Full Press Release Details
ASX/Media Release (Code: ASX: IMM; NASDAQ: IMMP)
Immutep Announces Data from Ongoing TACTI-mel Phase I Clinical Trial in Unresectable or Metastatic Melanoma
Presented at the World Immunotherapy Congress USA 2019
SYDNEY, AUSTRALIA 6 March 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) (Immutep or the Company), a biotechnology company developing novel
immunotherapy treatments for cancer and autoimmune diseases, today announced positive, more mature data from its ongoing TACTI-mel phase I clinical study of the Company s lead product candidate, eftilagimod alpha ( efti or
IMP321 ). The data will be presented at the World Immunotherapy Congress 2019 in San Diego USA, by Dr. Fr d ric Triebel, Immutep s Chief Scientific Officer and Chief Medical Officer at 3:00 PM Pacific Standard Time
The TACTI-mel study is evaluating 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 A of the study is starting the combination therapy at cycle 5 of the pembrolizumab treatment in three cohorts with a treatment duration of 6 months. 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.
Key findings from the ongoing trial were as follows:
| Part A (starting cycle 5 of pembro therapy) N=18 | Part B (starting day 1 cycle 1 of pembro therapy) N=6 | |||
| Overall Response Rate (ORR) | 33% (61%*) | 50% | ||
| Disease Control Rate (DCR) | 66% | 66% |
*Exploratory ORR when tumour size is measured according to irRC from day 1 of cycle 1 of pembrolizumab and following
combination therapy (which starts at cycle 5 of prembrolizumab treatment).
Safety results (total n=24):
Notes to the results
The full presentation slides from this event can be accessed via Immutep s website.
Immutep CSO and CMO, Fr d ric Triebel, CEO, Marc Voigt and Director of Clinical Development, Christian Mueller will discuss the data, along with
the clinical development program for IMP321, including other trials, on a global webcast in the coming weeks. Details of the webcast will be announced separately.
About the TACTI-mel clinical trial
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).
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:
Campbell, Chief Business Officer, Immutep Limited
+1 (917) 860-9404; jay.campbell@immutep.com
Australian Investors/Media:
Matthew Gregorowski,
+61 2 8234 0105; mgregorowski@citadelmagnus.com
Garth Russell, LifeSci Advisors
+1 (646) 876-3613; garth@lifesciadvisors.com