Smart Immune and Greater Paris University Hospitals (AP-HP) begin groundbreaking Phase I/II trial with ProTcellTM, a thymus-empowered T-cell therapy…

Smart Immune

Smart Immune and Greater Paris University Hospitals (AP-HP) begin groundbreaking Phase I/II trial with ProTcellTM, a thymus-empowered T-cell therapy platform, in adults with blood cancers

First trial to inject T cell progenitor cells derived from cord blood using Smart Immunes ProTcellTM platform

PARIS, France, October 13, 2022 Smart Immune SAS, a clinical-stage biotechnology company developing ProTcell, a thymus-empowered T-cell therapy platform to fully and rapidly re-arm the immune system, and the Greater Paris University Hospitals (AP-HP), announced today that SMART102, a human T-lymphoid progenitor cell injection derived from cord blood using Smart Immunes ProTcell platform, has entered clinical testing in a trial sponsored and led by Great Paris University Hospitals (AP-HP).

The multicenter Phase I/II trial (NCT04707300) is a proof-of-concept, dose escalation, 10-patient study that will evaluate safety and efficacy of SMART102 to accelerate immune reconstitution after allogeneic hematopoietic stem cell transplantation (HSCT) in adult patients with hematological malignancies. SMART102 is an injection into the patient of allogeneic T-cell progenitors produced by Smart Immunes ProTcell platform designed to travel to the patients thymus and become differentiated into fully functional T-cells.

The trial has been designed to assess the potential of the ProTcell technology to improve clinical outcomes of HSCT. Overall survival in this patient group is currently low at 5 years post-HSCT, with around 50% mortality1.

No safety-related issues or dose limiting toxicity have been reported in the first patient enrolled in the trial to date. Preliminary data from the trial are expected in around 18 months.

Karine Rossignol, PharmD, Co-founder and Chief Executive Officer of Smart Immune, said: This trial follows the pioneering work of our co-founders Professor Marina Cavazzana and Dr Isabelle Andr and their teams at Necker Children Hospital, AP-HP and the Imagine Institute. Smart Immune can develop large numbers of T-cell progenitors from hematopoietic stem cells in one week ex vivo, which the thymus educates to become the full repertoire of immune cells in around three months, compared with 15-18 months through bone marrow transplantation alone. This significantly reduces the time to full immune recovery and potentially provides a transformational shift in the benefit/risk ratio of allogeneic T-cell medicine.

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Professor Olivier Hermine, MD, PhD, Head of Hematology at Necker Children Hospital, AP-HP, and Principal Investigator of the study, said: Immune reconstitution post allo HSCT remains a huge unmet medical need. Faster, polyclonal T-cell recovery after transplantation will be key to improving clinical outcomes and survival. No therapy to date allows it. We are excited to start addressing it in this first-time-in oncology human trial by using ProTcellTM from cord blood in combination with unmanipulated cord blood stem cells of a different source.

Double cord-blood approach

Umbilical cord blood (UCB) grafts are frequently used for patients lacking an HLA-matched family donor and in the absence of an appropriate unrelated donor. As with any HSCT, UCB transplantations are associated with the risk of acute and chronic GVHD (graft versus host disease), post-transplant immunodeficiency with increased risk of infections, as well as relapse. These risks have been linked to a delay in immune reconstitution, and the longer a patient remains without a fully functional immune system, the greater the risks.

This Phase I/II trial protocol utilizes two umbilical cord blood units for each patient. One remains unmanipulated and is grafted into the patient on Day 0 as standard allogeneic cord blood transplantation. On the same day, the patient also receives an injection of SMART102 T-cell progenitor cells, derived from the second unit of cord blood using ProTcellTM technology.

The aim is to induce faster T-cell reconstitution through ProTcellTM technology and improve clinical outcomes for this patient population.

The ProTcell platform aims to accelerate the production of tolerized, allogeneic, polyclonal naive T-cells by the patients own thymus through infusion of clinical-grade, allogeneic early lymphoid progenitor cells generated in seven days ex-vivo. Preclinical data suggest that the ProTcellTM platform may reconstitute the immune system in 100 days instead of the 12 to 18 months observed in physiology.

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About Assistance Publique - Hpitaux de Paris/Greater Paris University Hospitals

The leading hospital and university centre (CHU) in Europe, Greater Paris University Hospitals and its 38 hospitals are organised into six hospital-university groups (AP-HP. Centre - Universit Paris Cit ; AP-HP. Sorbonne Universit ; AP-HP. Nord - Universit Paris Cit ; AP-HP. Universit Paris Saclay ; AP-HP. Hpitaux Universitaires Henri Mondor et AP-HP. Hpitaux Universitaires Paris Seine-Saint-Denis) and are centered around five universities in the le-de-France region. Closely linked to large research bodies, Greater Paris University Hospitals include four international hospital-university institutes (Institut du Cerveau, ICAN, IMAGINE, FOReSIGHT) and the largest French health data repository (EDS). As a major stakeholder in applied research and health innovation, Greater Paris University Hospitals hold a portfolio of 650 active patents, and each year its clinicians sign off nearly 10000 scientific publications and over 4,000 research projects areunderdevelopment, all promoters combined. In 2020, Greater Paris University Hospitals were awarded the Institut Carnot label, which is recognition of the quality of partnerresearch: Carnot@AP-HPoffers industrial stakeholders applied and clinical research solutions in the health sector. In 2015, Greater Paris University Hospitals also founded the Greater Paris University Hospitals Research Foundation to support the biomedical and health research performed in all its hospitals.http://www.aphp.fr

About Smart Immune

Smart Immune is a clinical-stage biotechnology company developing ProTcell, a thymus-empowered T-cell therapy platform to fully and rapidly re-arm the immune system, enabling next-generation allogeneic T-cell therapies for all. The company was founded in 2017 to help patients with life-threatening diseases such as high-risk blood cancers and primary immunodeficiencies.

Smart Immunes ProTcell platform, which is already in Phase I/II clinical trials, enables the recovery of a complete immune repertoire in patients fighting cancer and infection. ProTcell introduces potent, allogeneic T-cell progenitors which are then differentiated by the thymus into fully functional T-cells an off the shelf T-cell medicine.

Smart Immunes partners include Memorial Sloan Kettering in New York and Greater Paris University Hospitals (AP-HP). The company is headquartered at Paris Biotech Sant, 29 rue du Faubourg St Jacques, France.

https://www.smart-immune.com/

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1 https://www.nature.com/articles/s41409-019-0624-z/tables/2

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Smart Immune and Greater Paris University Hospitals (AP-HP) begin groundbreaking Phase I/II trial with ProTcellTM, a thymus-empowered T-cell therapy...