NIH Selects T Cell-Priming Vaccine Candidate to be Included in Clinical Trials Under Project NextGen
Emergex’s T cell-priming candidate will be studied in early-phase trials in search for next generation of COVID-19 vaccines.
Emergex Vaccines has announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has selected its T cell-priming vaccine candidate against Betacoronaviruses for inclusion in Project NextGen. Emergex’s vaccine candidate will be evaluated alongside other potential candidates in early-phase trials to find the next generation of COVID-19 vaccines.1
In a press release, Professor Thomas Rademacher, co-founder and chief executive officer, Emergex said, “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. Our T cell-based platform technology has the potential to address current and future coronavirus challenges and thereby strengthen preparedness for future pandemics, through harnessing the natural course of cellular immunity by ensuring rapid, targeted and robust immune responses against emerging infectious threats.”
In July 2023, Emergex shared promising data from a completed Phase I trial of CoronaTcP, its multi-target T cell-priming set-point product designed to be effective against Betacoronaviruses, including SARS-CoV-1 and emerging variants of SARS-CoV-2.2
Results showed CoronaTcP demonstrated a favorable safety profile and the ability to induce epitope-specific CD8+ memory subsets, which are critical for long-lasting protection against Betacoronaviruses.
The Phase I trial, naNO-COVID (NCT05113862), was a double-blind, randomized, base particle-controlled, single center study evaluating the safety and reactogenicity of two intradermal injections of CoronaTcP at two different dosages. Based in Switzerland, the trial enrolled 26 adult participants previously vaccinated against SARS-CoV-2.
In an earlier press release, Rademacher said, “The positive data from both clinical trials—naNO-DENGUE and naNO-COVID—represent an important landmark for Emergex. Demonstrating that our platform has an acceptable safety profile and successfully mobilizes specific T cells that may elicit broad and long-term immune memory, validates our approach. By improving T cell-based immunity, we can enhance any previous immune status. We are delighted that this first assessment of a treatment against infectious diseases for clinical use, based solely on a T cell response, was successful.”
Project NextGen is well underway. In June, the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS) announced up to $500 million in Project NextGen funding to evaluate novel vaccines against COVID-19.3
“At ASPR, we are working to unlock technology that will better protect Americans from viruses like COVID-19,” Dawn O'Connell, assistant secretary for preparedness and response, HHS, said in a press release. “The next generation vaccines that BARDA is investing in may bolster our protection against COVID-19 and be easier to administer through intranasal or oral delivery.”
References
1. Emergex T Cell-Priming Vaccine Candidate for Betacoronaviruses selected by NIH/NIAID Project NextGen for Inclusion in Clinical Trials. News release. Emergex. October 2, 2024. Accessed October 7, 2024. https://emergexvaccines.com/emergex-t-cell-priming-vaccine-candidate-for-betacoronaviruses-selected-by-nih-niaid-project-nextgen-for-inclusion-in-clinical-trials/
2. Emergex Reports Promising Data from Completed Swiss Phase I Trial of CoronaTcP™, T Cell-Priming Immune Set-Point Candidate for Betacoronaviruses. News release. Emergex. July 19, 2023. Accessed October 7, 2024. https://emergexvaccines.com/emergex-reports-promising-data-from-completed-swiss-phase-i-trial-of-coronatcp-t-cell-priming-immune-set-point-candidate-for-betacoronaviruses/
3. BARDA awards up to $500 million in Project NextGen funding for vaccine clinical trials. News release. US Department of Health and Human Services. June 13, 2024. Accessed October 7, 2024. https://www.hhs.gov/about/news/2024/06/13/barda-awards-500-million-project-nextgen-funding-vaccine-clinical-trials.html
Newsletter
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Managing Side Effects and Dosing in Off-Label GLP-1 Use with Help from Real-World Evidence
July 18th 2025Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world data is helping researchers navigate gastrointestinal side effects, dose flexibility, and long-term tolerability in off-label GLP-1 use.
Anselamimab Misses Primary Endpoint in Phase III CARES Trials for AL Amyloidosis
July 17th 2025In the Phase III CARES trials, anselamimab did not meet the primary endpoint for advanced-stage AL amyloidosis, but a prespecified subgroup analysis revealed meaningful improvements in survival and cardiovascular outcomes.
