New approval for trial of Immutep's 'efti' with Merck's PD-L1 inhibitor

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Immutep (ASX IMM) has received regulatory approval from the Paul-Ehrlich-Institut, German Federal Institute for Vaccines and Biomedicines, to initiate a new investigator-initiated trial of eftilagimod alpha.

The trial, INSIGHT-005, is an open-label Phase I trial evaluating the safety and efficacy of eftilagimod alpha (efti) in combination with BAVENCIO (avelumab) in up to 30 patients with metastatic urothelial carcinoma.

Merck's BAVENCIO is a PD-L1 inhibitor. It targets and blocks the PD-L1 protein on the surface of cancer cells and certain immune cells, activating the cells to find and kill cancer cells.

Efti is a soluble LAG-3 protein and novel MHC Class II agonist. It was previously evaluated in combination with BAVENCIO in patients with advanced solid tumours in the INSIGHT-004 Phase I trial.

“We are excited to get this important trial underway. In addition to possibly bringing a new chemo-free treatment option to patients with advanced urothelial cancer, we hope to further build upon the encouraging clinical data we have seen to date combining efti and avelumab in other challenging cancers," said Immutep CEO, Marc Voigt.

"Efti’s unique activation of antigen-presenting cells to fight cancer has shown a benefit with avelumab, and we believe this dual IO-IO approach has broad potential to drive superior clinical outcomes across a variety of indications, including bladder cancer where avelumab monotherapy has regulatory approval,”

INSIGHT-005 will be conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt as part of the investigator-initiated INSIGHT platform for studies investigating efti in different combination treatments and routes of administration.