NEW YORK – Belgium-based biotech eTheRNA Immunotherapies said on Monday that it has received a €6.9 million ($8.2 million) grant from the EU commission to develop an mRNA-based vaccine for human papillomavirus 16 (HPV16)-positive cancers.
The EU's Technology Informatics Guiding Education Reform (TIGER), an initiative within the Horizon 2020 research and innovation program, awarded the grant to a consortium of academic, industry, and patient advocacy collaborators led by eTheRNA. Members of the consortium include the imaging contract research organization Radiomics, Amsterdam University Medical Center, and the European Cancer Patient Coalition, among others.
The consortium will use the funds to initiate a Phase I/II clinical trial of the mRNA vaccine, either alone or with an anti-PD-1 immunotherapy, for patients with metastatic or recurrent HPV16-positive cancers, including head and neck squamous cell carcinoma, cervical cancer, and anogenital cancer. The trial will evaluate the safety, immunogenicity, and clinical activity of the intravenously administered mRNA vaccine as key endpoints. Secondary endpoints will include patient-reported outcomes.
The treatment consists of antigens comprising mRNAs encoding the HPV16 proteins E6 and E7 in addition to eTheRNA's TriMix, a proprietary immune stimulator that is designed to activate dendritic cells and elicit strong T-cell responses to the antigens. According to eTheRNA, the treatment's safety has been demonstrated in preclinical studies, as well as in other clinical trials when administered in ways other than intravenously.
According to a statement from Marina Cools, eTheRNA's VP of clinical development, the collaboration will also explore the mRNA technologies in tumor types beyond HPV16-positive cancers.