Smart Immune and CELLforCURE by SEQENS Partner to Industrialize SMART101 Clinical Batches Manufacturing
2024年12月3日 - 2:00PM
PRESS RELEASE | Paris, France – December 3, 2024
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.
About CELLforCURE and SEQENS:
CELLforCURE SAS (commercial name: CELLforCURE by
SEQENS) is a CDMO authorized by ANSM, dedicated to ATMPs production
from concept to commercialization. With advanced technologies,
extensive capabilities, and large scale capacity, CELLforCURE
offers a seamless journey from early-stage development to
commercial manufacturing of a wide range of cell therapies.
CELLforCURE is part of the SEQENS Group, a
global partner in health, personal care and specialty ingredients,
leveraging 3300 employees, 16 manufacturing sites and 9 R&D
centers in 9 countries.
press@seqens.com / www.seqens.com / LinkedIn: SEQENS and
CELLforCURE by SEQENS
About Smart Immune:
Smart Immune is a clinical-stage biotechnology
company developing ProTcell, a thymus-empowered T-cell progenitor
platform to rapidly re-arm the immune system against cancer and
infection. The company aims to radically improve outcomes for
patients in hematology and immuno-oncology. Its main asset SMART101
is in Phase I/II trials for patients with acute leukemia or primary
immunodeficiencies (PID), in the EU and the US. Additional clinical
applications are planned to be evaluated in combination with
innovative cancer therapies.
lwormser@ulysse-communication.com (+33) 06 13 12 04 04 /
www.smart-immune.com / LinkedIn: Smart Immune