Smart Immune to Present ReSet-02 Phase I Preliminary Data and the Determination of the Recommended Dose at ASH 2024

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PARIS, France, 05 November 2024 – Smart Immune, a clinical-stage biotechnology company developing ProTcell, a thymus-empowered T cell progenitor therapy platform to fully and rapidly re-arm the immune system against tumors and infection, today announced the acceptance of a poster highlighting Phase I dose escalation data from its ReSET-02 trial that will be presented at the American Society of Hematology Annual Meeting, on December 7-10, 2024, in San Diego, California.

ReSET-02 is an international multicentric study evaluating our lead candidate SMART101 in the standard-of-care “HLA mismatched PTCy” HSCT setting for adult patients with blood cancers, such as acute leukemia or myelodysplastic syndrome.

In October, the recommended dose of SMART101 for adult cancer proof-of-concept trials was established at the highest level tested, underscoring its excellent safety and tolerability profile. The rationale of the dose definition has been shared in a press release.

The poster will showcase the detailed safety data collectedin the dose escalation segment of the trial, and preliminary data regarding immune reconstitution.

Smart Immune thanks all contributors for this milestone and invites attendees to the poster presentation to get an overview of the early findings from the ReSET-02 trial and the ProTcell platform.

Details:

Title: SMART101 Donor T-Lymphoid Progenitors to Accelerate Immune Reconstitution Post HLA Mismatched Peripheral Blood Stem Cell Transplantation with Post-Transplant Cyclophosphamide: Reset-02 First-in-Human Phase I/II

Session Name: 704. Cellular Immunotherapies: Early PhaseClinical Trials and Toxicities: Poster II

Session Date: Sunday, December 8, 2024

Presentation Time: 6:00 PM - 8:00 PM

Location: San Diego Convention Center, Halls G-H

*HLA-mismatched PTCy: In this setting, blood stem cell transplantation is followed by the administration of cyclophosphamide to prevent the risk of GvHD (graft versus host disease, one major complication after allo-HSCT).

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