GlobeNewswire Inc | Aug 18, 2020 08:00AM EDT

August 18, 2020

-- 23 patients with second line Non-Small Cell Lung Cancer (NSCLC) participating in Stage 1, Part B -- Total of 87 patients out of up to 109 patients (80%) are enrolled and participating in the trial, with recruitment continuing for stage 2 of Part C at present -- Further data from TACTI-002 expected throughout calendar year 2020

SYDNEY, Australia, Aug. 18, 2020 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep or the Company), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, is pleased to report it has enrolled and safely dosed the last patient for stage 1 of Part B of its TACTI-002 Phase II study, completing recruitment of stage 1 of Part B.

Based on the studys Simons two-stage clinical trial design, safety and efficacy data will be provided to the Data Monitoring Committee (DMC) for its review and recommendation regarding opening recruitment into stage 2 of Part B once all patients have undergone at least one tumour imaging after treatment.

TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada) and is evaluating the combination of Immuteps lead product candidate, eftilagimod alpha (efti or IMP321) with MSDs KEYTRUDA (pembrolizumab) in up to 109 patients with second line Head and Neck Squamous Cell Carcinoma (HNSCC) or NSCLC in first and second line.

TACTI-002 Recruitment Recruitment details for each Part of TACTI-002 are below. At present, recruitment is ongoing for Stage 2 of Part C. Pending the DMCs recommendation, Immutep will consider opening stage 2 of Part B for recruitment.

Stage 1 (N) Stage 2 (N) Recruitment Actual/target Actual / target statusPart A (1st line NSCLC) 17/17 19/19 COMPLETEPart B (2nd line NSCLC) 23/23 -/13 TBAPart C (2nd line HNSCC) 18/18 10/19 ONGOING

About the TACT-002 TrialTACTI-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 MSDs KEYTRUDA (pembrolizumab) in up to 109 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, Simons two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in up to 12 study centres across the U.S., Europe and Australia.

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. PD-L1 expression is typically reported in three groups for NSCLC: < 1%, 1-49% and 50% (Tumour Proportion Score or TPS). Patients with a high PD-L1 status are typically more responsive to anti-PD-1 monotherapy such as pembrolizumab, whereas those with low PD-L1 status are overall significantly less responsive. Pembrolizumab monotherapy is registered in the US and the EU for first-line NSCLC patients with a TPS score 1% (US) and 50% (EU), reflecting 65% and 30% of all first line NSCLC patients, respectively.

More information about the trial can be found on Immuteps website or on ClinicalTrials.gov (Identifier: NCT03625323).

About Immutep

Further information can be found on the Companys website www.immutep.com or by contacting:

Australian Investors/Media:Catherine Strong, Citadel-MAGNUS+61 (0)406 759 268; cstrong@citadelmagnus.com

U.S. Media:Tim McCarthy, LifeSci Advisors+1 (212) 915.2564;tim@lifesciadvisors.com