Full Press Release Details
ASX/Media Release (Code: ASX: IMM; NASDAQ: IMMP)
SYDNEY, AUSTRALIA Immutep Limited (ASX: IMM; NASDAQ: IMMP) ( Immutep or the Company ), provides an operational update on the
Company s ongoing development activities for its lead product candidates, eftilagimod alpha ( efti or IMP321 ), and IMP761, along with partner updates.
Efti Clinical Update
The first two out of six patients
of the additional cohort of the Company s TACTI-mel (Two ACTive Immunotherapeutics in melanoma) Phase I clinical trial in Australia have commenced their treatment. This follows
the recruitment of all 18 patients in the initial three cohorts of TACTI-mel and the subsequent expansion of the trial to include an additional cohort of six patients in February 2018. The TACTI-mel trial evaluates the combination of efti and anti-PD-1 therapy
KEYTRUDA (pembrolizumab) in unresectable or metastatic melanoma patients, with the additional cohort receiving 30mg of efti in combination with pembrolizumab starting at cycle one of
pembrolizumab. The Company plans to present data from the TACTI-mel trial in the middle of this calendar year.
the AIPAC (Active Immunotherapy PAClitaxel) clinical trial, 33 out of a planned 34 clinical sites across Belgium, the Netherlands, Poland, Hungary, United Kingdom, France and Germany are now actively recruiting and treating
patients. The trial evaluates efti in combination with paclitaxel in metastatic breast cancer. The study remains on track to be to be fully recruited with 226 patients in Q3 of calendar year 2018; first Progression Free Survival data are expected in
Six patients have now been recruited for the investigator-initiated Phase I clinical trial INSIGHT, which is being conducted in
Frankfurt, Germany. These patients are receiving escalating doses of efti either via local (intratumoral) or loco-regional (intraperitoneal) injection. The objective of the study is to determine the recommended dose for each administration route for
an intended Phase II clinical trial.
Following the Company s announcement on 12 March 2018 of its collaboration and supply agreement with
Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada), through a subsidiary, to evaluate the combination of Immutep s lead immunotherapy product candidate, efti with MSD s anti-PD-1 therapy KEYTRUDA (pembrolizumab), Immutep is preparing to start its new clinical trial program TACTI-002 (Two ACTive Immunotherapies) in the second half of calendar 2018. This new trial will evaluate the combination of efti with KEYTRUDA in patients
with advanced non-small cell lung cancer, head and neck cancer, or ovarian cancer. The Company plans to file the respective Investigational New Drug application (IND) with the U.S. Food and Drug Administration
(FDA) in the first half of calendar 2018.
Immutep s IMP761 (a LAG-3-specific antibody with unique agonistic
properties) is currently being tested in vivo in animal models. IMP761 is the first known therapeutic agonist LAG-3 antibody. To our knowledge, no other company has developed a therapeutic agonist antibody to
one of the three main immune checkpoint molecules, namely CTLA-4, PD-1 and LAG-3, as an immuno-suppressive drug for auto-immune
Efti Partnering Update
Chinese partner for efti, EOC Pharma, an oncology focused affiliate of Eddingpharm, received approval for the IND status in China and is expected to start clinical development in China with efti in H1 2018.
pleased to report that its partner CYTLIMIC has started a Phase I clinical trial for adjuvant immunotherapy at the Yamaguchi University Graduate School of Medicine in Japan. The study is the second that will test CYTLIMIC s cancer peptide
vaccine in combination with efti.
Immutep is a globally active biotechnology company that is a leader in the development of immunotherapeutic products for the treatment of cancer. Immutep is
dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximise value to shareholders.
Immutep s current lead product 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 has completed early Phase II trials as an APC activator
boosting T cell responses for cancer chemo-immunotherapy. Additional LAG-3 products, including antibodies, for immune response modulation in autoimmunity and cancer are being developed by Immutep s large
pharmaceutical partners. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease.
is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the U.S.
For further information please visit www.immutep.com
President of Business Development and Investor Relations, Immutep Limited
Australian Investors/Media:
Matthew Gregorowski, Citadel-MAGNUS