Smart Immune, a clinical-stage biotechnology company, and CELLforCURE by SEQENS, a Contract  Development and Manufacturing Organization (CDMO) for Advanced Therapy Medical Products (ATMPs),  announced today a strategic collaboration to expand SMART101 production capabilities. SMART101 is an  innovative therapy in Phase I/II trials for patients with acute leukemia or primary immunodeficiencies (PID),  in the EU and the US. 

Enhanced Production Capacity  

This partnership will complement Smart Immune's existing capabilities at the MEARY Center for Cell and  Gene Therapy and Necker Children Hospital in Paris, supporting the company's expanding clinical  development with patients’ inclusions expected to rapidly increase in 2025. 

The collaboration will enable the production of SMART101 for the ReSET trials in primary immune  deficiencies and hematological malignancies post-transplant, as well as for new proof-of-concept trials in  solid tumors. CELLforCURE brings a robust and strongly established commercial manufacturing experience, positioning itself as a highly reliable partner for Smart Immune at a critical development stage of its ProTcell  platform. 

Manufacturing Process Evolution 

As part of this collaboration, the technology transfer will involve an intermediate manufacturing process,  currently being set up at the MEARY Centre, which will bridge the gap between current clinical production  methods and future fully automated steps.  

This evolution includes cell selection, scale-up aligned with future v2.0 requirements, and semi-automation  of key steps like the implementation of mini-bioreactor-based production. 

Accelerating Patient Access 

"This collaboration marks a significant step in our mission to bring innovative cell therapies to more  patients," says Karine Rossignol, Co-Founder and Chief Executive Officer of Smart Immune. "By partnering  with CELLforCURE, we're establishing a robust manufacturing framework to support our growing clinical  programs and future commercialization needs.” 

“We are very proud to collaborate with Smart Immune and contribute to the ambition of bringing innovative  cell therapies to more patients,” says Pierre-Noël Lirsac, President of CELLforCURE. “CELLforCURE will  leverage its historical expertise as a CDMO as well as its “real-life” experience to manufacture SMART101 clinical batches.” 

Pierre Heimendinger, Chief Technical Officer of Smart Immune, adds: "The enhanced manufacturing  process, featuring rapid sterility testing, will enable a vein-to-vein time of just two weeks. This is particularly 

crucial for patients receiving fresh allogeneic hematopoietic stem cell transplants within the European and  Middle Eastern zones." 

Strategic Choice of European Manufacturing 

The choice of CELLforCURE, with its established track record in commercial cell therapy manufacturing,  aligns with Smart Immune's commitment to maintaining production excellence in France and Europe. This  decision builds upon the foundation established with the MEARY Center at Saint-Louis Hospital and Necker  Children Hospital, reflecting the company's dedication to leveraging French and European expertise in  advanced therapy manufacturing. 

A commitment also shared by the SEQENS Group, who capitalized and invested in France and Europe to  maintain and develop essential and strategic capabilities for the healthcare sector.