SilvacxBooster is a highly potent immunostimulant. The combination of pathogen-associated molecular patterns (PAMPs), which are loaded onto specially surface-modified silica nanoparticles, results in viral mimicry. The particles have the size and shape of small viral particles. By coating the surface with a TLR agonist, a virus is mimicked almost perfectly: highly immunogenic, but not pathogenic. After subcutaneous administration a potent immunostimulatory signal is sensed by innate pattern-recognition receptors and induces a type I interferon-dominated cytokine response. This leads to activation and maturation of dendritic cells and macrophages, strong activation of NK cells, and – at a lower magnitude – priming of T-cell responses, thereby amplifying both innate and adaptive antiviral immunity.
NK cells are a central component of anti-tumor immunity because they rapidly eliminate stressed or transformed cells without prior sensitization and remain particularly effective against tumors with diminished MHC class I expression. However, their cytotoxic function can be transiently impaired after surgical intervention, contributing to a temporary postoperative window of reduced immune surveillance. The postoperative period is a critical vulnerability window in cancer surgery because surgical stress transiently suppresses NK cell cytotoxicity and other anti-tumor immune functions. As a result, residual malignant cells and micrometastases may escape immune surveillance more easily and gain a foothold during early recovery. We developed the SilvacxBooster precisely to prevent this from happening.
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- any surgical procedure weakens the immune system heavily [Reference]?
In particular, the activity of NK cells is severely restricted for around two months [Reference]. Cytotoxic T cells are also weakened [Reference]. The more invasive the procedure is, the more the immune system is damaged [Reference]. - a weakened immune system is extremely detrimental to the prognosis in cases of cancer?
It’s a dilemma: for the most common types of cancer, there is no chance of a cure without removing the primary tumour. The tumor must be removed. However, this leads to a weakening of the immune system, which – now that the immunosuppressive primary tumor has been removed – could otherwise tackle tumor residues, dormant micrometastases and circulating tumor cells. Yet it is simply no longer capable of doing so. Consequently, unfortunately, recurrences [Reference] and metastases [Reference] all too often occur following cancer surgery. - the effect of surgical procedures on the immune system – and the significant adverse side effects associated with them – have been known for over 50 years [Reference]?
Yes, and unfortunately, the whole thing has simply been accepted as it is so far. - there is no immunostimulant authorised for use in humans that could meet this significant medical need?
Yes, and that is precisely why we developed together with OHRI the SilvacxBooster. The aim is to strengthen the innate immune system of cancer patients to such an extent that recurrences and metastases occur significantly less frequently following surgery. - around 10 million people undergo cancer surgery every year?
The market for this medicine is absolutely huge. However, to ensure that all patients have access to SilvacxBooster in the future – without causing health insurance schemes to collapse – the costs must be scalable downwards. This is guaranteed by our cost-effective, purely chemical manufacturing process. - administering a checkpoint inhibitor and SilvacxBooster could be the perfect combination?
Checkpoint inhibitors "release the brakes" [Reference] - SilvacxBooster repairs and tunes the motor! - SilvacxBooster is is on the verge of entering clinical trials in humans?
The most important preclinical toxicology studies have been completed. Efficacy in the transgenic mouse model was demonstrated using two different tumor models. SilvacxBooster was able to more than compensate for the effects of postoperative immunosuppression. In other words, the animals subjected to surgical stress developed fewer metastases than those not subjected to surgical stress. - we're looking for investors so we can test SilvacxBooster in a Phase I human trial?
We need approximately 4.5 million euros to have the SilvacxBooster manufactured to GMP standards and to be able to carry out the Phase I trial. We have a GMP roadmap, production quotations and a detailed trial protocol with a cost estimate for the Phase I trial.