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Immutep Announces Data from Ongoing TACTI-mel Phase I Clinical Trial in Unresectable or Metastatic Melanoma

May 17, 2019

Presented at the World Advanced Therapies & Regenerative Medicine Congress & Expo 2019

SYDNEY, Australia, May 17, 2019 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep“ or “the Company“), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, today announces more mature data relating to Part B of its ongoing phase I TACTI-mel clinical study of the Company’s lead product candidate, eftilagimod alpha (“efti” or “IMP321”) in patients with melanoma. The data was presented at the World Advanced Therapies & Regenerative Medicine Congress & Expo 2019 in London on May 17, 2019 by Dr Frédéric Triebel, Chief Scientific Officer and Chief Medical Officer of Immutep.

The ongoing TACTI-mel trial evaluates the combination of efti with anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in 24 patients with unresectable or metastatic melanoma. It is a multi-center, open label clinical trial that involves four cohorts of six patients, each cohort testing different dosages of efti, including 1 milligram (mg), 6 mg and 30 mg, in combination with pembrolizumab. Part B of the study includes a 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.

Consistent with previous data reported at 6 months of combination treatment (March 2019), patients in Part B continue to report positive results in terms of tumour reductions after 9 months of treatment. Four patients are continuing to receive treatment. No new safety data or data from Part A of the study have been reported. The key findings from Part B are:

Part B(starting cycle 1, day 1 of pembro therapy) N=6 --------------------------- ------------------------------------------------- Overall Response Rate (ORR) 50% --------------------------- ------------------------------------------------- Disease Control Rate (DCR) 66% --------------------------- -------------------------------------------------

The full presentation slides from the World Advanced Therapies & Regenerative Medicine Congress & Expo 2019 can be accessed via Immutep’s website at www.immutep.com.

About the TACTI-mel clinical trial

The ongoing TACTI-mel (Two ACTive Immunotherapies in melanoma) Phase I clinical trial is a multicenter, 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).

About Immutep

Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States. Further information can be found on the Company’s website www.immutep.com or by contacting:

U.S. Investors: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+61 2 8234 0105; mgregorowski@citadelmagnus.com