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.
In 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 calendar year
2019.
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.
IMP761 Update
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 diseases.
Efti Partnering Update
EOC PharmaImmutep’s 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.
CYTLIMIC Immutep is also
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.
About Immutep
Immutep 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 or contact:
U.S. Investors: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
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