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ASX/Media Release (Code: ASX: IMM; NASDAQ: IMMP) Immutep Reports Positive Final Efficacy Data from TACTI-mel Trial in Melanoma Key Trial Findings Favourable safety profile of eftilagimod alpha in combination with pembrol

Key Takeaway: ASX/Media Release (Code: ASX: IMM; NASDAQ: IMMP) Immutep Reports Positive Final Efficacy Data from TACTI-mel Trial SYDNEY, AUSTRALIA October 15, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ( Immutep or the Company ), a biotechnology company developing novel immunotherapy tre

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ASX/Media Release (Code: ASX: IMM; NASDAQ: IMMP)
Immutep Reports Positive Final Efficacy Data from TACTI-mel Trial
SYDNEY, AUSTRALIA October 15, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ( Immutep or
the Company ), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, today announces mature positive efficacy data from its TACTI-mel Phase I clinical
study combining its lead product candidate, eftilagimod alpha ( efti or IMP321 ) with KEYTRUDA (pembrolizumab) in metastatic melanoma.
The data will be presented by Dr. Fr d ric Triebel, Chief Scientific Officer and Chief Medical Officer of Immutep at the World
Immunotherapy Congress as part of the Festival of Biologics 2019 being held in Basel, Switzerland on 15th October 2019.
Commenting on the positive results, Dr. Triebel said, The combination therapy with efti shows very encouraging efficacy signals of synergy with
KEYTRUDA along with a favourable safety profile so far in this high-risk patient population. Patients are responding well to the combination treatment, their tumours are shrinking and not growing back over a long follow up period. In addition, we
have seen the complete disappearance of all target tumour lesions for six patients plus one patient with a metabolic complete response on the PET-scan. The efficacy data is now final with a long follow up, the
safety assessment is ongoing.
TACTI-mel evaluated the combination of efti with
anti-PD-1 therapy KEYTRUDA (pembrolizumab) in 24 patients with unresectable or metastatic melanoma. Patients
participating in the trial had a very late stage of disease: 75% classified as M1c (associated with lowest probability of survival), 67% had lung metastasis, 50% had liver metastasis, 50% had elevated LDH (poor prognosis marker) and many had either
a suboptimal response or disease progression with pembrolizumab treatment as a monotherapy. All patients received subcutaneous injections of efti every two weeks, with a treatment duration of up to either six or 12 months.
TACTI-mel is a multi-centre, open label clinical trial involving four cohorts of six patients per cohort:
The primary endpoint of the trial is safety and tolerability,
with the outcome to determine the recommended dose for a Phase II trial. The trial also evaluated efficacy through Overall Response Rate (ORR), tumour shrinkage and Disease Control Rate (DCR).
The key efficacy findings from the trial are:
Measured according to irRC Part A* N=18 Part B** N=6 Part A + B C1D1 analysis*** N=24
Overall Response Rate (ORR) 6 (33%) 3 (50%) 14 (58%)
Patients with tumour shrinkage 10 (56%) 4 (66%) 17 (71%)
Disease Control Rate (DCR) 12 (66%) 4 (66%) Not reported
Progression free at 6 months Not reported 4 (66%) 14 (58%)
The full presentation is available on
TACTI-mel clinical trial
The TACTI-mel (Two ACTive Immunotherapies in
melanoma) Phase I clinical trial is a multicentre, open-label study evaluating the combination of eftilagimod alpha ( efti ) with pembrolizumab, in unresectable or metastatic melanoma patients that have had either a suboptimal response or
had disease progression with pembrolizumab monotherapy (clinicaltrials.gov identifier NCT 02676869).
Immutep is a globally active biotechnology company that is a leader in the development of 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-3Ig fusion protein based on the LAG-3 immune control mechanism, is a best-and-first-in-class MHC II agonist. This mechanism plays a vital role in the regulation of the T cell immune response. Efti is currently in a Phase IIb
clinical trial as a chemoimmunotherapy for metastatic breast cancer termed AIPAC; a Phase II clinical trial being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and
Canada) referred to as TACTI-002 (Two ACTive Immunotherapies) to evaluate a combination of efti with KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in several different solid tumours (clinicaltrials.gov identifier NCT03625323); a Phase I clinical trial being conducted in collaboration with Merck KGaA,
Darmstadt, Germany and Pfizer Inc. referred to as INSIGHT-004 to evaluate a combination of efti with avelumab (clinical trials.gov identifier NCT03252938); and a Phase I combination therapy trial in metastatic
melanoma termed TACTI-mel (clinicaltrials.gov identifier NCT02676869). Immutep is also developing a LAG-3 agonist monoclonal antibody for autoimmune diseases (IMP761)
that is currently in preclinical development.
Further information can be found on the Company s website www.immutep.com or by contacting:
Jay Campbell, Chief Business
Officer, Immutep Limited
+1 (917) 860-9404; jay.campbell@immutep.com
Garth Russell, LifeSci Advisors
+1 (646) 876-3613; garth@lifesciadvisors.com
Australian Investors/Media:
Matthew Gregorowski, Citadel-MAGNUS
Last updated: Oct 15, 2019