Prima Biomed, an Australian biotechnology company developing immunotherapies for cancer and autoimmune diseases, announced it has received approval for the third cohort of its Phase 1 melanoma trial (NCT02676869), TACTI-mel.
The trial is being conducted in Australia and is actively recruiting patients for its third group, which will include a total of six patients with unresectable or metastatic melanoma.
This is an interventional study with the primary objective of determining the safety, tolerability, and recommended Phase 2 dose of a new drug called IMP321, combined with Keytruda (pembrolizumab) in patients with stage 3 or 4 melanoma.
Data from the study’s first patient group, released in December 2016, showed that administering IMP321 at 1 mg dose into melanoma patients was safe and well-tolerated. The first group included six patients who presented a suboptimal response when treated with Keytruda alone. Two out of six patients (33%) showed a partial or complete radiological tumor response when Keytruda therapy was combined with 1 mg of IMP321.
The TACTI-mel study is a multi-center, open label (meaning that both the researchers and participants know which treatment is being administered), dose-escalation study in which patients with unresectable or metastatic melanoma receive single escalating doses of IMP321 – 1 mg (group 1), 6 mg (group 2), or 30 mg (group 3) – administered every two weeks, and in combination with Keytruda.
Researchers in the trial will evaluate the treatment safety as a primary goal. Secondary goals will include anti-tumor activity and the immune response created by the combined therapy of IMP321 and Keytruda.
IMP321 is a soluble form of the immune checkpoint molecule LAG3. When administered into patients it activates the so-called antigen presenting cells, which are immune cells that guide T-cells to their targets. This means the drug is capable of boosting the immune response of cancer patients.
Keytruda is an anti-PD-1 immune checkpoint inhibitor, which means it targets and blocks a protein called PD-1 on the surface of immune cells, called T-cells, which enhances their ability to find and kill cancer cells.
The study is recruiting participants. More information can be found here.