Smart Immune Announces Recommended SMART101 Dose for Adult Cancer Proof-of-Concept Trials

• ReSET-02 dose escalation Phase I is completed
• Phase II PoC randomized segment is starting

• No dose-limiting toxicities, no safety or tolerability issues
• The highest dose is to be used in both hematological and solid tumors

Paris, France – October 23, 2024 – Smart Immune, a clinical-stage biotechnology company pioneering ProTcell, a thymus-empowered T-cell progenitor therapy platform, today announced that the recommended dose for its lead candidate, SMART101, has been established following the completion of the ReSET-02 trial dose escalation segment.

This international multicenter study is evaluating the safety and efficacy of a single infusion of SMART101 administered after a standard-of-care HLA-mismatched allogeneic stem cell transplant in adult patients with hematological malignancies such as acute leukemia or myelodysplastic syndrome. Patients were treated with three doses of SMART101 at 1.5, 4, and 9 million cells per kg of body weight. No toxicities and no primary graft failures were reported. Patients didn't experience severe acute graft versus host disease or serious adverse events related to SMART101. This data demonstrates an excellent tolerability and safety profile of SMART101.

Based on these results, Smart Immune has established the highest dose of 9 million CD7+ cells per kg of body weight to be used in adult patient proof-of-concept cancer trials evaluating SMART101 in hematology and solid tumors.

The recommended dose choice was endorsed by the Chair of the Independent Data Monitoring Review Committee after examining all the data from segment 1 of the trial.

In addition, the preliminary data on immune recovery is very promising in patients treated with intermediate and high doses of SMART101 and should be further confirmed by the randomized part of the trial.

Dr. Raynier DEVILLIER, Team Leader, Allogeneic Immunotherapy – Paoli-Calmettes Institute, Comprehensive Cancer Center at Marseille, France, said: “As an investigator for the ReSET-02 study, I've been pleased by the tolerability and safety profile of SMART101 among our cohort, which is composed of elderly and fragile patients. As it may offer the greatest potential for efficacy, establishing the maximum dose level as the recommended regimen for adult cancer patients is very promising. I'm thrilled to continue contributing to this line of research. ”

Dr. Rahim FANDI, Chief Medical Officer of Smart Immune, added: “This is an important step in the development of SMART101. Following the determination of the recommended dose, we have launched the randomized part of the ReSET-02 study, and we are preparing new proof-of-concept trials in immune-oncology, notably in solid tumor indications. This is a major milestone for Smart Immune to contribute to the fight against cancer and bring new therapeutic options to patients.”

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 primary immunodeficiencies (PID), 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/
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About the ReSET-02 clinical trial

ReSET-02 is a first-in-human, open-label, randomized, multicenter phase I/II study evaluating the safety and activity of a single infusion of SMART101 post-HSCT in adult patients with hematological malignancies eligible for an HLA-mismatched PT-Cy HSCT as standard of care.

In the Phase II segment, patients will be randomized to receive SMART101 after HSCT (SMART101 arm) or the standard of care with HSCT (SoC; control arm). This will allow generating an internal control group. The trial is currently conducted at multiple sites in France and Italy and coordinated by Fabio Ciceri (San Raffaele Hospital, Milan, IT). 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:

Pauline Rodrigue

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