Immutep Receives Positive Feedback from FDA on Late-Stage Clinical Development of Eftilagimod Alpha in Non-Small Cell Lung Cancer
16 Maio 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 it has received positive feedback from the US Food and
Drug Administration (FDA), regarding the Company’s late-stage
clinical development plans for its first-in-class soluble LAG-3
protein and MHC Class II agonist, eftilagimod alpha (“efti”), for
the treatment of 1st line non-small cell lung cancer (NSCLC).
The FDA is supportive of a registrational trial
to evaluate efti in combination with an anti-PD-1 therapy based on
the encouraging data from the Phase II TACTI-002, Part A (N=114) in
1st line NSCLC patients, no matter their level of PD-L1 expression,
presented in a late-breaking oral abstract presentation at the 37th
Annual Society of Immunotherapy of Cancer (SITC) Meeting in
November 2022.
Among the items discussed at the meeting were
the toxicological package and general aspects of the trial design,
including statistics and potential patient population with a focus
on 1st line NSCLC patients with a Tumor Proportion Score (TPS)
PD-L1 of >1% for which efti plus pembrolizumab has already
received Fast Track designation. This trial will be named TACTI-004
(Two ACTive
Immunotherapies).
Immutep CEO, Marc
Voigt,
commented: “In light of our
compelling clinical data that efti has generated in combination
with anti-PD-1 therapy, this meeting with the FDA is a critical
step in our late-stage development process for 1st line non-small
cell lung cancer. We are thankful for the positive feedback as we
continue moving forward with our unique immuno-oncology approach
for the many cancer patients impacted by this difficult
disease.”
Immutep CSO, Dr.
Frédéric Triebel, stated: “We are
very pleased with our constructive dialogue with the FDA
establishing a clear path forward for efti in front line non-small
cell lung cancer. These interactions represent an important
milestone within Immutep’s three main clinical programs targeting
cancers that affect large patient populations, positioning efti to
make a significant impact for the many patients in need of more
effective, tolerable, and durable immunotherapy.”
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 HER2–/HR+ 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 leading the development of
LAG-3 related immunotherapy products for the treatment of cancer
and autoimmune disease. The Company is dedicated to leveraging its
technology and expertise to bring innovative treatment options to
market for patients and to maximise value to shareholders.
Immutep’s lead product candidate is eftilagimod
alpha (“efti” or “IMP321”), a soluble LAG-3 fusion protein
(LAG-3Ig), which is a first-in-class antigen presenting cell (APC)
activator being explored in cancer in multiple clinical trials. The
Company is also developing an agonist of LAG-3 (IMP761) for
autoimmune disease. Additional LAG-3 product candidates, including
antibodies for immune response modulation, are licensed to and
being developed by Immutep’s large pharmaceutical partners.
Further information can be found on the
Company’s website www.immutep.com or by contacting:
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
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