Periodic Reporting for period 2 - CancERVacc (Targeting Cancer with ERV Vaccines)
Período documentado: 2023-07-01 hasta 2025-10-31
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.
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.
Key Activities:
* Completion of a comprehensive preclinical data package, demonstrating efficacy in multiple cancer models (pancreatic, ovarian, breast, prostate, and NSCLC).
* Full process development for the manufacture of IPT001, including scalable, GMP-compatible production of Ad19 and Ad5F35 vectors.
* Engagement with regulatory authorities (notably AEMPS in Spain) to secure scientific advice and validation of the project’s CMC, toxicology, and clinical strategies.
* Strategic hiring to strengthen the team, including a new CEO, CMO, and expansion of the scientific advisory board.
Main Achievements:
* In strong process of demonstrating that both Ad19 and Ad5F35 vectors can be manufactured at scale with high yield, stability, and purity.
* Received positive regulatory feedback validating the manufacturing and toxicology strategies, as well as the adequacy of the preclinical data for clinical trial application (CTA).
* Defined the target population for the FIH trial (NSCLC based on emerging data and stakeholder input).
* Filed new patents, expanded the IP portfolio, and rebranded the company to HERVolution Therapeutics to reflect the broader platform potential.
* Completion of a comprehensive preclinical data package, demonstrating efficacy in multiple cancer models (pancreatic, ovarian, breast, prostate, and NSCLC).
* Full process development for the manufacture of IPT001, including scalable, GMP-compatible production of Ad19 and Ad5F35 vectors.
* Engagement with regulatory authorities (notably AEMPS in Spain) to secure scientific advice and validation of the project’s CMC, toxicology, and clinical strategies.
* Strategic hiring to strengthen the team, including a new CEO, CMO, and expansion of the scientific advisory board.
Main Achievements:
* In strong process of demonstrating that both Ad19 and Ad5F35 vectors can be manufactured at scale with high yield, stability, and purity.
* Received positive regulatory feedback validating the manufacturing and toxicology strategies, as well as the adequacy of the preclinical data for clinical trial application (CTA).
* Defined the target population for the FIH trial (NSCLC based on emerging data and stakeholder input).
* Filed new patents, expanded the IP portfolio, and rebranded the company to HERVolution Therapeutics to reflect the broader platform potential.
Innovative Results:
* First company to make HERVs druggable as tumor-specific antigens, opening new therapeutic possibilities for dozens of cancer indications.
* The prime-boost vaccine approach (Ad19 + Ad5F35) is novel and has shown robust immunogenicity and manufacturability.
* The project’s platform can be extended to other senescence-related diseases, such as ALS, beyond oncology.
Potential Impacts and Needs for Further Uptake:
* The technology has the potential to change the paradigm in cancer immunotherapy, especially in combination with other immuno-oncology drugs.
* To ensure further uptake and success, continued research, demonstration in clinical trials, access to markets and finance, robust IPR management, and supportive regulatory frameworks are essential.
* The project has already established collaborations and is actively engaging with investors, clinicians, and industry partners.
* First company to make HERVs druggable as tumor-specific antigens, opening new therapeutic possibilities for dozens of cancer indications.
* The prime-boost vaccine approach (Ad19 + Ad5F35) is novel and has shown robust immunogenicity and manufacturability.
* The project’s platform can be extended to other senescence-related diseases, such as ALS, beyond oncology.
Potential Impacts and Needs for Further Uptake:
* The technology has the potential to change the paradigm in cancer immunotherapy, especially in combination with other immuno-oncology drugs.
* To ensure further uptake and success, continued research, demonstration in clinical trials, access to markets and finance, robust IPR management, and supportive regulatory frameworks are essential.
* The project has already established collaborations and is actively engaging with investors, clinicians, and industry partners.