Promising Cancer Vaccine with Few Side Effects Moves Closer to Phase 3 Clinical Trials

Dr. Thomas Wagner, the brain behind Orbis Health Solutions, a biotech company, and a dedicated cancer researcher, has set out on a mission to tackle cancer without the nasty side effects that often accompany treatment. He's concerned that these side effects can sometimes be worse than the cancer itself and might even lead to an earlier demise.

Wagner shared with ABC News, "The tragedy of cancer is not just the person and the diagnosis, but also the fear of the therapy." Conventional cancer treatments, like chemotherapy, wipe out not only cancer cells but also healthy ones, causing side effects such as hair loss, nausea, and a weakened immune system.

Driven by witnessing patients suffer from the harsh effects of treatment, Wagner embarked on developing a cancer treatment that doesn't harm the immune system but harnesses its power. This innovative approach involves a personalized vaccine developed over decades. The vaccine uses a person's own tumor cells to train the immune system to identify and combat cancer cells.

Wagner, with over 60 years in the field, believes this method, coupled with early detection, could be the sought-after cure for all cancers. The vaccine, called the tumor lysate particle only (TLPO) vaccine, has shown promising results in Phase 2 clinical trials, particularly for advanced melanoma.

Recent data from an academic conference revealed that almost 95% of those solely receiving the vaccine were alive three years into treatment, with 64% remaining disease-free. The vaccine even demonstrated positive outcomes for stage III and IV melanoma cases.

However, caution is advised, as Phase 2 results don't guarantee success in the larger Phase 3 trials. Dr. Vernon Sondak, an oncologist, emphasized the need for further validation. The FDA has given the green light for a Phase 3 trial, a $100 million, three-year effort set to enroll 500 participants.

To overcome financial challenges, Wagner's team initiated a basket trial approved by the FDA. This trial allows the vaccine, proven successful in melanoma cases, to be tested in individuals with various solid tumors. Initial responses, like that of Catie King, an ovarian cancer patient, are positive, with minimal side effects.

Riley Polk, president of Orbis Health Solutions, hopes that the Phase 3 trial's data and the basket trial's success will attract larger pharmaceutical companies for partnerships. The road to widespread availability involves navigating through rigorous trials and approvals, requiring years and significant funding.

Wagner and his team remain optimistic, drawing inspiration from success stories like Mary Carol Abercrombie, who defied stage 4 melanoma odds over two decades. While the TLPO vaccine holds promise, its journey to becoming a widely accessible and approved cancer treatment is still underway.

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