Breakthrough Moment: Smart Immune Administers Game-Changing SMART101 ProTcell Therapy to Leukemia Patients in Landmark ReSET-02 Phase I/II Trial

In a groundbreaking moment for medical science, Smart Immune, the clinical-stage biotechnology trailblazer, has marked a significant milestone. The first courageous patients have received doses of SMART101, a groundbreaking thymus-empowered T-cell progenitor therapy, in the game-changing ReSET-02 Phase I/II trial. This momentous event is a beacon of hope for adults battling acute leukemia and myelodysplasia syndrome.

SMART101, a marvel created from donor mobilized peripheral blood stem cells and transformed into T-cell progenitors via Smart Immune’s innovative ProTcell therapy platform, is already showing promise.

Early data indicate not only remarkable tolerability but also a safety profile mirroring that observed in patients enrolled in the ongoing ReSET-01 clinical trial in the T-cell-depleted allogeneic HSCT setting. The journey is far from over; more patients are poised to receive their doses in the coming weeks, with a total of 40 individuals set to be part of this groundbreaking trial.

ReSET-02 (NCT05768035) is not just another trial; it’s a beacon of hope for patients with hematological malignancies like acute lymphoid leukemia, acute myeloid leukemia, and myelodysplasia syndrome.

This open-label, multi-center Phase I/II study is designed to assess the safety and efficacy of SMART101 post-standard-of-care HSCT, armed with post-transplant cyclophosphamide. The ultimate goal? Accelerating T-cell reconstitution to combat relapse and infection, thereby enhancing overall and disease-free survival post-transplant.

But the implications reach far beyond oncology; Smart Immune’s ProTcell platform, if validated through the success of this trial, holds the potential to transform healthcare in areas such as HIV treatment.

It’s worth noting that SMART101 has been granted the prestigious Orphan Drug Designation (ODD) by both the European Medicines Agency and the US Food and Drug Administration (FDA). The FDA has also bestowed Fast Track Designation upon it as a treatment to enhance cell engraftment in HSCT patients. SMART101 is meticulously manufactured at the MEARY Center, AP-HP, in the vibrant city of Paris.

Karine Rossignol, the visionary Chief Executive Officer of Smart Immune, expressed her excitement: “Our goal is to show that we can quickly and fully re-arm the immune system to improve survival rates in difficult-to-treat cancers, harnessing the thymus to provide a new immune system in a few months.”

Frédéric Lehmann, the esteemed Chief Medical Officer of Smart Immune, added, “Based on our preclinical data, we believe our thymus-empowered allogeneic cell therapy has the potential to shift the treatment paradigm and improve clinical outcomes of allogeneic HSCT.”

This historic moment is a testament to the relentless dedication of participating patients, clinical sites, and the entire Smart Immune team, all united in their mission to change the face of medicine.

About Smart Immune

In the dynamic landscape of biotechnology, one company stands out as a true innovator: Smart Immune. Their mission? Nothing short of a revolution in healthcare. They’re pioneering ProTcell, an ingenious T-cell progenitor therapy platform infused with the power of the thymus, poised to re-arm the immune system swiftly and comprehensively.

The goal? To usher in a new era of allogeneic T-cell therapies that hold the promise of transformation for patients facing life-threatening diseases, from high-risk blood cancers to primary immunodeficiencies.

Smart Immune is not just a company; it’s a beacon of hope, with ongoing collaborations with esteemed institutions across the US and Europe. At the forefront of their quest is SMART101, a game-changing therapy now blazing a trail in Phase I/II clinical trials on both sides of the Atlantic. Its mission? To accelerate complete immune recovery in patients battling cancer and infection, all while undergoing allogeneic hematopoietic stem cell transplantation.

But that’s not where their story ends. Smart Immune is writing the future of medicine with therapies crafted from gene-modified T-cell progenitors, all made possible through the ProTcell platform. Imagine off-the-shelf CAR T-cells ready to take on cancer or HIV-resistant T-cells providing targeted treatments against AIDS. The possibilities are as limitless as their commitment to innovation.

With their headquarters nestled in the vibrant heart of Paris, France, at Paris Biotech Santé, Smart Immune is not just changing the rules of the game; they’re rewriting the narrative of healthcare itself.

About the ReSET-02 clinical trial

In a quest to rewrite the future of hematological malignancies, SMART101 takes center stage in the ReSET-02 Phase I/II trial. Picture this: a multi-center, open-label, dose-escalation study that dares to challenge the status quo, all in the name of patient well-being.

What’s the mission? To evaluate the safety and activity of SMART101 after haploidentical peripheral blood stem cell transplantation, complemented by post-transplant cyclophosphamide. This trial isn’t just another study; it’s a beacon of hope for those battling hematological malignancies.

As the trial advances, patients will be the stars of the show, enrolling in parallel into two cohorts based on the intensity of their conditioning chemotherapy. And the drama doesn’t stop there; the trial unfolds in two consecutive stages, a testament to meticulous planning and the pursuit of excellence, guided by Simon’s 2-stage design.

The stage is set, and the spotlight shines on multiple sites in France and Italy, where the future of hematological malignancy treatment is being shaped. ReSET-02 isn’t just a trial; it’s a testament to the power of innovation and the unwavering dedication to improving the lives of those in need.

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