Full Press Release Details
IMMUTEP ACHIEVES FAST TRACK DESIGNATION FROM US FDA
FOR EFTI, A SOLUBLE LAG-3 PROTEIN, IN FIRST LINE RECURRENT/METASTATIC HEAD & NECK CANCER
SYDNEY, AUSTRALIA 8 April 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ( Immutep or
the Company ), a biotechnology company developing novel immunotherapy treatments for cancer, infectious disease and autoimmune disease, announces its lead product candidate eftilagimod alpha ( efti or IMP321 ), a
soluble LAG-3 protein, has received Fast Track designation in 1st line recurrent or metastatic HNSCC from the United States Food and Drug Administration
Fast Track has been granted for the development program of efti for 1st line treatment of
recurrent or metastatic HNSCC due to its potential to address an unmet medical need, as evidenced by encouraging data indicating a positive risk benefit ratio.
The data package evaluated by the FDA included the promising results from Part C of Immutep s Phase II TACTI-002
trial evaluating efti in combination with KEYTRUDA (pembrolizumab) 2nd line PD-X naive HNSCC, and its plans for a trial in 1st line HNSCC (TACTI-003). Interim clinical data from TACTI-002 was presented at the Society for Immunotherapy of Cancer
(SITC) in November 2020. The Overall Response Rate (ORR) reported at SITC was approximately 36% (approximately 44% in evaluable patients) for 28 patients receiving efti in combination with KEYTRUDA.
On 16 March 2021, Immutep announced that it had entered into a second collaboration with MSD (Merck & Co. Inc., Kenilworth, NJ, USA) to evaluate
efti in combination with KEYTRUDA in a new Phase IIb trial in 1st line HNSCC, TACTI-003. Planning for this trial is advancing well and the study is expected
to start in mid-2021.
About Fast Track designation
FDA Fast Track designation is awarded to help important new therapies reach patients earlier. It is designed to facilitate the development and expedite the
review of drug candidates to treat serious conditions and fill an unmet medical need. Importantly, Immutep will now have access to more frequent meetings and communications with the FDA, potentially receive Rolling Review of its Biologic License
Application (once submitted) and may be eligible for Accelerated Approval and Priority Review, if relevant criteria are met, for efti in HNSCC.
information on Fast Track designation is available on the US FDA s website.
Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related
immunotherapeutic products for the treatment of cancer, infectious disease, and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to
shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.
Immutep s current 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 and infectious disease. Immutep is also developing an agonist of LAG-3 (IMP761) for
autoimmune disease. Additional LAG-3 products, including antibodies for immune response modulation, are 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:
+61 (0)406 759 268; cstrong@citadelmagnus.com
Tim McCarthy, LifeSci Advisors
+1 (212) 915.2564; tim@lifesciadvisors.com
announcement was authorised for release by the Board of Immutep Limited.