"Study data also suggest that VB-111 may induce an immuno-therapeutic effect. Of the 46 patients who received VB-111, 25 patients experienced a fever post-dosing of VB-111 at least once, while 21 patients did not. Feverish patients demonstrated increased overall survival of 16 months, compared to non-feverish patients, who had a median overall survival of 8.5 months (p=0.03). This correlation between clinical efficacy and fever suggests that VB-111 may induce an immune response in patients and supports a role of the immune system as part of VB-111’s mechanism of action. "
At a high level, the fever suggests the activation of the innate immune system (the body detects foreign microorganisms), which heats up the body as a first line of defense. This then recruits/activates the adaptive immune system, which is more specific (and more potent). Evidence of cytotoxic CD8 T-cells and apoptotic cancer cells suggest that the adaptive immune system was present at the tumor site.
These fever responses were seen in rGBM and prOC (and I would guess Thyroid as well) patient populations treated with VB-111. I don't think the determination is final but it has the FDA and the medical community very curious/excited about what's going on with VB-111.
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