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ASX/Media Release (Code: ASX: IMM; NASDAQ: IMMP)
New Data from Ongoing TACTI-mel Study in Unresectable or Metastatic Melanoma
Presented at the 4th Annual ICI Europe Summit
SYDNEY, AUSTRALIA November 27, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP)
( Immutep or the Company ), announces new data from its ongoing TACTI-mel Phase I clinical trial is being presented at the 4th Annual ICI Europe Summit in Berlin, Germany by
Dr. Fr d ric Triebel, Immutep s Chief Scientific Officer and Chief Medical Officer. The study is evaluating the combination of eftilagimod alpha ( efti or IMP321 ), Immutep s lead product candidate,
in combination with anti-PD-1 therapy KEYTRUDA (pembrolizumab) in 24 patients with unresectable or metastatic melanoma.
The multi-center, open-label clinical trial includes four cohorts of six patients each testing different dosages of efti,
including 1 milligram (mg), 6 mg and 30 mg, in combination with pembrolizumab. This latest data includes more mature data from the first three cohorts (part A, the dose escalation part of the study) where the combination treatment begins at cycle 5
of pembrolizumab treatment and the first efficacy data from the fourth cohort (part B) where the combination treatment is administered to patients from the beginning of cycle 1, day 1 of pembrolizumab treatment.
Key findings from part B (n=6) were as follows:
Key findings from part A (n=18) were as follows:
We are very pleased by this initial data which further supports our hypothesis
that the combination of efti and pembrolizumab may be a hopeful solution for cancer patients, said Frederic Triebel, CSO and CMO of Immutep. Based on these encouraging results we are looking forward to the start of our TACTI-002 trial
where exactly this combination will be tested in three different cancer indications.
The presentation slides are
available on the Company s website at https://www.immutep.com/investors-media/presentations.html
The ongoing TACTI-mel (Two ACTive Immunotherapies in melanoma) Phase I
clinical trial is a multi-center, 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).
Part A of the study is dosing
escalating (1, 6 or 30 mg of efti), starting the combination treatment at cycle 5 in three cohorts of six patients with a treatment duration of 6 months. Part B of the study includes an additional cohort of 6 patients at 30 mg of efti in combination
with pembrolizumab, starting at cycle 1, day 1 and with a treatment duration of 12 months.
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. 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 (clinicaltrials.gov identifier NCT02614833); a Phase II clinical trial referred to as TACTI-002 (Two ACTive Immunotherapies) to evaluate a combination of Efti
with KEYTRUDA (pembrolizumab) in several different solid tumours (clinicaltrials.gov identifier NCT03625323); a planned Phase I clinical trial 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).
Further information can be found on the Company s website
www.immutep.com or by contacting:
Jay Campbell, Vice President of Business Development and Investor Relations, Immutep Limited
+1 (917) 860-9404; jay.campbell@immutep.com
Australian Investors/Media:
Matthew Gregorowski, Citadel-MAGNUS
+61 2 8234 0105; mgregorowski@citadelmagnus.com
Russell, LifeSci Advisors
+1 (646) 876-3613; garth@lifesciadvisors.com