Sydney-based Immutep (ASX:IMM), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, has announced that the first patient in the INSIGHT-004 phase 1 clinical trial has been enrolled in Germany and has received the first dose of treatment.
INSIGHT-004 is being conducted in collaboration with Merck KGaA and Pfizer. The study is evaluating the safety, tolerability and recommended phase 2 dose of Immutep’s lead immunotherapy product candidate eftilagimod alpha when administered in combination with BAVENCIO (avelumab) in 12 patients with advanced solid malignancies. Overall response rate according to RECIST 1.1 is the primary efficacy endpoint.
Patients will receive 800mg avelumab intravenously and either 6mg or 30mg of IMP321 by subcutaneous injections, once every two weeks for up to 12 cycles. Thereafter, patients may move into the maintenance phase to continue to receive avelumab monotherapy once every two weeks for a further 12 cycles
Avelumab is an anti-PD-L1 therapy being co-developed and co-commercialised by Merck and Pfizer.
The Institute of Clinical Cancer Research in Frankfurt is the sponsor of the clinical trial which is being conducted under the protocol of the ongoing INSIGHT clinical study, with lead investigator Professor Dr Salah-Eddin Al-Batran
“INSIGHT-004 aims to address two separate parts of the cancer immunity cycle. As an anti-PD-L1 therapy, avelumab works in part by releasing the brakes of the body’s immune system, while efti is a first-in-class antigen presenting cell activator that pushes the accelerator of the patient’s immune system. Our hope is the combination treatment is safe and patients with advanced solid cancers benefit,” said Professor Dr Al-Batran
“The commencement of our INSIGHT-004 trial in Germany is exciting as this is a new study with our collaboration partners Merck KGaA, Darmstadt, Germany, and Pfizer. Patient recruitment will continue in Germany and we look forward to the first data in 2019,” said Immutep CSO and CMO, Dr Frederic Triebel.