Cancer Vaccine with Few Side Effects Approaches Phase 3 Clinical Trials

Cancer Vaccine with Few Side Effects Approaches Phase 3 Clinical Trials

Renowned cancer researcher and founder of biotech company Orbis Health Solutions, Dr. Thomas Wagner, has dedicated his life's work to revolutionizing cancer treatment. His mission is to alleviate the debilitating side effects associated with conventional therapies, which, for some individuals, can be more distressing than the cancer itself and may even hasten death.

Wagner, in an interview with ABC News, expressed that the tragedy of cancer extends beyond the diagnosis, encompassing the anxiety induced by the therapy itself. Conventional treatments like chemotherapy indiscriminately target both cancer and healthy cells, leading to adverse reactions such as hair loss, nausea, vomiting, and compromised immunity, putting patients at risk of severe infections.

Witnessing the profound suffering of cancer patients prompted Wagner to embark on a quest for a treatment that harnesses the body's immune system instead of suppressing it. This innovative approach materialized as a personalized vaccine, studied for decades, utilizing a tumor lysate particle only (TLPO).

Traditionally, cancer cells evade the immune system by mimicking the host's cells. Wagner's TLPO vaccine uses a person's tumor cells to identify specific components. These components are reintroduced into the body via the vaccine, prompting the immune system to recognize and combat cancer cells akin to an infection.

Wagner, with over 60 years in the field, believes this groundbreaking treatment, coupled with early detection, could be the elusive cure for various cancers.

Recent data from Phase 2 clinical trials involving Wagner's TLPO cancer vaccine, primarily tested on advanced melanoma patients, is promising. Nearly 95% of those receiving only the vaccine remained alive three years into treatment, with 64% remaining disease-free. Notably, patients with stage III melanoma had a 60% disease-free survival rate compared to 39% in the placebo group, and those with stage IV disease achieved a 68% disease-free survival compared to zero in the placebo group.

While these results are encouraging, Dr. Vernon Sondak, a cutaneous oncologist at Moffit Cancer Center, emphasizes that Phase 2 trials are not conclusive. The true impact of the vaccine must be validated through a larger Phase 3 clinical trial.

The Food and Drug Administration (FDA), recognizing the potential, has approved Wagner's vaccine for a Phase 3 trial. This three-year initiative, set to enroll 500 participants, aims to begin this year. Riley Polk, president of Orbis Health Solutions, revealed that the Phase 3 trial is a $100 million project, underscoring the financial challenges faced by smaller companies.

To overcome funding limitations, Wagner initiated a basket trial, allowing the TLPO vaccine's testing in individuals with various solid tumors. The initial participant, Catie King, diagnosed with ovarian cancer, reported minimal side effects, highlighting the vaccine's positive impact on her well-being.


Polk hopes the data from the basket trial attracts larger pharmaceutical companies. Collaborations and additional funding mechanisms could facilitate more extensive trials through FDA approval.


The potential of Wagner's cancer vaccine has already transformed lives, offering hope to patients who experienced minimal side effects and significant improvements in their quality of life. As this innovative treatment progresses through clinical trials, the prospect of a revolutionary and side-effect-minimized cancer therapy comes closer to reality.




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