ADU-741 is an investigative immunotherapy by Aduro Biotech for advanced castration-resistant prostate cancer. It is the focus of a Phase 1 clinical trial sponsored by Janssen Biotech, Aduro’s license partner for the compound.

The therapy (also called JNJ-64041809) is a  live-attenuated, double-deleted (LADD) strain of the gram-positive bacteria Listeria monocytogenes that encodes for antigens or molecular signals capable of triggering an immune response associated with different cancers.

Aduro’s ADU-741 has the potential to activate the immune system to recognize and destroy existing tumors as well as prevent the formation of new ones, especially in prostate cancer.

How ADU-741 works

ADU-741 works by stimulating the immune system to fight cancer. The LADD platform is based on engineered strains of Listeria monocytogenes that express tumor antigens, causing a specific and targeted immune response against the tumor.

Two genes that make the bacteria harmful by controlling the infection of cells and the growth of more bacteria are removed, making it safe to use without compromising its benefits.

The attenuated bacteria is further modified with the addition of new genetic material which code for specific tumor antigens. Those antigens activate immune cells called antigen-presenting cells (APCs), triggering an immune response.

Some of the benefits of LADD as an immunotherapy are that it prompts an innate immune response after being injected into the bloodstream by activating multiple sensing receptors found on the surface of immune cells while being well-tolerated by patients.

It can be combined with chemotherapy or other treatments. It can also be engineered to produce one or more tumor antigens and is not neutralized by the patient’s immune system, allowing it to be injected several times.

ADU-741 in clinical trials

A Phase 1 clinical trial (NCT02625857) is investigating the optimum dose of ADU-741 in people with metastatic castration-resistant prostate cancer. The initial dose-escalating portion of the study with two dose levels of ADU-741 will evaluate safety and immunogenicity. The trial will then be expanded to evaluate the safety and preliminary immunological and clinical activity of ADU-741. The trial has suspended participant recruitment. The estimated primary completion date is January 2018.

A Phase 2 study (NCT02906605) has also been initiated but then withdrawn prior to enrollment due to pending collection and analysis of additional data from the Phase 1 study.

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