NUNZIUM

Barbara Brigham was diagnosed with pancreatic cancer in September 2020, a disease with an 88% fatality rate and notorious for its difficulty to treat. Now cancer-free, Brigham credits an experimental personalized cancer vaccine by BioNTech. The results of this groundbreaking study were published in Nature.

The study involved 16 participants, with 8 responding positively to the vaccine. These responders produced T-cells that attacked their tumors and persisted for at least two years. Dr. Vinod Balachandran, a cancer surgeon at Memorial Sloan Kettering Cancer Center, led the study, which aimed to test the safety and feasibility of the therapy. Plans for larger clinical trials are in progress.

Creating the personalized vaccine involved sequencing the genetic code from tumors and patients' blood, identifying altered genes, and creating personalized mRNA vaccines. Patients received eight doses of the vaccine, followed by six months of chemotherapy and a final booster. The vaccine was infused into the bloodstream to stimulate a different part of the immune system, where T-cells were made.

Not all participants developed an adequate pool of programmed T-cells in response to the vaccine. Researchers theorize that the removal of the spleen may affect the vaccine response. A larger trial is needed to determine statistical significance.

The mRNA vaccines were tested as a treatment for pancreatic cancer at Memorial Sloan Kettering Cancer Center, with Dr. Balachandran leading the first clinical trial. Phase 1 trial results were reported on May 10 in Nature. Of the 16 patients, 8 showed activated T cells and delayed recurrence of pancreatic cancers. A larger, randomized clinical trial is set to open, with multiple sites in various countries.

The initial laboratory discovery and collaboration with Genentech and BioNTech led to this potential treatment. Research on immune protection in long-term pancreatic cancer survivors was published in Nature in November 2017. The mRNA vaccine technology was used to deliver neoantigens to patients as vaccines, with an individualized therapeutic mRNA cancer vaccine tailored to each patient's tumor. The clinical trial was completed in 18 months, ahead of schedule, with funding and support from Stand Up To Cancer, Lustgarten Foundation, Ben and Rose Cole Charitable PRIA Foundation, and Damon Runyon Cancer Research Foundation.

At an 18-month median follow-up, patients with vaccine-expanded T cells (responders) had longer median recurrence-free survival compared to non-responders (13.4 months, P = 0.003). Adjuvant atezolizumab, autogene cevumeran, and mFOLFIRINOX induced substantial T cell activity that may correlate with delayed PDAC recurrence.

In conclusion, this experimental personalized cancer vaccine offers a glimmer of hope for pancreatic cancer patients like Barbara Brigham. While the results are still preliminary, they show promise for a future where more people can overcome this deadly disease. As larger clinical trials are underway, the medical community eagerly awaits further developments in this groundbreaking research.