ABBV-428 is an investigational antibody-based cancer therapy being developed by Abbvie. It is currently being studied to possibly treat solid tumors.

How ABBV-428 works

ABBV-428 is a novel antibody designed to stimulate the CD40 ligand and set in motion an immune response against cancer cells.

It works by stimulating a protein called CD40 ligand or CD40L that is present on the surface T-cells, specialized cells of the immune  system. This protein interacts with a receptor protein called CD40 that is found on the surface of other immune cells, such as B-cells. The interaction of CD40L with CD40 induces both the activation and proliferation of T-cells, which play a role in killing such abnormal cells as cancer.

An antibody that stimulates CD40L, such as ABBV-428, could potentially stimulate T-cells, resulting in an enhanced immune response against cancer cells.

ABBV-428 in clinical trials

An open-label, multicenter, dose-escalation Phase 1 study (NCT02955251) is currently evaluating the safety and pharmacokinetics (movement in the body) of ABBV-428 when administered as a single agent or in combination with Opdivo (nivolumab) in patients with advanced solid tumors.

Opdivo is an antibody that binds to a protein called PD-1 also found on T-cells, and promotes the immune attack that aims to kill cancer cells.

The trial’s main objectives include identifying a recommended dose for future Phase 2 studies and a maximum tolerable dose. Adults being enrolled have advanced cancer that has progressed while on standard treatments.

It consists of two phases: one dose-escalation and the those dose-expansion, with ABBV-428 studied as a single agent and in combination with Opdivo in each phase.

In the dose-escalation part, ABBV-428 will be injected at escalating doses into patients’ bloodstream on days 1 and 15 of 28-day cycles. The dose of ABBV-428 determined as best will then be tested in combination with Opdivo on approved dosing cycle.  In the dose-expansion part, additional patients with different types of solid tumors will be enrolled to further evaluate ABBV-428. A number of additional NSCLC patients will be in the subgroup further evaluating ABBV-428 in combination with Opdivo.

The study is currently recruiting about 172 participants in the U.S., Australia, and France. It is expected to conclude in July 2019.


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