JNJ-663709178 is an investigational immunotherapy to treat acute myeloid leukemia (AML). It is being developed by Genmab in collaboration with Janssen.

How JNJ-63709178 works

AML is a cancer caused by the abnormal growth and behavior of some early forms of blood cells in the bone marrow. It can progress very quickly if not treated.

A type of immunotherapy, JNJ-63709178 aims to help the immune system recognize and fight cancer cells. It acts to promote the activity of T-cells, an immune system cell that has the ability to identify and kill abnormal cells, such as tumor cells.

JNJ-63709178 is a bispecific antibody, or a protein designed to interact with two specific targets (antigens), developed using Genmab’s DuoBody technology. As a bispecific antibody, JNJ-63709178 has two binding sites to recognize two separate targets — CD123 and CD3.

CD3 is found on the surface of T- cells and involved in their activation to recognize and attack a specific target.

CD123 is part of the interleukin-3 (IL-3) protein that is commonly overproduced by certain cancers, including AML, and is rarely found on healthy cells. Excessive production of CD123 is associated with increased survival and proliferation of tumor cells.

By simultaneously binding to both CD123 and CD3, JNJ-63709178 crosslinks T-cells and tumor cells. This can activate the T-cells to recognize and attack tumor cells, slowing the progression of the cancer and potentially reducing tumor size.

Preclinical studies of JNJ-63709178 in mouse cancer models demonstrated it can activate T-cells specifically in the presence of CD123-positive tumor cells and lead to a reduction in tumor size.

JNJ-63709178 in clinical trials

Janssen initiated a first-in-human Phase 1 dose-escalation clinical trial (NCT02715011) with the aim of determining a recommended dose and schedule for JNJ-63709178 that can be used in Phase 2 studies. Participants will be monitored for adverse events caused by the treatment for up to 1.5 years to assess its safety and tolerability. Evidence of an immune response and the treatment’s possible anti-tumor activity is being assessed by measuring patients’ overall response rate (ORR).

In September 2016, Safety concerns resulted in the trial being suspended following a serious adverse event in one participant in August 2016, but Janssen resumed recruitment in April 2017. The trial aims to recruit 60 patients whose AML has recurred or is not responding to standard treatment. It is enrolling, or due to start enrolling, at sites in the U.S. and Spain.


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