(ASX:IMM), an Australian biotechnology company developing novel immunotherapy treatments for cancer, infectious disease and autoimmune disease, has announced a second clinical trial collaboration and supply agreement with MSD.
The new collaboration will involve a new Phase 2b clinical trial of Immutep’s eftilagimod alpha (efti or IMP321) in combination with MSD’s KEYTRUDA (pembrolizumab).
The trial, which is called TACTI-003 (Two Active Immunotherapies), will test the combination as a first-line treatment of patients with head and neck squamous cell carcinoma (HNSCC), compared to KEYTRUDA alone. The trial will involve approximately 160 patients and take place in sites in the US, Australia and Europe. The first patient is expected to be enrolled in mid-2021.
HNSCC is the sixth most common cancer by incidence worldwide, with 890,000 new cases and 450,000 deaths reported in 2018. It is an aggressive, genetically complex and difficult to treat cancer.
The combination is also being evaluated in another ongoing phase two trial (TACTI-002). The company said that “promising clinical results” from this trial prompted the initiation of the new TACTI-003 trial.
“The combination brings together two immuno-oncology treatments with complementary mechanisms of action at two different positions in the cancer immunity cycle. Efti is a first-in-class antigen-presenting cell activator which stimulates cancer-fighting T cells, while KEYTRUDA is an anti-PD-1 therapy which blocks the immunosuppressive PD-1 pathway,” said Immutep.
“We are excited to be deepening our collaboration with MSD through this second agreement and the TACTI-003 clinical trial. Advancing to this later stage Phase IIb trial will allow us to explore the combination therapy in the commercially relevant 1st line therapy setting which has a high unmet medical need,” said Immutep CEO Marc Voigt.