Revolutionary Cell Therapy Doses First US Leukemia Patient with Smart Immune’s SMART101 Treatment

Today, Smart Immune SAS, a clinical-stage biotechnology company, made an exciting announcement: the first adult leukemia patient has been successfully dosed with SMART101, a revolutionary T-cell progenitor cell injection derived from donor stem cells using the company’s ProTcell technology. This groundbreaking therapy, which has the potential to rapidly re-arm the patient’s immune system, was administered at Memorial Sloan Kettering Cancer Center (MSK). This is a major step forward in the fight against cancer.

This innovative Phase I/II clinical trial (NCT04959903) is a first-of-its-kind opportunity to explore the potential of SMART101 to improve clinical outcomes of hematopoietic stem cell transplantation (HSCT) in adult and pediatric patients with haematological malignancies. Up to 36 volunteers are invited to take part in this open-label, multicenter study, which promises to shed light on the safety profile of this cutting-edge treatment.

In December 2022, the first patient enrolled in the SMART101 trial received their injection – marking a significant milestone in the quest for a breakthrough medical treatment. So far, no adverse events have been reported.

The infusion of the first patient marks a remarkable milestone in Smart Immune’s journey to address the slow immune reconstitution following allogeneic HSCT with the help of the thymus. Chief Medical Officer of Smart Immune, Dr Frédéric Lehmann, expressed his gratitude to the dedicated investigators at MSK and expressed his anticipation of the continuation of the enrolment in the trial.

Karine Rossignol, Chief Executive Officer and Co-founder of Smart Immune, could not contain her excitement when announcing the groundbreaking trial the company is sponsoring. “Accelerated reconstitution of a full polyclonal T-cell repertoire after stem cell transplantation could improve both quality of life and clinical outcomes for patients with acute leukemia,” she said, “and we can’t wait to see the results of the trial and share them with the world.”

About SMART101

SMART101 is a revolutionary ex vivo T-cell therapy generated from allogeneic blood stem cells in just 7 days using Smart Immune’s ProTcell platform. Preclinical data suggests this platform could restore a patient’s immune system in a mere 100 days, rather than the usual 12-18 months. Developed in partnership with the MEARY Center for Cell and Gene Therapy at Paris St Louis Hospital (AP-HP), SMART101 is poised to be a game-changer in the fight against infection and relapse.

About Smart Immune

Smart Immune is at the forefront of revolutionizing healthcare with its ProTcell platform – a groundbreaking thymus-empowered T-cell therapy that promises to re-arm the immune system in a quick and efficient manner. Founded in 2017, this clinical-stage biotechnology company is already making waves, with its highly effective treatment of high-risk blood cancers and primary immunodeficiencies. With Smart Immune, the future of healthcare is here.

Smart Immune has developed its ProTcell platform to revolutionize the way in which patients fighting cancer and infection recover their complete immune repertoires. By introducing potent, allogeneic T-cell progenitors and allowing the thymus to differentiate them into fully functional T-cells, ProTcell provides an ‘off the shelf’ T-cell medicine that is already undergoing Phase I/II clinical trials.

Smart Immune, a leading innovator in the healthcare sector, is proud to partner with world-renowned institutions Memorial Sloan Kettering Cancer Center in New York and Greater Paris University Hospitals (AP-HP). Located at Paris Biotech Santé, 29 rue du Faubourg St Jacques, France, Smart Immune is dedicated to developing cutting-edge solutions to better serve patients and healthcare professionals worldwide.

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