Promising Cancer Vaccine, Few Side Effects Heading Toward Phase 3 Trials

  Heading Toward Phase 3 Trials

Dr. Thomas Wagner, the brains behind Orbis Health Solutions, a biotech company, and a cancer researcher, has dedicated his life to a unique mission: finding a way to treat cancer without the harsh side effects that often make the cure feel worse than the disease itself and, in some cases, lead to an untimely demise.

Wagner, in an interview with ABC News, expressed his belief that the tragedy of cancer isn't just the diagnosis itself but also the fear that comes with the treatment. Conventional methods like chemotherapy, while effective in killing cancer cells, also harm healthy cells, causing side effects like hair loss, nausea, vomiting, and compromising the immune system, making patients vulnerable to severe infections.

Moved by the suffering of cancer patients enduring these side effects, Wagner embarked on a mission to create a cancer treatment that wouldn't obliterate the immune system but instead leverage its power. His solution? A personalized vaccine studied for decades, targeting the Campylobacter genus of bacteria, specifically C. jejuni and C. coli, often transmitted to humans through animal products.

Traditional cancer cells usually go unnoticed by the immune system as they are recognized as the body's own cells. Wagner devised a tumor lysate particle-only (TLPO) vaccine that employs a person's tumor cells to identify specific parts. This information is then presented back to the body using the vaccine, triggering an immune response that enables the immune system to recognize and combat cancer cells.

Wagner believes this immune-focused cancer treatment, when coupled with early detection, could be the much-anticipated breakthrough in the quest for a cancer cure. The TLPO vaccine has shown promising results in Phase 2 clinical trials, particularly in advanced melanoma cases.

Recent data revealed that nearly 95% of those solely receiving the vaccine were alive three years into treatment, with 64% remaining disease-free. In cases of stage III melanoma, the vaccine-only group showed a 60% disease-free survival rate after three years, compared to 39% in the placebo group. For stage IV disease, the vaccine-only group had a 68% disease-free survival rate, while the placebo group showed zero.

While these results are promising, Dr. Vernon Sondak, a cutaneous oncologist at Moffit Cancer Center, cautioned that Phase 2 trials aren't conclusive, and a larger Phase 3 trial is necessary for validation. The Food and Drug Administration (FDA) has given the green light for a Phase 3 clinical trial, set to launch later this year, with a goal to enroll 500 participants over three years.

However, financial barriers pose a challenge. The Phase 3 clinical trial requires a substantial $100 million investment, a significant hurdle for smaller private companies like Orbis Health Solutions. To overcome this, Wagner initiated a basket trial, allowing the vaccine to be tested in individuals with solid tumors meeting specific criteria. The hope is that successful results will attract attention from larger pharmaceutical companies, opening avenues for more extensive trials.

Patients who received the vaccine in earlier trials reported minimal side effects, such as redness or pain at the injection site, fever, and fatigue—similar to reactions from other immune-stimulating vaccines. One patient from Asheville, North Carolina, participating in the basket trial, shared her positive experience, highlighting the lack of hard days compared to previous low-dose chemotherapy treatments.

The road to widespread availability of the vaccine involves showcasing success in the Phase 3 clinical trial, obtaining FDA approval, and undergoing additional trials for various indications. The journey is long and requires significant funding, but the potential impact on cancer treatment and patients' lives is driving the effort forward.

Dr. Jade A. Cobern, MD, MPH, a board-certified pediatrician specializing in preventive medicine and a fellow of the ABC News Medical Unit, contributed to this report, along with Justin Berger, a reporter from WLOS, an ABC News affiliate in Asheville, North Carolina.

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