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

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Smart Immune 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.

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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.

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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.

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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. ”

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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.”