Personalised cancer vaccine with minimal side effects nearing Phase 3 clinical trials

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ORBIS Health Solutions is working on a cancer vaccine. Dr. Thomas Wagner, founder of the biotech company Orbis Health Solutions and cancer researcher, has made it his life’s mission to find a way to treat cancer without the dreaded side effects that, for some, can become worse than the cancer itself or may even lead to an earlier death.

“The tragedy of cancer is not just that person, the diagnosis, but it’s also the fear of the therapy,” Wagner told ABC News. Many traditional cancer treatments, such as chemotherapy, work by killing off cancer cells but also kill off non- cancerous cells throughout the body. This can cause a range of side effects including hair loss, nausea, vomiting, or may knock out a person’s immune system putting them at risk of lifethreatening infections, Wagner said.

After seeing cancer patients suffer from debilitating side effects of their treatment, Wagner began his mission to develop a cancer treatment that harnessed the power of a person’s immune system instead of eliminating it. This treatment was developed as a vaccine that has now been studied for decades, and each shot is completely personalized to each patient.

Typically, cancer cells evade a person’s immune system because it is recognized as that person’s cells. Wagner developed a tumor lysate particle only ( TLPO) vaccine that uses a person’s tumor cells to identify particular parts that are then presented back in the body using the vaccine in a way that can stimulate their immune system to gain the ability to detect these cancer cells like an infection, allowing the immune system to fight the cancer itself.

“People used to ask me the question, ‘ When will there be a cure for cancer?’ And I’ve been doing this for 60 years and I could never answer that question,” Wagner said. “Until recently, until the last three or four or five years.”

Wagner believes this type of cancer treatment could be a key to finding the longawaited cure for cancer, all cancers, if paired with early detection.

Wagner’s TLPO cancer vaccine has been tested in hundreds of patients with advanced forms of melanoma in Phase 2 clinical trials.

The most recent data presented at an academic conference showed nearly 95 per cent of people given only the vaccine were still alive three years after starting treatment and 64 per cent were still disease- free. Among the most advanced forms of melanoma, disease- free survival after three years for people with stage III disease was 60 per cent in the vaccine- only group, compared to about 39 per cent in the placebo group. Diseasefree survival for those with stage IV disease was about 68 per cent in the vaccine- only group, and zero in the placebo group.

The most common side effects were redness or pain at the injection site, fever and fatigue after the injection – similar to other vaccines that stimulate an immune response.

Dr. Vernon Sondak, cutaneous oncologist at Moffitt Cancer Center who was not involved in the clinical trial but has worked with tumor lysate vaccines throughout his career, told ABC News that these results are promising, but point out that the Phase 2 clinical trials aren’t conclusive. A larger Phase 3 clinical trial will have to ultimately validate if this cancer vaccine will truly be a game- changer in the field.

“We’ve seen over and over again, promising Phase 2 data that didn’t turn out to be so promising in Phase 3,” Sondak cautions.

Based on this data and other studies, the Food and Drug Administration ( FDA) has greenlit Wagner’s vaccine to start a Phase 3 clinical trial. It will be a three- year endeavor with a goal to enroll 500 people and is planned to launch sometime this year, Riley Polk, president of Orbis Health Solutions, told WLOS, an ABC News affiliate in Asheville, North Carolina.

Polk said he has been personally impacted by the success of this vaccine after his father went through numerous lung surgeries for cancer over a decade ago but was left with no other treatment options. His father opted to try Wagner’s cancer vaccine and lived 10 more years before dying from something unrelated to cancer. “You can tell me a lot of things, but you can’t tell me [ the vaccine] doesn’t work,” Polk said.