Immutep Announces Completion of the Safety Lead-In and Opening of the Randomized Phase II of the AIPAC-003 Phase II/III Trial in Metastatic Breast Cancer
06 Novembre 2023 - 2:00PM
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 open-label safety lead-in of its integrated AIPAC-003
Phase II/III trial evaluating for the very first time 90mg of
eftilagimod alpha (efti) in combination with paclitaxel has been
completed with no safety or tolerability issues.
Six patients with metastatic breast cancer
receiving this immuno-oncology chemotherapy (IO-chemo) combination,
after exhaustion of all endocrine/CDK4/6 based therapies, tolerated
the therapy very well and there were no dose limiting toxicities,
as confirmed by the independent Data Monitoring Committee (IDMC)
appointed for the trial. The IDMC recommended proceeding to the
randomised Phase II portion of the trial.
The randomised (1:1) Phase II portion of the
study will now open to include up to 58 evaluable patients with
metastatic breast cancer receiving either 30mg efti or 90mg efti to
determine the optimal biological dose. The evaluation of 90mg efti
dosing in combination with paclitaxel is driven by efti’s excellent
safety profile, along with the FDA’s Project Optimus initiative in
oncology. Importantly the determination of the optimal biological
dose is relevant for the whole efti program across all disease
indications.
The integrated Phase II/III AIPAC-003 trial is
evaluating efti, Immutep’s soluble LAG-3 protein and first-in-class
MHC Class II agonist, in combination with standard-of-care
paclitaxel for the treatment of metastatic hormone receptor
positive (HR+), HER2-negative or HER2-low breast cancer
and triple-negative breast cancer. It will take place at
approximately 17 clinical sites across Europe and the United States
of America. For more information on the trial, please visit
clinicaltrials.gov (NCT05747794).
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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