The CancERVacc project was initiated to address a critical challenge in cancer therapy: the lack of effective immunotherapies capable of targeting tumor-specific antigens that have, until now, been considered “undruggable.” Human endogenous retroviruses (HERVs) are such antigens—present in multiple cancer types, highly tumor-specific, but previously inaccessible to therapeutic intervention. The project’s central motivation is to unlock the therapeutic potential of HERVs, thereby expanding the reach and efficacy of cancer immunotherapy.
Project Vision and Pathway to Impact:
The overarching objective is to enable the first-in-human (FIH) evaluation of IPT001, a prime-boost adenoviral HERV-K cancer vaccine. The project is structured around five core scientific and regulatory objectives (manufacturing, toxicology, regulatory approval, and clinical trial preparation) and three supporting objectives (market intelligence, management, and ethics compliance). The pathway to impact involves:
* Completing robust preclinical proof-of-concept data.
* Developing scalable, GMP-compatible manufacturing processes for the vaccine vectors.
* Securing regulatory validation and alignment.
* Preparing for clinical trial application and execution.
Motivation and Needs Addressed:
Cancer remains a leading cause of morbidity and mortality in the EU and globally. While immunotherapies have transformed outcomes for some patients, many cancers remain resistant or poorly responsive. By targeting HERVs, CancERVacc aims to provide a new class of immunotherapy with broad applicability, potentially benefiting patients with a wide range of solid tumors. The project also supports EU priorities in health innovation, industrial competitiveness, and patient access to advanced therapies.
Scale and Significance of Impact:
* First program to clinically validate HERV-targeted immunotherapy.
* Platform approach enables rapid expansion into additional cancer indications and combination therapies.
* Potential to change the paradigm in cancer immunotherapy and extend benefits to other diseases, such as ALS.
