Commercial Manufacturing of Eftilagimod Alpha at 2000L Scale Granted Authorization for Clinical Trial Use
21 Septiembre 2023 - 7:00AM
Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the
Company”), a clinical-stage biotechnology company developing novel
LAG-3 immunotherapies for cancer and autoimmune disease, today
announces the regulatory authorization of eftilagimod alpha
(“efti”) manufactured at commercial 2,000L scale for use in
clinical trials across multiple European countries including
Germany, Belgium, Denmark, and the United Kingdom.
After successfully scaling up the manufacturing
process of efti to commercial scale at WuXi Biologics, the
process-related changes were presented in a substantial amendment
of the Investigational Medicinal Product Dossier (IMPD). Overall
comparability of the first 2,000L and the previous 200L scale
clinical stage manufacturing process was achieved. Immutep plans to
introduce efti manufactured by the 2,000L scale process into
current and future clinical trials.
Marc Voigt, CEO of
Immutep, said: “With
late-stage clinical development underway for our first-in-class
soluble LAG-3 protein and MHC Class II agonist in non-small cell
lung cancer, head and neck cancer, and metastatic breast cancer,
commercial scale manufacturing of efti for use in clinical trials
is a significant achievement and brings us closer to realizing
efti’s potential to help cancer patients worldwide”.
About Eftilagimod
Alpha
(Efti)Efti is Immutep’s proprietary soluble LAG-3
protein and MHC Class II agonist that stimulates both innate and
adaptive immunity for the treatment of cancer. As a first-in-class
antigen presenting cell (APC) activator, efti binds to MHC (major
histocompatibility complex) Class II molecules on APC leading to
activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper
T cells, dendritic cells, NK cells, and monocytes. It also
upregulates the expression of key biological molecules like IFN-ƴ
and CXCL10 that further boost the immune system’s ability to fight
cancer.
Efti is under evaluation for a variety of solid
tumours including non-small cell lung cancer (NSCLC), head and neck
squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its
favourable safety profile enables various combinations, including
with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has
received Fast Track Designation in 1st line HNSCC and in 1st line
NSCLC from the United States Food and Drug Administration
(FDA).
About ImmutepImmutep is a
clinical-stage biotechnology company developing novel LAG-3
immunotherapy for cancer and autoimmune disease. We are pioneers in
the understanding and advancement of therapeutics related to
Lymphocyte Activation Gene-3 (LAG-3), and our diversified product
portfolio harnesses its unique ability to stimulate or suppress the
immune response. Immutep is dedicated to leveraging its expertise
to bring innovative treatment options to patients in need and to
maximise value for shareholders. For more information, please visit
www.immutep.com.
Australian Investors/Media:Catherine Strong,
Citadel-MAGNUS+61 (0)406 759 268; cstrong@citadelmagnus.com
U.S.
Investors/Media:Chris Basta, VP,
Investor Relations and Corporate Communications+1 (631) 318 4000;
chris.basta@immutep.com
Immutep (NASDAQ:IMMP)
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