Immutep Receives Regulatory Feedback On TACTI-004 Trial In Metastatic NSC Lung Cancer

(RTTNews) - Clinical-stage biotechnology company Immutep Ltd. (IMMP) announced Thursday that it has received constructive regulatory feedback on the TACTI-004 registrational trial of Phase III trial of eftilagimod alpha in metastatic non-small cell lung cancer from the Paul-Ehrlich-Institut or PEI, and part of the Committee for Medicinal Products for Human Use or CHMP.

Immutep plans to announce its final trial design for TACTI-004 in the first quarter. Efti is a proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer.

The Paul-Ehrlich-Institut is supportive of moving into a registrational trial and evaluating efti in combination with anti-PD-1 therapy in a chemotherapy-free regimen or as a triple combination approach that includes chemotherapy. Also, the PEI acknowledged the safety profile of efti in combination with anti-PD-1 therapy.

The company said additional interactions with the FDA, other local European regulators, as well as with other stakeholders and potential partners are ongoing.