Full Press Release Details
IMMUTEP EXPANDS PART C OF TACTI-002 DUE TO POSITIVE DATA
SYDNEY, AUSTRALIA January 9, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP)
( Immutep or the Company ), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, provides an update on its TACTI-002 and AIPAC studies for
its lead product candidate, eftilagimod alpha ( efti or IMP321 ).
The requisite number of predefined patient responses was observed in stage 1 of Part C. The decision by the DMC to recommend
opening stage 2 recruitment follows its review of preliminary safety and efficacy data and is based on a predefined efficacy threshold.
the Company to now proceed with the recruitment of an additional 19 patients, forming stage 2 of Part C of the study, having now also completed recruitment of the 18 HNSCC patients for stage 1. The staged approach to patient
enrolment is based on the study s Simon s two-stage clinical trial design.
(first line Non-Small Cell Lung Cancer, NSCLC) was expanded in September 2019. Recruitment is ongoing for Part B (second line NSCLC) with 10 out of 23 patients now participating, and for stage 2 of
Part A (first line NSCLC), where 4 out of 19 patients are now participating. The Company expects to report more mature data from TACTI-002 in Q1 CY20.
TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as
MSD outside the United States and Canada).
Immutep CSO and CMO, Dr Frederic Triebel said: The study is progressing well as the
expansion of Part C to include 19 additional patients with second line HNSCC marks the second out of three parts of our TACTI-002 study to be expanded, having already observed the pre-determined number of partial responses in Parts A and C patients.
AIPAC Phase IIb study in
metastatic breast cancer
The Company continues to progress its AIPAC trial which evaluates efti in combination with chemotherapy in 227 metastatic
breast cancer patients in a randomized, double blinded, placebo-controlled phase IIb clinical trial. The first progression-free survival read-out remains on track for Q1 CY20 and is expected to be
reported in March 2020.
Level 12, 95 Pitt Street, Sydney NSW 2000
TACTI-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 MSD s KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) 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, Simon s two-stage, non-comparative, open-label, single-arm, multicentre
clinical study that is taking place in up to 13 study centres across the U.S., Europe and Australia.
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; 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).
This announcement was authorised for release by the board of Immutep Limited.
Further information can be found on the Company s website www.immutep.com or by contacting:
Australian Investors/Media:
+61 (0)406 759 268; cstrong@citadelmagnus.com
Garth Russell, LifeSci Advisors
+1 (646) 876-3613; garth@lifesciadvisors.com
Level 12, 95 Pitt Street, Sydney NSW 2000