Immutep (ASX:IMM) has launched a fully underwritten equity raising of approximately $100 million and a Phase 3 clinical trial collaboration with MSD.
The Phase 3 trial (TACTI-004) will study Immutep's novel LAG-3 immunotherapy eftilagimod alfa (efti) in combination with MSD's KEYTRUDA (pembrolizumab) and chemotherapy for the first-line treatment of metastatic non-small cell lung cancer (NSCLC).
"We are eager to build upon the meaningful impact that immunotherapy has brought to patients with NSCLC, one of the largest cancer indications globally, and look for TACTI-004 to confirm the clinical benefits that have been achieved with efti in combination with KEYTRUDA. This collaboration agreement speaks to the strength of the clinical data generated to date from this novel immuno-oncology combination and its future potential. We are thankful for this significant commitment from MSD," said Immutep CEO Marc Voigt.
The TACTI-004 study follows two previous trials (TACTI-002 Phase II and TACTI-003 Phase IIb) that involved over 350 patients. The Phase 3 TACTI-004 study would enrol approximately 750 patients. It is a randomised, double-blinded, multinational study with the first patient expected to be enrolled in late 2024.
Under the terms of the agreement, Immutep will conduct the TACTI-004 study and MSD will supply KEYTRUDA. The agreement enables Immutep and MSD to seek marketing authorisation of the combination and to market their respective compounds with a relevant label indication.
Immutep will advance the study using the $100 million raised via a $72 million institutional placement and a $28.2 million offer to eligible Immutep shareholders.
The company said the raise means it expects to be fully funded for its current clinical program and until the end of the calendar year 2026 with a pro-forma cash balance of approximately $195 million.
