First Patient Dosed in Chemotherapy-Free Triple Combination Phase II Trial Targeting Soft Tissue Sarcoma
28 Julho 2023 - 9:00AM
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 first patient has been enrolled and safely dosed in
EFTISARC-NEO, the Phase II investigator-initiated trial of
eftilagimod alpha (efti), a soluble LAG-3 protein and MHC Class II
agonist, in combination with radiotherapy and the anti-PD-1 therapy
KEYTRUDA® (pembrolizumab) for patients with soft tissue sarcoma.
This chemo-free trial is the first to evaluate efti in a
neoadjuvant setting.
Soft tissue sarcoma (STS), an orphan disease,
represents a high unmet medical need with a poor prognosis. The
incidence of STS varies in different regions, with approximately
23,400 cases annually and a crude incidence of 4.7 per 100,000 in
Europe, according to the RARECARE project. In the United States,
the number of new cases is estimated to be 13,400 annually with
5,140 deaths, according to the American Cancer Society.
The open-label EFTISARC-NEO Phase II study,
which will treat up to 40 patients, is being conducted by the Maria
Skłodowska-Curie National Research Institute of Oncology (MSCNRIO)
and is primarily funded with an approved grant from the Polish
government awarded by the Polish Medical Research Agency program.
The trial’s Principal Investigators are Dr. Katarzyna Kozak, M.D.,
Ph.D., and Paweł Sobczuk, M.D., Ph.D., medical oncologists at the
Department of Soft Tissue/Bone Sarcoma and Melanoma at MSCNRIO.
Dr. Paweł Sobczuk stated: “Soft tissue sarcoma
is a rare, aggressive disease in high need of new therapeutic
approaches, and we are pleased to begin treating patients with this
novel IO-IO-radiotherapy combination and look forward to evaluating
the potential synergistic effects of this chemo-free therapy. In
particular, efti's sustained activation of antigen-presenting
cells, leading to proliferation of activated CD8+ T cells and
elevated interferon-gamma levels, may transform the
immunosuppressed tumour microenvironment of soft tissue sarcomas
into one that enables immune checkpoint inhibitors like
pembrolizumab to exert their anti-cancer effect. Additionally, we
see synergies between efti and radiotherapy to arm, activate, and
proliferate cytotoxic T cells with radiotherapy-induced cancer
antigens to target this difficult-to-treat tumour."
Immutep CSO, Frédéric Triebel, M.D., Ph.D, said:
“We are pleased to see this trial, led by the expert team at the
Maria Skłodowska-Curie National Research Institute, begin to enrol
and dose patients. EFTISARC-NEO represents the first time efti will
be evaluated in the neoadjuvant, non-metastatic cancer setting
where patients will receive efti much earlier on in their cancer
journey. Also, the neoadjuvant setting gives us the opportunity to
assess in the surgical specimen the changes in the tumour
microenvironment induced by efti. New information arising from this
innovative trial may further broaden the future clinical
development of efti and, in the end, bring even greater benefit to
patients.”
About Eftilagimod Alpha
(Efti)Efti is Immutep’s proprietary soluble LAG-3 clinical
stage candidate that is a first-in-class antigen presenting cell
(APC) activator that stimulates both innate and adaptive immunity
for the treatment of cancer. Efti binds to MHC II molecules on APCs
leading to activation/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 The Maria
Skłodowska-Curie National Research
Institute of OncologyThe Maria Skłodowska Curie National
Research Institute of Oncology is the leading Polish comprehensive
cancer centre, as well as the primary government research
institution devoted solely to oncology. Founded in 1932 by Maria
Sklodowska-Curie, it is currently divided into 28 specialised
clinical departments responsible for the diagnostics and therapy of
different tumour types such as: Breast Cancer Clinic, Head and Neck
Cancer Clinic, General and Visceral Surgery, Thoracic Surgery,
Urology, Gynaecology, Haematology, Soft Tissue/Bone Sarcoma and
Melanoma Clinic, Radiation Oncology, Brachytherapy and Diagnostic
Radiology, Pathology and Molecular Medicine and Cell Research,
Oncology, Gastroenterology, Cancer Epidemiology and Prevention
Division and others.
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. Media:Chris Basta, VP,
Investor Relations and Corporate Communications+1 (631) 318 4000;
chris.basta@immutep.com
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