Periodic Reporting for period 3 - TIGER (Proof of Principle of the best-in-class therapeutic mRNA cancer vaccine)
Periodo di rendicontazione: 2023-02-01 al 2024-01-31
TIGER delivers proof of principle (PoP) in humans for a novel best-in-class mRNA cancer vaccine platform optimized for intravenous (IV) administration, with the aim to show major clinical efficacy.
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 stimulate dendritic cells to start strong T cell responses. The mRNAs will be formulated in a novel patented lipid nanoparticle format shielding the mRNA, and delivering it to immunoactive antigen presenting cells, vastly enhancing T-cell response.
Safety and best-in-class 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 are 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.
Additionally, the project encompasses all essential elements for preparing therapy validation in later stage clinical studies, while adressing patient needs, values and choices. Furthermore, upscaling mRNA vaccine GMP-production will enable these further clinical studies. Once validated, our platform will be easily translatable to a wide range of cancers using other tumour antigens, be they TAAs or neoantigens.
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 stimulate dendritic cells to start strong T cell responses. The mRNAs will be formulated in a novel patented lipid nanoparticle format shielding the mRNA, and delivering it to immunoactive antigen presenting cells, vastly enhancing T-cell response.
Safety and best-in-class 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 are 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.
Additionally, the project encompasses all essential elements for preparing therapy validation in later stage clinical studies, while adressing patient needs, values and choices. Furthermore, upscaling mRNA vaccine GMP-production will enable these further clinical studies. Once validated, our platform will be easily translatable to a wide range of cancers using other tumour antigens, be they TAAs or neoantigens.
- The clinical trial is ready to start. All medicine is ready, the study sites are selected and we have ethical and regulatory approvals in multiple countries.
- eTheRNA decided to stop clinical development of EI-201. In the meantime a new beneficiary has been identified that can bring in an alternative drug product in the project (CD40HVAC)
- eTheRNA decided to stop clinical development of EI-201. In the meantime a new beneficiary has been identified that can bring in an alternative drug product in the project (CD40HVAC)
the first ever therapy curing HPV+ cancer patients