ADXS-HER2 is an immunotherapy that Advaxis is developing to combat bone and other cancers that generate a protein called HER2.

In April 2016 the U.S. Food and Drug Administration approved Fast Track designation for ADXS-HER2 as a treatment for a rare bone cancer. The designation covered newly diagnosed, surgically removable osteosarcoma that had not spread to other parts of the body. ADXS-HER2 has also received orphan drug designation from the FDA and the European Medicine Agency as a treatment for osteosarcoma.

Fast Track status accelerates a therapy’s FDA approval. Orphan drug status gives treatment developers incentives to create therapies for rare diseases.

How ADXS-HER2 works

Some solid tumors, including bone cancer, produce excessive amounts of HER2, making the protein a target for immunotherapy. In addition to bone cancer, the overproduction occurs in breast, gastric, bladder, brain, pancreatic, and ovarian cancer. Excessive production of HER2 is associated with a more aggressive cancer, an increased risk that it will return after treatment, and shorter patient survival times.

Advaxis used its Lm Technology platform to create ADXS-HER2, which activates the body’s immune system to fight cancer containing HER2.

At the heart of the therapy is a version of the Listeria monocytogenes bacteria that Adaxis scientists engineered to be weaker than the naturally occurring strain. Contact between listeria and antigen-presenting immune cells in the body prompts another type of immune cell — T-cells — to begin fighting cancer.

ADXS-HER2 in clinical trial

A preclinical-trial study showed that ADXS-HER2 more than doubled the survival time of dogs whose bone cancer had been removed with surgery. The therapy triggered an immune response designed to keep the cancer from returning.

Dogs treated with ADXS-HER2 lived an average of 956 days after surgery, compared with 423 days in dogs that had surgery alone. ADXS-HER2 also led to fewer instances of the cancer spreading to other parts of the body, compared with the control dogs.

Advaxis is conducting its first clinical trial of ADXS-HER2. Patients in the Phase 1b study have HER2-generating solid tumors that have spread to other parts of the body.

Researchers are evaluating the safety of different doses of ADXS-HER2 and patients’ ability to tolerate them. The team will use the results to determine the direction of additional trials.


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