IMP321, Keytruda Combo Trial Receives OK to Open Last Patient Group

IMP321, Keytruda Combo Trial Receives OK to Open Last Patient Group

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.

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