Plasticity Data of its T-cell Progenitor-Based Therapy Platform (ProTcell™) at ASGCT 2022

Datademonstrates Smart Immune’s technology can be used to produce both therapeutic T-cell progenitors and NK cells with reproducibility and scale

Paris, France, 20 May 2022 - Smart Immune, a clinical-stage biotechnology company focused on saving and improving lives by delivering to patients a new generation of thymus-empowered T cell medicine, announced today it has delivered an oral presentation on itspreclinical research at the 25th American Society of Gene and Cell Therapy (ASGCT) Annual Meeting, which took place from May 16-19 in Washington DC, USA.

“This research provides further evidence that our lymphoid progenitors have a plasticity that allows them todifferentiate into both T cells and NK cells. Knowing the complementary properties of these two types of cells to fight infections and cancers, this bipotency means we have an incredibly powerful and clinically-relevant asset,” commented Karine Rossignol, the Chief Executive Officer and co-founder of Smart Immune.

The data presented demonstrates that despite high expression of BCL11B (in 94.1% of ProTcell™), a protein that locks T cells into their fate, half of ProTcell™ express CD161, an early innate lymphoid cell (ILC) marker suggesting a T/NK dual potential in such cells.I nnate lymphoid cells (ILCs) are innate counterparts of T cells that contribute to immune responses by secreting effector cytokines and regulating the functions of other innate and adaptive immune cells. NK cells are a class of ILCs important for their cytolytic role against viruses and tumor cells.

Through a series of experiments, Pierre Gaudeaux and his colleague Ranjita Devi Moirangthem at the Imagine Institute have demonstrated both CD161+ and CD161- cell subpopulations in ProTcell™ differentiate into T and NK cells when cultured in the appropriate conditions. Both populations expressed thymus-homing markers (PSGL1, CCR7, CCR9, CXCR4) and resulted in full thymic engraftment when injected into immunodeficient NSGmice.

Taking advantage of this T/NK cell-fate plasticity of ProTcell™, the Company has developed a scalable, feeder-free and clinically compatible method for generating large numbers of immunotherapeutic NK cells from ProTcell™. These specific culture conditions enable efficient differentiation of ProTcell™ product into high numbers (~10,000 fold expansion)of fully potent, highly pure (>90%) NK cells with no mature T cell contaminants.

A description of all three US and European clinical trials using Smart Immune’s progenitor populations can be found on the Company’s website:

To learn more about the US clinical trial for our lead program Smart-101 in pediatric and adult leukemia, please refer to: (Trial Identifier: NCT04959903)


 About Smart Immune

Smart Immune is a clinical stage biotechnology company based in Paris, France. It was created in 2017 by Marina Cavazzana, MD, PhD, Isabelle André, PhD, and Karine Rossignol, PharmD, to unlock the potential of Allogeneic T cell medicine and change the prognosis of patients with life-threatening diseases such as high-risk leukemia and primary immunodeficiencies.

Through its patented ex vivo lymphoid niche technology, Smart Immune develops a thymus empowered T celltherapy platform called ProTcell™. It has been designed to ensure a rapid, complete, and long-lasting immune recovery to fight malignancies and infections.

About ProTcell™

The Smart Immune ProTcell™ platform generates allogenic T-cell progenitors that provide fully functional polyclonal T-cells within 3 months through thymic education. ProTcell™can be used without gene modification or with gene modification. Without gene modification ProTcell™ aims at reducing GvHD, infections and relapses there by reducing morbidity and mortality and improving the benefice risk ratio for allogeneic medicine. When infused those lymphoid progenitors migrate to the patient’s thymus where they expand, are selected, and then differentiate, resulting in fully functional T-cells, tolerant to the patient’s own immune system and reactive to viral, fungal, and malignant antigens. ProTcell™ has been accepted by the FDA as an Investigational New Drug (IND) for Acute Lymphocytic Leukemia (ALL) and Acute Myelocytic Leukemia (AML) and has also been granted fast track designation under its expedited program for serious conditions like SCID. In 2021, the FDA granted orphan drug designation and a fast-track designation for ProTcell™ as a treatment to enhance cell engraftmentin patients receiving hematopoietic stem cell transplant (HSCT) including hematologic malignancies and all forms of primary immunodeficiencies. ProTcell™is currently being studied in two clinical trials in Europe, and two in the U.S.



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