Immutep Submits Investigational New Drug (IND) Application With FDA
July 02 2018 - 8:00AM
Immutep Limited (ASX:IMM) (NASDAQ:IMMP) (“Immutep” or “the
Company”) is pleased to announce that it has submitted its
Investigational New Drug (“IND”) application to the United States
Food and Drug Administration (“FDA”) for eftilagimod alpha (“efti”
or “IMP321”) in June 2018.
If granted by the FDA, the IND application will
allow Immutep to ship efti across U.S. State borders to U.S.
clinical investigators participating in the Company’s planned
TACTI-002 Phase II clinical study, making it an important step in
the clinical trial preparations. This is the first IND application
for efti in the U.S. following the encouraging pre-IND meeting in
November last year.
The IND application incorporates information
pertaining to completed pharmacology and toxicology studies for
efti, along with manufacturing information and proposed clinical
protocol for the TACTI-002 trial.
The Company continues to progress its
preparations for the TACTI-002 clinical trial in the United States,
Europe and Australia. Immutep expects to commence the TACTI-002
trial in the second half of 2018 and to report the first data from
the trial in 2019.
About the TACTI-002 clinical trial
Up to 120 patients will be recruited for the
TACTI-002 (Two ACTive Immunotherapies) Phase II study which will
take place across approximately 15 study centres in the U.S.,
Europe and Australia. The trial is being conducted in collaboration
with Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD”
outside the United States and Canada). It will evaluate the safety
and efficacy of the combination of efti with MSD’s KEYTRUDA®
(pembrolizumab) in patients with two different types of cancers,
non-small cell lung cancer and head and neck cancer. It will be a
Simon’s two-stage, non-comparative, open-label, single-arm,
multicentre clinical study. Patients participating in the trial
will be given the combination treatment for 12 months using a 30 mg
s.c. efti dosing every 2 or 3 weeks.
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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