How MGA012 works
Upon administration, MGA012 targets a protein called PD-1 (programmed cell death 1) found on the surface of specialized immune cells called T-cells. This protein plays an important role in down-regulating, or dampening, the immune system, and is activated when another protein, called PD-L1, binds to it.
PD-L1 is made by healthy cells to ensure that the immune system does not mistakenly attack them. However, cancer cells can also express PD-L1, essentially highjacking this immune checkpoint and evading the immune response intended to protect the body from invaders.
The binding of MGA012 to PD-1 means that PD-L1 cannot bind to it. This results in the release of the immune system from restrictions imposed by tumors.
MGA012 in clinical trials
The safety and tolerability of MGA012 are currently being investigated in patients with solid tumors in an open-label, multi-center, Phase 1 (NCT03059823) dose-escalation and dose-expansion study.
The study’s primary goal to characterize the safety and tolerability of MGA012 and establish its maximum tolerated dose for future trials. To achieve this, MGA012 will be administered in two schedules: either every two weeks or every four weeks in patients with recurrent/drug resistant or advanced or metastatic solid tumors that cannot be removed with surgery.
Study investigators will also assess the pharmacokinetics (the movement inside the body), pharmacodynamics (the effect on the body), and anti-tumor activity of MGA012 in an estimated 125 patients with solid tumors. The safety of MGA012 will be evaluated based on the incidence of adverse events and serious adverse events that may occur from the time of administration through to the end of the study.
The study, which is currently recruiting patients at sites in Michigan, North Carolina and Texas, will be conducted in phases. In the initial phase, two dose schedules of single-agent MGA012 will be assessed at escalating doses. Once an ideal dose is established, more patients will be enrolled and assigned to dose expansion groups to assess the anti-tumor activity of MGA012 on specific tumor types.
MacroGenix is planning to further evaluate MGA012 both as a monotherapy and in combination with its other potential cancer treatments.
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