MolMed and Miltenyi Biotec: EMA approves the utilization of the CliniMACS Prodigy® equipment in the commercial manufacturing process of Zalmoxis®, a patient-specific cell therapy for the treatment of adult patients affected by leukemia and other high-risk hematological malignancies.
Milan (Italy) – Bergisch Gladbach (Germany), February, 26th 2018 – MolMed
S.p.A. (MLMD.MI) a medical biotechnology company focusing on research,
development, manufacturing, and clinical validation of innovative therapies
to treat cancer, and Miltenyi Biotec GmbH, a global supplier of equipment
and services for cell and gene therapy, announce that the European
Medicines Agency (EMA) has approved the utilization of the CliniMACS
Prodigy®, a closed environment, automated cell production device developed
by Miltenyi Biotec, in the GMP manufacturing of Zalmoxis®.
With the positive outcome of the request submitted by MolMed to EMA,
CliniMACS Prodigy® for the first time, becomes part of a manufacturing
process for a commercial drug, namely Zalmoxis®, which has been authorized
for marketing in Europe.
Zalmoxis®, MolMed patient-specific cell therapy, is based on engineering of
the donor immune system, in combination with haplo-identical haematopoietic
stem cell transplant (haplo-HSCT) for the treatment of leukemia at
high-risk of relapse. This therapy is part of the immuno-oncology field
that uses modified T-cells to maximize the antitumor effect of the immune
system, and is considered one of the most promising frontiers in the
treatment of patients suffering from malignancies refractory to
Zalmoxis® was approved for commercial use by the European Community in 2016
and is reimbursable in Germany and also, from March 1st, in Italy.
The CliniMACS Prodigy® System, developed and distributed by Miltenyi
Biotec, is today the only instrument in the world able to offer integrated
solutions that standardize cell engineering in a completely automated
process. The CliniMACS Prodigy® guarantees maximum efficiency in compliance
with in-process control (IPC) and quality control (QC), both fundamental
requirements for reliable cell manufacturing.
With the CliniMACS Prodigy® instrument in its GMP facility, MolMed is able
to optimize the efficiency of the Zalmoxis® manufacturing cycle, in terms
of doses obtained from a single production cycle, and to reduce the number
of open handling steps, ensuring a reproducibly high-quality standard.
Riccardo Palmisano, CEO of MolMed, commented: "
The use of a cutting-edge production technology such as the CliniMACS
confirms the qualitative excellence that differentiates MolMed in the
manufacture of gene and cell therapies. By supporting the provision of
a drug on the market, it enhances our potential in ensuring the
for all the patients prescribed with it. Our GMP facility will in fact
produce the doses necessary for treatments in a more efficient way,
while improving the quality and reliability of the process and
providing a better service for the patient
, Miltenyi Biotec CEO, commented: “
The EMA approval is an important step for us. This is the first time
that a commercial product has been approved for production on our
ground-breaking cell processing platform, the ClinicMACS Prodigy®.
Together with our partner MolMed, we have come a long way from using
our device in numerous clinical trials all over the world to using it
in a commercial manufacturing process that requires a whole new level
of standardization, reproducibility, and production volume. We are
proud that by utilizing our technology, MolMed is able to enhance the
quality and reliability of their novel cell therapy
MolMed S.p.A. is a biotechnology company focused on research, development,
manufacturing and clinical validation of innovative anticancer therapies.
MolMed's product portfolio includes proprietary anti-tumor therapies in
clinical and preclinical development: Zalmoxis® (TK) is a cell therapy
based on donor T cells genetically engineered to enable bone marrow
transplants from partially compatible donors for patients with high-risk
hematological malignancies, eliminating post-transplant immunosuppression
prophylaxis and inducing a rapid immune reconstitution. Zalmoxis® received
Orphan Drug Designation and is currently in Phase III in a high-risk
population of acute leukemia patients, but has already obtained a
Conditional Marketing Authorization by the European Commission in the
second half of 2016 as well as reimbursement conditions in Italy at the end
of 2017 and in Germany at the beginning of 2018. Still focusing on this
cell & gene technology, the company is developing a therapy based on
Chimeric Antigen Receptor (CAR), specifically the CAR-T CD44v6, an immune
gene therapy project, currently in advanced preclinical development,
potentially effective for hematological malignancies and several solid
epithelial tumors. MolMed is also the first company in Europe to have
obtained the GMP manufacturing authorization for cell & gene therapies
for its proprietary products (Zalmoxis®) as well as for third parties
and/or in partnership (Strimvelis, a GSK gene therapy for the ADA-SCID).
With reference to GMP development and manufacturing activities for third
parties, MolMed signed numerous partnership agreements with leading
European and US companies. In the framework of innovative anticancer
therapies, MolMed’s pipeline also includes NGR-hTNF, a therapeutic agent
for solid tumors investigated in a broad clinical program, involving more
than 1,000 treated patients. MolMed, founded in 1996 as an academic
spin-off of the San Raffaele Scientific Institute, is listed on the main
market (MTA) of the Milan stock exchange managed by Borsa Italiana since
March 2008. MolMed is headquartered and based in Milan, at the San Raffaele
Biotechnology Department (DIBIT) and has an operating unit at OpenZone in
About Miltenyi Biotec
Miltenyi Biotec’s global team of over 2,000 employees design, develop,
manufacture, and market products that help advance biomedical research and
enable cell and gene therapy programs.
With headquarters in Bergisch Gladbach, Germany and dedicated manufacturing
facilities in Germany and the US, we supply the world with flow cytometry
analyzers and sorters, instrumentation for clinical applications, cell
culture devices, reagents, and cell separation technologies.
GMP-grade suites for in-house and contracted manufacturing of cell products
and lentiviral vectors are integral parts of our European and North
Miltenyi Biotec’s engineers, scientists, clinicians, and support teams are
all dedicated to helping improve human lives. It is their know-how that is
at the root of our product innovation, long-term growth, and worldwide
For further information:
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