Immutep Announces Immunostimulant Product Candidate EFTI Receives IND Approval from US FDA | Finance News Network

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Immutep Announces Immunostimulant Product Candidate EFTI Receives IND Approval from US FDA

On schedule to initiate the TACTI-002 Phase II clinical study in 2H 2018

SYDNEY, AUSTRALIA - Immutep Limited (ASX:IMM; NASDAQ:IMMP) (“Immutep” or “the Company”) is pleased to announce the approval of its Investigational New Drug (“IND”) application by the U.S. Food and Drug Administration (“FDA”) for eftilagimod alpha (“efti” or “IMP321”), a LAG-3Ig fusion protein.

The FDA approval of the IND allows the Company, subject to the completion of other preparatory steps, to initiate the TACTI-002 Phase II clinical study in the U.S. that will evaluate the combination of efti and anti- PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with non-small cell lung carcinoma (“NSCLC”) or head and neck carcinoma. 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.


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