MEDI0680 (previously known as AMP-514) is an investigational immunotherapy being developed by AstraZeneca for the treatment of cancer. It is a monoclonal antibody that consists of a humanized immunoglobulin gamma 4 kappa (IgG4k) specific to programmed cell death-1 (PD-1) protein.
How MEDI0680 works
PD-1 is an immune checkpoint protein found on the surface of specialized immune cells called T-cells. PD-1 functions as a type of “off switch,” keeping the T-cells from attacking healthy cells in the body. The off switch is activated when a protein called PD-L1, found on the surface of healthy cells, binds to PD1. However, PD-L1 also exists in large quantities on the surface of some cancer cells, which helps them evade immune attacks.
MEDI0680 has potential immune checkpoint inhibitory and anticancer activities. After being administered, MEDI0680 binds to PD-1, inhibiting it and all its downstream signaling pathways. This may restore and boost the immune function through the activation of T-cells and cell-mediated immune responses against tumor cells.
A Phase 1 study (NCT02013804) evaluated the safety, tolerability, pharmacokinetics (how the drug moves in the body), immunogenicity (ability to trigger an immune response) and antitumor activity of MEDI0680 in adults with solid tumors. The results showed that MEDI0680 had an acceptable safety profile at a dose of 20mg/kg administered every two weeks, with preliminary signs of effectiveness.
A Phase 1/2 study (NCT02118337) is ongoing and still recruiting participants in the U.S. with select advanced malignancies to assess the safety and antitumor activity of MEDI0680 in combination with Imfinzi (durvalumab). Preliminary results showed that in 30 participants treated with six different doses of the drugs, a dose of 10 mg of MEDI0680 and 10 mg of Imfinzi appeared to be well-tolerated and active. The estimated study completion date is January 2021.
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