How AMG 330 works
AML is a cancer that originates in the bone marrow. It is caused by early versions of blood cells, called myeloid cells, multiplying out of control and behaving abnormally. It progresses quickly if not treated.
Usually the immune system is capable of recognizing abnormal cells, such as cancer cells, and directing immune cells such as T-cells to destroy them. But some tumor cells develop mechanisms to evade immune system detection.
AMG 330 is an immunotherapy, which means that it does not directly target a tumor but instead tries to prompt the immune system to attack cells producing a certain protein. Amgen uses its proprietary bispecific T-cell engager technology to produce the therapy. AMG 330 consists of a protein with two sections fused together so it can interact with two targets — CD33 and CD3.
AML tumor cells produce a protein called CD33. CD3 is found on the surface of T-cells. When AMG 330 binds to both CD33 on the tumor cell and CD3 on the T-cell, the T-cell is able to recognize and trigger the death of the tumor cells. The goal is to reduce the size of the tumor and slow the progression of AML.
AMG 330 in clinical trials
Amgen is conducting a Phase 1 clinical trial (NCT02520427) of AMG 330. It is investigating the safety of different doses of the therapy and patients’ ability to tolerate it. It is also assessing AMG 330’s pharmacokinetics, or how the body breaks down the drug, and pharmacodynamics, or how the drug acts on the body.
In addition, researchers are doing a preliminary assessment of AMG-330’s anti-tumor activity. The main effectiveness yardsticks will be patients’ response to the treatment and the duration of a response. Participants will be monitored for up to three years for any adverse events resulting from treatment.
Researchers are continuing to enroll participants for the study at seven sites across the United States, Germany and the Netherlands. The goal is to recruit 50 people with AML that has returned or failed to respond to standard treatment.
AMG 330 is administered through injection into a vein.
Amgen has signed an agreement with Ligand that grants Amgen the right to use Captisol (modified cyclodextrin) in combination with AMG 330. Captisol improves the solubility and stability of other drugs.
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