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Smart Immune treats adult acute leukemia patient at final dose level in Phase I/II ReSET-02 trial
Smart Immune treats adult acute leukemia patient at final dose level in Phase I/II ReSET-02 trial PARIS, France, May 2, 2024 – Smart Immune, a clinical-stage biotechnology company developing ProTcell, a thymus-empowered T cell progenitor therapy platform to rapidly re-arm the immune system against cancers and infections, today announces the treatment of the first patient in the third and final dose cohort of the dose-escalation stage in its ReSET-02 trial. This is an important milestone in the evaluation of SMART101 in post-transplant hematology. The ReSET-02 trial (NCT05768035) is a Phase I/II multi-center, open-label, dose-escalation study to assess the safety and efficacy of Smart Immune’s lead asset, SMART101, an allogeneic T cell progenitor therapy, after allogeneic HSCT with post-transplant cyclophosphamide (PTCy), in adult patients with acute lymphoid leukemia. The trial has progressed to the final dose (9.0 x 106 CD7+ cells per kg of body weight) cohort after favorable safety profiles observed in patients treated with the first and second dose levels. The product candidate is designed to accelerate T cell reconstitution to fight relapse and infection and improve overall and disease-free survival post-transplant. Karine Rossignol, CEO and Co-founder, Smart Immune said: “We are thrilled to achieve this key milestone in our ReSET-02 trial after observing an excellent tolerability and safety profile with no dose limiting toxicities or safety issues with the first two dose levels. Reaching the final dose brings us a step closer in our efforts to quickly reset the immune system with a new fitT cell compartment, improving clinical outcomes in patients with high-risk cancers. Encouragingly, all preliminary immune reconstitution data, even in patients aged 50-70 years, point in the right direction.” No related safety events have been reported to date in the ReSET-02 trial. This encouraging safety profile is further confirmed by the other Smart Immune-sponsored trial data in Europe and the US. SMART101 is an allogeneic cell therapy produced from healthy donor mobilized peripheral blood stem cells (CD34+) differentiated into T cell progenitors. It has been granted Orphan Drug Designation (ODD) by the European Medicines Agency and the US Food and Drug Administration (FDA), in addition to Fast Track Designation by the FDA, as a treatment to enhance clinical outcomes in patients receiving allo-HSCT. About Smart Immune Smart Immune is a clinical-stage biotechnology company developing ProTcell, a thymus-empowered T cell progenitor platform to rapidly re-arm the immune system against cancer and infection. The company aims to radically improve outcomes for patients in hematology and immuno-oncology. SMART101 is in Phase I/II trials for patients with acute leukemia or severe combined immunodeficiencies (SCID), in the EU and the US. Additional clinical applications are planned to be evaluated in combination with innovative cancer therapies. https://www.smart-immune.com/ About the ReSET-02 clinical trial SMART101 is being evaluated in the ReSET-02 Phase I/II multi-center, open-label, dose-escalation study (1.5 x 106 CD7+ cells per kg of body weight, 4.5 x 106 CD7+ cells and 9.0 x 106 CD7+ cells per kg of body weight) to evaluate the safety and activity of SMART101 after haploidentical peripheral blood stem cell transplantation with post-transplant cyclophosphamide, in patients with hematological malignancies. In the Phase II segment, patients are being enrolled in parallel into two cohorts according to the intensity of the conditioning chemotherapy and in two consecutive stages according to a Simon’s 2-stage design. The trial is currently conducted at multiple sites in France and Italy. For more information, visit www.clinicaltrials.gov, study identifier number NCT05768035. About SMART101 SMART101 is generated ex vivo in 7 days from allogeneic blood stem cells, using Smart Immune’s ProTcell T cell therapy platform. Once injected into the patient, the SMART101 human T cell progenitors travel to the thymus where they are educated to become fully functional and self-tolerant T cells. Preclinical data suggest that the ProTcell platform could reconstitute the immune system in 100 days instead of the 12 to 18 months observed in physiology, thereby protecting patients from infection and relapse. Media contact: ICR Consilium 
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