November 2, 2023

Smart Immune to Present Details of Pioneering Clinical Study at the American Society of Hematology (ASH) Annual Meeting 2023

Smart Immune has announced that a poster featuring SMART101, the first T cell progenitor therapy productin development from the Company’s ProTcell platform, will be presented at the American Society of Hematology (ASH) Annual Meeting to beheld 09-12 December 2023 in San Diego, California.

The poster will present details of the ReSET-02 clinical study that is underway seeking to provide proof of concept that a novel type of T cell progenitor cells – the Company’s SMART101 asset – can  rapidly complete their differentiation into naïve T cells within a patient’s thymus, accelerating the reconstitution of a fully-competent polyclonal T cell repertoire after allogeneic hematopoietic stem cell transplantation (allo-HSCT). In this protocol, adult leukemia patients will undergo a specific blood stem cell transplant procedure, called ‘Haplo PTCy’, from a haploidentical donor (i.e., a family member not fully compatible), followed by the administration of cyclophosphamide that reduces the risks of graft-versus-host disease (GvHD). Six days after thetransplantation, the patients will receive an infusion of SMART101, produced in Paris, from the same healthy donor.

An improvement in allo-HSCT clinical outcomes is expected from thisfirst-of-a-kind thymus-empowered approach, leading to better overall survival and lower co-morbidity rates. If the primary endpoints are met as anticipated, the study will also show the biological activity of SMART101 to reverse thymic involution.

Poster details

Title: SMART101 Donor T-Lymphoid Progenitors to Accelerate Immune Reconstitution Post-Haploidentical Peripheral Blood Stem Cell Transplantation with Post-Transplant Cyclophosphamide: SI101-02 First-in-Human Phase I/II

Session Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster III

Session Date: Monday, December 11, 2023

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

Location: San Diego Convention Center, Halls G-H

Publication Number: 4861 Presenters: Marina Cavazzana, MD, PhD, Co-founder and Strategic Clinical Development Advisor, Smart Immune

Karine Rossignol, Co-founder and Chief Executive Officer of Smart Immune, said: “We are excited to present details from the ReSET-02 clinical study at ASH this year. Demonstrating the safety and efficacy of our lead asset SMART101 in the standard-of-care setting for haploidentical transplant is critical. The Haplo PTCy setting is increasingly used in the EU and the US, as donors are family members and therefore easier to find. However, the delayed Tcell reconstitution observed in patients puts them at risk of infections and relapses. By expediting T cell reconstitution post-transplant, we expect to improve the overall clinical outcomes and increase the benefit/risk ratio of haploidentical transplant."