Sensible Immune and CELLforCURE by SEQENS Companion to Industrialize SMART101 Medical Batches Manufacturing

PRESS RELEASE | Paris, France – December 3, 2024

Sensible Immune, a clinical-stage biotechnology firm, and CELLforCURE by SEQENS, a Contract Improvement and Manufacturing Group (CDMO) for Superior Remedy Medical Merchandise (ATMPs), introduced in the present day a strategic collaboration to broaden SMART101 manufacturing capabilities. SMART101 is an progressive remedy in Section I/II trials for sufferers with acute leukemia or main immunodeficiencies (PID), within the EU and the US.

Enhanced Manufacturing Capability

This partnership will complement Sensible Immune’s current capabilities on the MEARY Heart for Cell and Gene Remedy and Necker Kids Hospital in Paris, supporting the corporate’s increasing medical growth with sufferers’ inclusions anticipated to quickly improve in 2025.
The collaboration will allow the manufacturing of SMART101 for the ReSET trials in main immune deficiencies and hematological malignancies post-transplant, in addition to for brand spanking new proof-of-concept trials in stable tumors. CELLforCURE brings a sturdy and strongly established industrial manufacturing expertise, positioning itself as a extremely dependable accomplice for Sensible Immune at a crucial growth stage of its ProTcell platform.

Manufacturing Course of Evolution

As a part of this collaboration, the expertise switch will contain an intermediate manufacturing course of, presently being arrange on the MEARY Centre, which can bridge the hole between present medical manufacturing strategies and future totally automated steps.

This evolution contains cell choice, scale-up aligned with future v2.0 necessities, and semi-automation of key steps just like the implementation of mini-bioreactor-based manufacturing.

Accelerating Affected person Entry

“This collaboration marks a major step in our mission to deliver progressive cell therapies to extra sufferers,” says Karine Rossignol, Co-Founder and Chief Govt Officer of Sensible Immune. “By partnering with CELLforCURE, we’re establishing a sturdy manufacturing framework to assist our rising medical packages and future commercialization wants.”

“We’re very proud to collaborate with Sensible Immune and contribute to the ambition of bringing progressive cell therapies to extra sufferers,” says Pierre-Noël Lirsac, President of CELLforCURE. “CELLforCURE will leverage its historic experience as a CDMO in addition to its “real-life” expertise to fabricate SMART101 medical batches.”

Pierre Heimendinger, Chief Technical Officer of Sensible Immune, provides: “The improved manufacturing course of, that includes fast sterility testing, will allow a vein-to-vein time of simply two weeks. That is notably essential for sufferers receiving recent allogeneic hematopoietic stem cell transplants throughout the European and Center Jap zones.”

Strategic Alternative of European Manufacturing

The selection of CELLforCURE, with its established observe report in industrial cell remedy manufacturing, aligns with Sensible Immune’s dedication to sustaining manufacturing excellence in France and Europe. This resolution builds upon the muse established with the MEARY Heart at Saint-Louis Hospital and Necker Kids Hospital, reflecting the corporate’s dedication to leveraging French and European experience in superior remedy manufacturing.

A dedication additionally shared by the SEQENS Group, who capitalized and invested in France and Europe to take care of and develop important and strategic capabilities for the healthcare sector.

About CELLforCURE and SEQENS:

CELLforCURE SAS (industrial identify: CELLforCURE by SEQENS) is a CDMO licensed by ANSM, devoted to ATMPs manufacturing from idea to commercialization. With superior applied sciences, in depth capabilities, and huge scale capability, CELLforCURE provides a seamless journey from early-stage growth to industrial manufacturing of a variety of cell therapies.

CELLforCURE is a part of the SEQENS Group, a worldwide accomplice in well being, private care and specialty elements, leveraging 3300 workers, 16 manufacturing websites and 9 R&D facilities in 9 international locations.

[email protected] / www.seqens.com / LinkedIn: SEQENS and CELLforCURE by SEQENS

About Sensible Immune:

Sensible Immune is a clinical-stage biotechnology firm growing ProTcell, a thymus-empowered T-cell progenitor platform to quickly re-arm the immune system in opposition to most cancers and an infection. The corporate goals to radically enhance outcomes for sufferers in hematology and immuno-oncology. Its primary asset SMART101 is in Section I/II trials for sufferers with acute leukemia or main immunodeficiencies (PID), within the EU and the US. Further medical purposes are deliberate to be evaluated together with progressive most cancers therapies.

[email protected] (+33) 06 13 12 04 04 /  www.smart-immune.com / LinkedIn: Smart Immune