Sydney, Sept. 01, 2021 (GLOBE NEWSWIRE) —

• Last 2
  
  ^nd
  
  line PD-1/PD-L1 refractory non-small cell lung cancer (NSCLC) patient has been enrolled and safely dosed, completing recruitment of Stage 2 of Part B
• Total of 154 patients out of up to 183 patients (84%) now participating in the expanded trial, with recruitment continuing for the expansion stage of Part A
• Further data expected to be reported in calendar year 2021 or early calendar year 2022

SYDNEY, AUSTRALIA – 1 September


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 that the last patient has been enrolled and safely dosed in Stage 2 of Part B of its Phase II TACTI-002 study (also designated KEYNOTE-798). This completes the recruitment of 2

^nd

line PD-1/PD-L1 refractory non-small cell lung cancer (NSCLC) patients into the trial.

Immutep expects to report further data from TACTI-002 at a scientific conference in calendar year 2021 or early calendar year 2022.

Patient recruitment is now complete for Parts B and C of TACTI-002 and continues to progress well for the expansion stage of Part A (see

Table 1

). A total of 154 patients out of up to 183 are now participating in TACTI-002 at currently 19 clinical sites across Australia, Europe, the UK and US.

Table 1

– TACTI-002 Recruitment (as at 24

^th

August 2021)

The data presented for 2nd line PD-1/PD-L1 resistant NSCLC at the Society for Immunotherapy of Cancer (SITC) 35th Anniversary 2020 Annual Meeting as part of a late breaker poster looked encouraging, especially when compared to alternative treatment options. Based on the data, the DMC confirmed a positive risk-benefit-ratio in this very difficult to treat patient population with confirmed progression (i.e. two consecutive scans) and often low PD-L1 expression levels and recommended the opening of Stage 2 of this part in March 2021.


About the TACT-002 Trial


TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada). The study is evaluating the combination of efti with MSD’s KEYTRUDA® (pembrolizumab) in up to 183 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in study centres across Australia, Europe, the UK and US.

Patients participate in one of the following:

•             Part A – First line Non-Small Cell Lung Cancer (NSCLC), PD-X naive

•             Part B – Second line NSCLC, PD-X refractory

•             Part C – Second line Head and Neck Squamous Cell Carcinoma (HNSCC), PD-X naive

TACTI-002 is an all-comer study in terms of PD-L1 status, a well-known predictive marker for response to pembrolizumab monotherapy especially in NSCLC and HNSCC. PD-L1 expression is typically reported in three groups for NSCLC: < 1%, 1-49% and ≥ 50% (Tumour Proportion Score or TPS) and in HNSCC: < 1, 1-19 and ≥ 20 (Combined Positive Score or CPS). Patients with a high PD-L1 status are typically more responsive to anti-PD-1 therapy such as pembrolizumab, whereas those with low PD-L1 status are overall significantly less responsive.

More information about the trial can be found on Immutep’s website or on ClinicalTrials.gov (Identifier:

NCT03625323)

About Immutep

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;

[email protected]

U.S. Media:


Tim McCarthy, LifeSci Advisors

+1 (212) 915.2564;

[email protected]

¹

Two extra patients were treated as allowed under the trial protocol since 2 patients had dropped out due to Covid-19 prior to first post-baseline staging.