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Proof of Principle of the best-in-class therapeutic mRNA cancer vaccine

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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Keywords

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Programme(s)

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Topic(s)

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Funding Scheme

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RIA - Research and Innovation action

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) H2020-SC1-BHC-2018-2020

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Coordinator

ETHERNA IMMUNOTHERAPIES
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 5 094 401,25
Address
GALILEILAAN 19
2845 Niel
Belgium

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Vlaams Gewest Prov. Antwerpen Arr. Antwerpen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 17 515 447,00

Participants (7)

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