Immutep: LAG-3 Immunostimulant Product Candidate Efti Gets FDA's IND Approval

(RTTNews) - Australia-based Immutep Limited (IMM.AX, IMMP) announced late Monday the approval of its Investigational New Drug or IND application by the U.S. Food and Drug Administration for eftilagimod alpha or efti or IMP321, a LAG-3Ig fusion protein.

In the after hours trading on Nasdaq, Immutep shares gained 5.8 percent and traded at $2.75.

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.. The study will evaluate the combination of efti and anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with non-small cell lung carcinoma or NSCLC or head and neck carcinoma.

Merck & Co Inc. (MRK) developed anti-PD-1 therapy KEYTRUDA.

The IND application allows 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.

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.

Marc Voigt, CEO of Immutep said, "This is one more important milestone for the Company's pipeline of LAG-3 immunotherapeutic products that aim to transform the treatment of cancer and autoimmune diseases."