Emergex Vaccines' T cell-priming vaccine candidate, CoronaTcP, has been selected by the National Institute of Allergy and Infectious Diseases (NIAID), a unit of the National Institutes of Health (NIH), for inclusion in clinical trials under the Project NextGen initiative. This selection aims to accelerate the development of next-generation vaccines against SARS-CoV-2 and its variants.
NIAID's Project NextGen is a $5 billion initiative focused on advancing innovative vaccines, drugs, and therapeutics through public-private collaborations. The project seeks to transition promising candidates from labs into clinical trials, with the ultimate goal of FDA authorization, approval, and commercial availability.
CoronaTcP: Aims for Broad Betacoronavirus Protection
CoronaTcP is designed to provide broad protection against Betacoronaviruses, including the original SARS-CoV-1 virus and various strains of SARS-CoV-2. The vaccine works by generating a robust cellular immune response, specifically inducing tissue-resident memory CD8+ T cells. These cells can rapidly respond to infections in the respiratory tract, potentially leading to an abortive infection and limiting the need for frequent booster vaccinations.
Professor Thomas Rademacher, Co-Founder and Chief Executive Officer of Emergex, stated, "We are thrilled that our immunotherapy candidate for Betacoronaviruses, which has already demonstrated an excellent safety profile and shown to be capable of eliciting targeted CD8 T cell immune memory, has been selected as part of the Project NextGen initiative."
Phase I Trial Data and Microneedle Delivery
In a completed Phase I clinical trial in Switzerland, CoronaTcP demonstrated a favorable safety profile and successfully induced epitope-specific CD8+ memory subsets. These subsets are considered critical for providing long-lasting protection against Betacoronaviruses, especially given the high mutation rates and continuous emergence of new variants.
Emergex utilizes microneedle devices for transdermal administration of its 100% synthetic vaccines. This delivery method supports the development of both systemic and tissue-resident CD8 T cell memory responses and can overcome logistical constraints associated with traditional vaccines, such as the need for cold-chain storage and administration by healthcare professionals.
Trial Funding and Responsibilities
NIAID is projected to cover the full cost of the Phase I clinical trial, including operations and related analyses. Emergex will be responsible for providing the clinical trial materials and documentation required for an investigational new drug (IND) submission.
Project NextGen's Broader Goals
Project NextGen is a coordinated effort between the US Federal Government and the private sector, led by NIAID and the Biomedical Advanced Research and Development Authority (BARDA). It aims to advance a pipeline of innovative vaccines, drugs, and therapeutics from labs into clinical trials, with the intent to transition to the private sector for later-stage development and potential FDA approval.
