It has entered into a second clinical trial collaboration agreement with Merck KGaA, Germany, and Pfizer Inc for new combination study of its LAG-3 candidate, eftilagimod alpha, with avelumab.
INSIGHT-005 will evaluate the safety and efficacy of eftilagimod alpha (efti) and avelumab (BAVENCIO) in up to 30 patients with urothelial cancer.
In 2018, both Merck KGaA and Pfizer became collaboration partners of Immutep to facilitate the evaluation of efti in combination with avelumab, a human anti-PD-L1 antibody that is a stimulator of the immune system to detect and fight tumor cells, in patients with advanced solid tumors.
Immutep CEO, Marc Voigt, said 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."
Under the new agreement, Immutep and Merck KGaA will jointly fund INSIGHT-005. It will be an investigator-initiated explorative, open-label study, and will take place in Germany, run by the Institute of Clinical Cancer Research, Krankenhaus Nordwest (IKF).
The first patient is expected to be enrolled and dosed in H1 of calendar year 2023, after completing the necessary ethics and regulatory steps.
Efti was previously evaluated in combination with avelumab via the INSIGHT-004 study in patients with advanced solid cancers, including colorectal, pleural mesothelioma, squamous anal cell, cervical, and gastroesophageal carcinomas.
Immutep announced final data from that project in June 2021, reporting encouraging efficacy signals from the combination with a response rate of 41.7% according to RECIST 1.1.
Efti is Immutep’s soluble LAG-3 clinical stage candidate, an antigen-presenting cell (APC) activator for the treatment of cancer, capitalising on LAG-3’s characteristics to stimulate both innate and adaptive immunity.
The company said Efti binds to and activates antigen-presenting cells via MHC II molecules leading to expansion and proliferation of CD8+ (cytotoxic) T cells, CD4+ (helper) T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like CXCL10 that further boost the immune system’s ability to fight cancer, claimed the Australian developer.
Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and HER2–/HR+ metastatic breast cancer. "Its favorable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy."
Efti has received Fast Track Designation in first-line HNSCC and in first-line NSCLC from the US Food and Drug Administration (FDA).