The results of a Phase 1 clinical trial launched by the Dana-Farber Cancer Institute for Melanoma patients show that an up-to-date type and delivery of the personalized Neovax cancer called NeovaxMI It is safe, feasible and improves the vaccine -specific immune response compared to previous platform tests.
Findings are published in Cell.
We believe that the immunogenicity of today’s personalized cancer vaccines, which is considered critical to their effectiveness, can be significantly improved. This study provides evidence that changes in formulation and administration improve the power of vaccines. ”
Patrick Ott, MD, PhD, Senior-Author, Clinical Manager of the Center for Melanoma Disease in Dana-Farber
OTT started the test that enrolls patients with previous melanoma that had not been treated or high -risk with the aim of fully vaccinating all patients with neovaxMI and perform in depth analysis of their immunomodials. No official clinical results were planned beyond the safety and feasibility of the vaccine for the test.
NeoavaxMI It is a personalized vaccine targeting Neovax-based Neovax platform originally developed on Dana-Farber by OTT and Catherine Wu, MD, head of the department of stem cell transplants and cell therapies, who is also a senior writer on paper. Neovax includes personalized neo-panties, which are protein fragments that occur in a patient’s cancer cells rather than normal cells, as well as an immunostimulant called Poly-ILC. NeoavaxMI It adds another immune enhancement compound called Montadine to the mixture.
Neovax administrationMI The test also changed to include two additional immunotherapy. Patients received a systematic nivolumab before, during and after the series of vaccines. Systematic Nivolumab reduces the suppression of the immune system and is a model of care for patients with resection or advanced melanoma. They also received ipilimumab locally at the vaccination position during the vaccines. The addition of subcutaneous administration of ipilimumab is projected to enhance the activation of immune cells called T cells to respond to the antigens imported from the vaccine.
Nine patients were completely vaccinated. To estimate the size of T cells caused by NeovaxMIThe group was isolated T cells from patient blood samples after vaccination and evaluated their ability to recognize and respond to specifically with neo -pondigen vaccines on a plate. They observed cells of cells in neo-pondigens and in nine patients and cytotoxic responses from specific T cells called CD-8+ T cells in six of nine patients.
“These observations of ex vivo CD-8+ T cells are what we want to see in a vaccine, and we were excited to see this important aspect of immuno-replication caused by the cancer in the current test, “Ott says.
The researchers also examined the biopsies of the skin obtained from the vaccine injection positions and ipilimumab using a cutting -edge sequence approaches. In these samples, they saw an increase in immune system cells called macrophages after vaccination, suggesting that NeovaxMI He put the area to start the immune activation in response to the vaccine.
“The right environment at the injection site to activate the cells of the immune system to start an immune waterfall is critical.” says Ott.
The group also showed that different sets of receptors expressed in T cells appeared after vaccination compared to standard treatment with nivolumab. The number of types of distinguished specific cells T cells activated after vaccination exceeded the number produced after treatment with nivolumab, indicating a strong vaccine -caused immune response.
Based on the volume samples of four patients and the use of new technologies that allow the definitive interrogation of individual (individual) T cells, the group confirmed that the invasive cells caused by a vaccine.
“These are exciting observations that show that this new wording and tradition strategy improves the power of vaccination,” says Ott. “The methods we used to measure immunoocialization are strict and unique in the field of regulating a clinical trial. With studies like this are important if we want to continue to improve personalized cancer vaccines.”
NeoavaxMI It was well tolerated and did not introduce new security concerns. The study is limited by its small size and by the introduction of three new factors together, which makes it difficult to accept observed improvements to specific changes in the vaccine.
Source:
Magazine report:
BLASS, E., et al. (2025). A Neoantigen Multi-Adjuvant vaccine produces strong melanoma immunity. Cell. Doi.org/10.1016/J.cell.2025.06.019.