A personalized cancer vaccine developed over six decades is now entering Phase 3 clinical trials — and its most striking feature may not be how well it works, but how little it hurts. The tumor lysate particle only (TLPO) vaccine, created by Dr. Thomas Wagner and his company Orbis Health Solutions, showed that nearly 95% of advanced melanoma patients given only the vaccine were still alive three years after starting treatment.
At a glance
- TLPO vaccine: Each shot is fully personalized, made from a patient’s own tumor cells to train their immune system to detect and fight the cancer.
- Phase 3 trial: The U.S. Food and Drug Administration has approved a three-year trial aiming to enroll 500 melanoma patients, planned to launch in 2024 C.E.
- Basket trial: A parallel FDA-approved basket trial is now testing the same vaccine in patients with solid tumors across brain, lung, breast, and ovarian cancers.
How the vaccine works
Cancer cells typically evade the immune system because they are recognized as the body’s own tissue. Wagner’s vaccine changes that equation.
The TLPO approach takes cells from a patient’s own tumor, identifies specific markers, and reintroduces them into the body in a way that flags cancer as a threat — much like a pathogen the immune system should attack. The result is a treatment that activates the body’s defenses rather than suppressing them, which is the mechanism behind most chemotherapy.
“The tragedy of cancer is not just that person, the diagnosis, but it’s also the fear of the therapy,” Wagner told ABC News. He has spent 60 years in cancer research, and said it is only in the last few years that he has felt able to answer the question people have asked him his whole career: when will there be a cure?
What the data shows
Phase 2 clinical trials tested the vaccine in hundreds of patients with advanced melanoma. The results, presented at an academic conference, were striking.
Among patients with stage IV melanoma — the most advanced form — disease-free survival at three years was approximately 68% in the vaccine-only group. In the placebo group, it was zero. For stage III patients, disease-free survival was 60% in the vaccine group versus about 39% in the placebo group.
Side effects were limited almost entirely to redness or pain at the injection site, mild fever, and fatigue — responses typical of any immune-stimulating vaccine. No hair loss. No nausea. No immune system collapse.
One of the longest-documented survivors is Mary Carol Abercrombie, diagnosed with stage 4 melanoma in 2001 C.E. After a year of conventional treatment with what she described as “horrendous” side effects, her cancer advanced and her doctors told her she had months to live. She enrolled in Wagner’s vaccine trial, hoping only to survive long enough to see her son’s wedding. More than 20 years later, her melanoma has never recurred, and she is watching four grandchildren grow up.
From melanoma to all solid tumors
Building on the melanoma results, Wagner’s team has launched a basket trial — an FDA-approved format that allows the same vaccine to be tested across any solid tumor type, provided patients meet certain criteria. Most participants will have already received prior treatment and carry a low or minimal tumor burden.
The first participant was Catie King, an Asheville, North Carolina farmer diagnosed with ovarian cancer six years ago. After her first round of the vaccine, she reported feeling well — with only minor redness at the injection site. “With this vaccine, there haven’t been any hard days,” she said, contrasting it sharply with her earlier experience on low-dose chemotherapy.
Six additional patients with brain, lung, and breast cancer have since joined the basket trial. Riley Polk, president of Orbis Health Solutions, said he has a personal stake in the outcome: his father, left with no options after multiple lung surgeries, tried Wagner’s vaccine and lived 10 more years before dying of causes unrelated to cancer.
The road ahead is long — and expensive
The Phase 3 trial carries a price tag of roughly $100 million. For a smaller private company like Orbis, that is a significant barrier. Polk has said he hopes data from the basket trial will attract partnerships with larger pharmaceutical companies capable of funding broader clinical programs.
Dr. Vernon Sondak, a cutaneous oncologist at Moffitt Cancer Center who has worked with tumor lysate vaccines throughout his career, called the Phase 2 results promising — but offered a necessary caution. “We’ve seen over and over again, promising Phase 2 data that didn’t turn out to be so promising in Phase 3,” he told ABC News. The larger trial will be the true test.
Even if Phase 3 succeeds, FDA approval and broader access will take additional years and hundreds of millions more in funding. For patients with cancers beyond melanoma, the path runs through more basket trial data, then condition-specific trials — a process measured in years, not months. The promise is real, but so is the distance still to travel.
Read more
For more on this story, see: ABC News
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