Immutep (IMMP) announces it has signed a Clinical Trial Collaboration and Supply Agreement with Merck KGaA (MKKGY), Darmstadt, Germany and Pfizer for a new Phase I clinical study in patients with urothelial cancer, called INSIGHT-005. "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 Immutep CEO, Marc Voigt. "INSIGHT-005 builds on the encouraging clinical efficacy and safety previously reported from the combination of efti and avelumab in various solid cancers, including deep and durable responses in patients with low or no PD-L1 expression and in indications that typically do not respond to immune checkpoint therapy." INSIGHT-005 will be an investigator-initiated explorative, open-label study evaluating the safety and efficacy of Immutep’s lead product candidate, efti, in combination with avelumab in up to 30 patients with metastatic urothelial cancer. The study will take place in Germany. The first patient is expected to be enrolled and dosed in H1 of calendar year 2023, after completing the necessary ethics and regulatory steps. Under the Agreement, Immutep and Merck KGaA, Darmstadt, Germany will jointly fund the INSIGHT-005 study.
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