Findings from a Phase I trial initiated by Dana-Farber Cancer Institute have demonstrated that the NeoVax personalised cancer vaccine’s updated formula and delivery, NeoVaxMI,is not only feasible and safe but also elicits an improved vaccine-specific immune response in melanoma patients.
The trial’s subject enrolment was commenced by the institute’s Melanoma Disease Center clinical director Patrick Ott focused on those with previously untreated advanced or high-risk melanoma.
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The vaccine is based on the NeoVax platform developed by Ott and the Division of Stem Cell Transplantation and Cellular Therapies’ chief Catherine Wu.
NeoVax includes personalised neoantigens and an immunostimulant known as poly-ICLC, alongside another immune-boosting compound, Montadine.
For the trial, the feasibility and safety of the vaccine were planned without formal clinical outcome evaluations.
In the trial, the administration of NeoVaxMI also incorporated two additional immunotherapies.
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By GlobalDataSubjects were given systemic nivolumab, which decreases immune suppression, and ipilimumab was administered locally at the vaccination site during the vaccination series.
All nine patients in the trial were fully vaccinated, and to test the magnitude of NeoVaxMI-induced T cell responses, the team isolated these cells from the blood samples of the individuals post-vaccination and examined their potential to detect and respond to vaccine-specific neoantigens.
They found that T cell responses to neoantigens took place in all nine subjects, with six exhibiting cytotoxic responses by CD-8+ T cells.
Additionally, skin biopsies from the vaccine and ipilimumab injection sites showed an increase in macrophages, indicating that the vaccine primed the area to begin the immune system activation.
The researchers also noted that the variety of vaccine-specific T cells activated post-vaccination surpassed those produced by the standard treatment, nivolumab.
Using new technologies, the team confirmed that T cells induced by the vaccine infiltrated tumours in four subjects.
Ott said: “This study provides evidence showing that changes in formulation and administration improve the power of the vaccines.”
