Immutep Receives Approval to Initiate INSIGHT-005 Trial Evaluating Eftilagimod Alpha and Anti-PD-L1 Therapy BAVENCIO®
01 Maio 2023 - 9:00AM
Immutep Limited (ASX: IMM; NASDAQ: IMMP), a clinical-stage
biotechnology company developing novel LAG-3 immunotherapies for
cancer and autoimmune disease, today announces it has received
regulatory approval from the Paul-Ehrlich-Institut (“PEI”), German
Federal Institute for Vaccines and Biomedicines, to initiate
INSIGHT-005, an investigator-initiated, open-label Phase I trial
evaluating the safety and efficacy of eftilagimod alpha (“efti”) in
combination with BAVENCIO® (avelumab) in up to 30 patients with
metastatic urothelial carcinoma.
Urothelial carcinoma is the most common type of
bladder cancer. For 2023, it is estimated there will be 82,290 new
cases of bladder cancer and 16,710 deaths in the US alone.1
Patients not eligible for platinum-based chemotherapy or
progressing during or after platinum-based chemotherapy represent
an area of high unmet need and will be enrolled in the trial.
“We are excited to get this important trial
underway. In addition to possibly bringing a new chemo-free
treatment option to patients with advanced urothelial cancer, we
hope to further build upon the encouraging clinical data we have
seen to date combining efti and avelumab in other challenging
cancers. Efti’s unique activation of antigen-presenting cells to
fight cancer has shown a benefit with avelumab, and we believe this
dual IO-IO approach has broad potential to drive superior clinical
outcomes across a variety of indications, including bladder cancer
where avelumab monotherapy has regulatory approval,” said Immutep
CEO, Marc Voigt.
BAVENCIO® is a checkpoint inhibitor owned by
Merck KGaA, Darmstadt, Germany, that works by targeting and
blocking a protein called PD-L1 on the surface of cancer cells and
certain immune cells, activating the cells to find and kill cancer
cells. It is approved as a monotherapy for first-line maintenance
treatment for adult patients with advanced urothelial carcinoma
that has not progressed with first-line platinum-containing
chemotherapy in more than 60 countries around the world.
Efti, a soluble LAG-3 protein and novel MHC Class II agonist,
was previously evaluated in combination with BAVENCIO® in patients
with advanced solid tumours in the INSIGHT-004 Phase I trial.
Encouragingly, deep and durable responses were achieved in patients
with low or negative PD-L1 expression as well as immuno-oncology
insensitive tumours.
INSIGHT-005 will be conducted by the Institute
of Clinical Cancer Research IKF at Krankenhaus Nordwest in
Frankfurt as part of the investigator-initiated INSIGHT platform
for studies investigating efti in different combination treatments
and routes of administration. INSIGHT currently consists of 5
different arms from stratums A to E (INSIGHT-005 is Stratum E).
1 US National Cancer Institute:
https://seer.cancer.gov/statfacts/html/urinb.html
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
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