The Suit Magazine

Concentrating on the fight against cancer, Advaxis has successfully completed one clinical trial of a vaccine for cervical cancer. And it has vaccines in various stages of clinical development for cervical dysplasia, head & neck cancer, breast cancer, prostate cancer and brain cancer. It is poised to become, either on its own or in partnership with another pharmaceutical firm, a major player in the industry.

The company, founded seven years ago, has utilized the ground-breaking discoveries of Dr. Yvonne Patterson regarding the Listeria bacterium, and its use as a platform to deliver antigens to tumor sites. Patterson, a Professor of Microbiology, Associate Dean for Postdoctoral Research, and the Director of Biomedical Postdoctoral Programs at the University of Pennsylvania, has been working with the Listeria bacterium for some twenty years. Like many scientific explorers, Patterson did not originally set out to investigate Listeria.

In an exclusive interview with The Suit Magazine, Patterson explained, “I had been working on t-cell immune-responses and how t-cells recognize antigens and are stimulated by them. I was a basic immunologist, but, when I came to the [University of Pennsylvania’s] microbiology department, I was exposed to the research being done on bacteria and viruses.”

“One [bacterium] that particularly peaked my interest was Listeria, from the way that it could infect phagocytic cells,” she continued. “From an immunologist’s point of view, these are the cells that are responsible for starting the immune response by presenting the t-cells with antigens. This bug had the ability, once it colonized, to stimulate the cell’s Cytokins [small cell-signaling protein molecules that are secreted by numerous cells of the immune system].” Patterson then came up with an incredible insight. “I thought of using Listeria to convey
foreign antigens to the immune system.”

Over the next ten years she refined the process. She said, “[Listeria] was so much more effective [in mice] than other cancer treatments available, so I put all my efforts into cancer.” She attenuated Listeria in order to make it less disease-prone, and she modified it to create tumor antigens. Tumor cells are mutated body cells that mutate slowly, so the body doesn’t recognize them as foreign. Listeria acts as a wakeup call for many different immune mechanisms.

By 2003, with the help of the University, Advaxis was founded in order to develop Listeria as a medical platform. At the helm of the ship for Advaxis are Thomas A. Moore, Chairman and CEO, and Dr. John Rothman, Executive V.P. of Science and Operations. Moore, a graduate of Princeton University, served for 23 years with the Proctor & Gamble Company, holding multiple positions including President of Health Care Products and Group Vice President of the entire company. Prior to joining Advaxis he was President and CEO of Biopure Corporation. Rothman also worked as Senior Director for the Roche Group., with an emphasis on research and development, as well as additional heavyweight pharma experience. With their leadership Advaxis has turned Patterson’s scientific dreams into a reality, and the company currently holds 29 patents, with another 40 in process.
Cervical cancer was the initial target of application for Listeria. “Cervical cancer was something I had worked with a lot in the lab; it is a big viral protein, so it was easier to target,” Patterson explained. The first clinical trial of Listeria involved fifteen patients with either Stage IV advanced, recurrent, or progressive cervical cancer. “It was the first time anybody had ever given another human being live listeria, so we were very cautious,” Rothman stated. “For example, we gave two doses rather than our therapeutic regimen of three. We kept our subjects in the hospital for five days. None of that was really necessary. These were terminally ill cancer patients who had an average life expectancy of six months.” Patients were observed for a total of 111 days. The results were positive. Patterson told us, “We were able to double the median lifespan, and two of our subjects had their tumors disappear entirely.” Phenomenal results.

There are currently four other phase I/II trials – one for Cervical dysplasia, two for Cervical cancer, and one for Head & Neck cancer. According to a recent shareholders’ statement issued by Moore, “Our U.S. phase II cervical dysplasia study (120 patients) is on track. The first three patient cohort is completewith all three dose regimen having had with no side effects in any patient. Recruitment of the next cohort of seven is slated for completion over the next 30-45 days with the first dosing leg expected to be reported by next September 2011 as promised. This market is extremely important to Advaxis as cervical dysplasia is diagnosed in approximately 500,000 women annually in the U.S. alone. This is more than prostate and breast cancer combined.”

One of the other phase II Cervical cancer trials involves a 110-patient study being conducted in India. According to the shareholders’ statement, “The doses are already at the centers in India and are ready to go with government testing of our product…we expect to begin reporting survival data this coming Spring of 2011. If we match our Phase I results, but this time using three doses instead of two, we will create a true milestone in the treatment of cancer.”

Both a 63-patient trial as part of the U.S. National Cancer Institute study in cervical cancer, and a 45-patient trial as part of the Cancer Research U.K. studies in Head and Neck cancer are “funded and should be underway soon,” according to the statement. Trials involving Her2/neu (breast cancer, 24 patients), as well as PSA (prostate cancer, 30 patients) are planned to begin in 2011. A study involving brain cancer (30 patients) is also underway.

Other vaccines in early development include treatments for: Ovarian cancer, Glioma, lymphomas, leukemias, angiogenesis inhibitors and others. Dr. Patterson proudly told us that, “Advaxis is also doing work on veterinary vaccines.” The company is moving forward with veterinary programs at the University of Pennsylvania in canine osteosarcoma and as part of the U.S. Department of Homeland Security research into bovine hoof and mouth disease. Listeria has proven to be a quite remarkable bacterium, capable of mobilizing our own immune system, and carrying antigens in order to fight specific diseases. And Advaxis is well on the way to adding it to our arsenal of proven medical alternatives. As Moore stated in the shareholders’ report, “the company is moving forward across a broad range of fronts.”

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