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The agreement will see Immutep and Merck KGaA, Darmstadt, Germany jointly fund the INSIGHT-005 study.
Immutep, a clinical-stage biotechnology company, announced that it had signed a second clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany, and Pfizer, on Nov. 29, 2022. The new agreement concerns INSIGHT-005, a Phase I clinical study of Immutep’s lead candidate eftilagimod alpha, a soluble lymphocyte activation gene 3 fusion protein, in combination with avelumab in patients with urothelial cancer. It follows the INSIGHT-004 trial, which evaluated the treatment in patients with advanced solid cancers and posted results in June 2021.
According to a company press release, INSIGHT-005 will be an investigator-initiated explorative, open-label study evaluating the safety and efficacy of the drug in up to 30 patients with metastatic urothelial cancer. Jointly funded by Immutep and Merck KGaA, the study will be conducted in Germany by the Institute of Clinical Cancer Research, Krankenhaus Nordwest. It is expected to begin enrollment in the first half of 2023.
“We are very pleased to be deepening our collaboration with Merck KGaA, Darmstadt, Germany and Pfizer through this new study in patients with urothelial cancer, the sixth most common cancer in the US, who are in need of treatment options,” said Marc Voigt, CEO, Immutep, in the release.“INSIGHT-005 builds on the encouraging clinical efficacy and safety previously reported from the combination of [eftilagimod alpha] and avelumab in various solid cancers, including deep and durable responses in patients with low or no [programmed death-ligand 1] expression and in indications that typically do not respond to immune checkpoint therapy.”