Smart Immune administers final dose to adult acute leukemia patient in Phase I/II ReSET-02 trial

PARIS, France, May 2, 2024 – Smart Immune, a biotechnology company in the clinical trial stage, is focusing on developing ProTcell, a platform for thymus-empowered T cell progenitor therapy aimed at swiftly rearming the immune system against cancer and infections. Recently, the company achieved a significant milestone by treating the first patient in the third and final dose group of the dose-escalation phase in its ReSET-02 trial. This marks a crucial step in the evaluation of SMART101 for post-transplant hematology.

The ReSET-02 trial (NCT05768035) is a Phase I/II multi-center, open-label, dose-escalation study designed to assess the safety and efficacy of Smart Immune’s leading asset, SMART101. This allogeneic T cell progenitor therapy is administered following allogeneic HSCT combined with post-transplant cyclophosphamide (PTCy) in adult patients with acute lymphoid leukemia. Progressing to the final dose level of 9.0 x 10^6 CD7+ cells per kg of body weight follows favorable safety profiles observed in earlier dose levels. The therapy aims to expedite T cell reconstitution in the body to combat relapse and infection, thereby enhancing overall and disease-free survival rates post-transplant.

Karine Rossignol, CEO and Co-founder of Smart Immune, expressed excitement over reaching this significant milestone, noting the excellent tolerability and safety observed so far. "We are thrilled to achieve this key milestone in our ReSET-02 trial after observing an excellent safety profile with no dose-limiting toxicities or safety issues at the first two dose levels. Reaching the final dose brings us closer to quickly resetting the immune system with a new fit T cell compartment, improving clinical outcomes for patients with high-risk cancers. Encouragingly, all preliminary immune reconstitution data, even in patients aged 50-70 years, point in the right direction."

To date, no related safety events have been reported in the ReSET-02 trial. This positive safety profile is further corroborated by data from other Smart Immune-sponsored trials in both 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 received Orphan Drug Designation (ODD) from the European Medicines Agency and the US Food and Drug Administration (FDA), as well as Fast Track Designation from the FDA. These designations highlight its potential as a treatment to improve clinical outcomes in patients receiving allo-HSCT.

About Smart Immune

Smart Immune is a clinical-stage biotechnology company working on ProTcell, a thymus-empowered T cell progenitor platform aimed at rapidly rebuilding the immune system to fight off cancer and infections. The company’s mission is to significantly improve outcomes for patients in hematology and immuno-oncology. SMART101 is currently undergoing Phase I/II trials for patients with acute leukemia or severe combined immunodeficiencies (SCID) in both the EU and the US. Further clinical applications are planned to be explored in conjunction with innovative cancer therapies.

About the ReSET-02 Clinical Trial

The ReSET-02 trial is a Phase I/II multi-center, open-label, dose-escalation study evaluating the safety and efficacy of SMART101 after haploidentical peripheral blood stem cell transplantation with post-transplant cyclophosphamide in patients with hematological malignancies. The study involves different dose levels (1.5 x 10^6 CD7+ cells per kg of body weight, 4.5 x 10^6 CD7+ cells, and 9.0 x 10^6 CD7+ cells per kg of body weight). The Phase II part of the trial is enrolling patients into two cohorts based on the intensity of their conditioning chemotherapy and is following a Simon’s 2-stage design. This study is being conducted at multiple sites in France and Italy.

About SMART101

SMART101 is developed ex vivo within seven days from allogeneic blood stem cells using Smart Immune’s ProTcell T cell therapy platform. When injected into patients, these human T cell progenitors migrate to the thymus, where they mature into fully functional and self-tolerant T cells. Preclinical data suggests that this platform could reconstitute the immune system within 100 days, significantly faster than the typical 12 to 18 months, thus providing better protection against infections and relapses.

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