ASX/Media Release Immutep receives FDA and IRB approval in the US for Phase IIb TACTI-003 trial in HNSCC Regulatory steps completed with the competent authority (FDA) and institutional review board (IRB) approval receive

Immutep receives FDA and IRB approval in the US for Phase IIb TACTI-003 trial in HNSCC

SYDNEY, AUSTRALIA 6 July 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP)

( Immutep or the Company ), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, announces it has completed all the necessary

competent authority steps with the US Food and Drug Administration (FDA) and has received IRB approval to commence its phase IIb TACTI-003 trial in the United States. Patient recruitment for the TACTI-003 trial is expected to begin within this quarter.

evaluate the Company s lead product candidate, eftilagimod alpha ( efti or IMP321 ), in combination with MSD s KEYTRUDA (pembrolizumab) as a first line therapy

in approximately 154 patients with Head and Neck Squamous Cell Carcinoma (HNSCC). It is a randomised, controlled clinical study that will take place across Australia, Europe and the United States of America in up to 35 clinical sites.

Immutep was granted Fast Track designation for efti to treat 1st line HNSCC patients by the US FDA in early April 2021.

Pending approval by the European and Australian competent authorities and ethics committees, Immutep expects to broaden its recruitment sites into these

Commenting on the start of the TACTI-003 trial, Immutep CSO and CMO

Fr d ric Triebel said: We are delighted to start our new TACTI-003 trial in

1st line HNSCC patients to evaluate efti in combination with pembrolizumab vs pembrolizumab monotherapy. Results we reported from this therapeutic combination earlier in June at ASCO in the 2nd line setting were robust, with sustained and durable responses. We look forward to deepening these results with a larger group of 1st line HNSCC

patients in TACTI-003.

TACTI-003 is a Phase IIb clinical trial in 1st line Head and Neck Squamous Cell Carcinoma (HNSCC). It will evaluate

efti in combination with MSD s KEYTRUDA (pembrolizumab) as a first line therapy in unresectable recurrent or metastatic HNSCC patients with PD-L1

negative and PD-L1 positive (CPS 1) tumors. It will be a randomised, controlled clinical study in approximately 154 first line HNSCC patients and will take place

across Australia, Europe and the United States of America in up to 35 clinical sites.

Level 12, 95 Pitt Street, Sydney NSW 2000

The study will evaluate the safety and efficacy of efti in combination with pembrolizumab, compared to

pembrolizumab alone in 1st line metastatic or recurrent HNSCC patients with PD-L1 positive (CPS 1) tumors (cohort A), and determine the efficacy and safety of efti

plus pembrolizumab in patients with PD-L1 negative tumors (CPS <1) (cohort B). According to the current plans, about 130 patients in cohort A will be randomised 1:1 to receive either efti plus pembrolizumab

or pembrolizumab alone. Subjects in cohort B (up to 24 patients) will receive a combination of efti and pembrolizumab.

The primary endpoint of the study

is the Overall Response Rate (ORR) according to RECIST 1.1. and iRECIST will be used for treatment decisions. Secondary endpoints include OS and Progression Free Survival (PFS).

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 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:

Catherine Strong, Citadel-MAGNUS

McCarthy, LifeSci Advisors

+1 (212) 915.2564; tim@lifesciadvisors.com

This announcement was authorised for release by the Board of Immutep Limited.

Level 12, 95 Pitt Street, Sydney NSW 2000