Full Press Release Details
Immutep Receives FDA Fast Track Designation for LAG-3 Therapeutic
Eftilagimod Alpha for First Line Non-Small Cell Lung Cancer
SYDNEY, AUSTRALIA 4 October 2022 Immutep Limited (ASX:
IMM; NASDAQ: IMMP) ( Immutep or the Company ), a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease, today announced the United States Food and Drug Administration (FDA) has
granted Fast Track designation to eftilagimod alpha ( efti or IMP321 ) in combination with pembrolizumab for the treatment of 1st line
non-small cell lung cancer (NSCLC). Efti is the Company s first-in-class soluble
LAG-3 clinical stage candidate which activates antigen presenting cells (APC) to engage both the innate and adaptive immune system to target solid tumors.
We are pleased to receive this Fast Track designation as it acknowledges efti s unique potential to empower the human immune system against cancer
and significantly enhance patient responses to standard-of-care immunotherapy. Efti also offers a chemotherapy-free option for NSCLC patients in need of less toxic and
more durable solutions, stated Marc Voigt, CEO of Immutep.
This important designation that efti has now received across two indications, 1st line NSCLC and 1st line HNSCC, enables us to work more closely with the FDA to bring this novel treatment option to cancer patients in the most
timely and efficient manner possible. We look forward to providing additional clinical data in 1st line NSCLC later this year, he concluded.
The FDA s Fast Track designation process is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions
and fill an unmet medical need. Immutep will now have access to more frequent interactions with the FDA to discuss efti s development path and, if relevant criteria are met, eligibility for Rolling Review, Accelerated Approval, and Priority
Fast Track designation has been granted for the development of efti in combination with pembrolizumab in 1st line treatment of Stage IIIB/IV NSCLC patients expressing PD-L1 Tumor Proportion Score 1%, not amenable to EGFR/ALK based therapy. The designation is
based on the encouraging TACTI-002/KEYNOTE-798 Phase II clinical data in 1st line NSCLC for PD-L1 all-comers shared earlier this year via an oral presentation at the American
Society of Clinical Oncology s (ASCO) 2022 Annual Meeting.
This represents the second Fast Track designation that efti has received,
following receipt of the same designation in April 2021 for efti in combination with pembrolizumab in 1st line treatment of recurrent or metastatic Head and
Neck Squamous Cell Carcinoma.
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 for the treatment of cancer, in particular solid tumors. Efti capitalises on LAG3 s unique characteristics to activate both innate and adaptive
immunity via binding to antigen presenting cells such as dendritic cells, monocytes, and macrophages via MHC II molecules. Activation of APCs leads to expansion of anti-tumor cells, presentation of antigens to the adaptive immune system, and
proliferation of CD4+ (helper) and CD8+ (cytotoxic) T cells. Efti s favorable safety profile enables its use in various combination settings, including with
anti-PD-[L]1 immunotherapy and/or chemotherapy.
Efti is under evaluation
for a variety of solid tumors including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and HER2 /HR+ metastatic breast cancer. Efti has received Fast Track Designation
in 1st line recurrent or metastatic HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).
Immutep 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. Immutep 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.
Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United
Further information can be found on the Company s website www.immutep.com or by contacting:
Australian Investors/Media:
+61 (0)406 759 268; cstrong@citadelmagnus.com
Tim McCarthy, LifeSci Advisors
+1 (917) 679 9282; tim@lifesciadvisors.com
announcement was authorised for release by the Board of Immutep Limited.
Immutep Limited, Level 33, Australia Square
264 George Street, Sydney NSW 2000