Project description
New vaccine for HPV16-positive cancer tested
The EU-funded TIGER project will demonstrate the benefits of a novel mRNA cancer vaccine platform optimised for intravenous administration into patients. The antigens that will be used to deliver proof of principle comprise mRNAs encoding the proteins E6 and E7 of the human papillomavirus strain 16 (HPV16) and TriMix mRNAs that act as an adjuvant to stimulate dendritic cells to initiate strong T-cell responses. The study will be in patients with recurrent HPV16-positive cancer without and with a PD-1 checkpoint inhibitor. Safety, immunogenicity and clinical benefit will be key endpoints for this study. Once validated, the platform will be readily translatable to a wide range of cancers using other tumour antigens.
Objective
TIGER delivers proof of principle (PoP) in humans for a novel best-in-class therapeutic mRNA cancer vaccine platform optimized for intravenous (IV) administration, with the aim to show clinical benefit.
The antigens used for the PoP consists of mRNAs encoding the proteins E6 and E7 of Human Papilloma Virus strain 16 (HPV16), and TriMix mRNAs that act as adjuvant to stimulate dendritic cells to start strong T cell responses. The mRNAs will be formulated in a novel patented lipid nanoparticle shielding the mRNA, and delivering it to immunoactive antigen presenting cells, vastly enhancing T-cell response.
Safety and potent efficacy of our IV mRNA product have been demonstrated in rodent experiments. Furthermore, preclinical to clinical translation has been shown for our TriMix based vaccines using different delivery strategies. Based on the preclinical and prior clinical data, our platform has the potential to cure cancer patients.
The PoP study will be in patients with recurrent HPV16 positive cancer, which is categorised as a non-communicable disease by the WHO, without and with a PD-1 checkpoint inhibitor. Safety, immunogenicity and clinical benefit will be key endpoints of the study. Biomarker and PROM research will allow future informed therapeutic and care decisions by both patient and care team. Recruitment and stratification plans will be in place. Interactions with regulatory, reimbursement and ethical authorities together with patients and carers will help laying out the route to the patient not only for our product but also for all other mRNA cancer vaccines.
The project encompasses essential elements for preparing therapy validation in later stage clinical studies, while addressing patient needs, values and choices. Upscaling of GMP-production for IV mRNA vaccines will enable further clinical studies. Once validated, our platform will be easily translatable to a wide range of cancers using other tumour antigens, be they TSA, TAA or neoantigens.
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Funding Scheme
RIA - Research and Innovation actionCoordinator
2845 Niel
Belgium
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.