Emergex T Cell-Priming Vaccine Candidate for Betacoronaviruses selected by NIH/NIAID Project NextGen for Inclusion in Clinical Trials

NIAID will be conducting and sponsoring clinical trials to accelerate and to streamline the rapid development of next-generation COVID-19 vaccines

ABINGDON, United Kingdom, Oct. 02, 2024 (GLOBE NEWSWIRE) — Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of synthetic T cell-priming vaccine candidates, today announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (Bethesda, MD, USA), has selected Emergex for inclusion in its Project NextGen. Through Project NextGen, NIAID is conducting early phase clinical trials on select next-generation SARS-CoV-2 vaccine candidates covering a broad range of platforms, including T cell vaccines. The objective of Emergex’s T cell-based platform is to generate a protective cellular immune response, specifically the generation of tissue-resident memory CD8 +T cells and, in the case of SARS-CoV-2, can provide a rapid recall response locally in the respiratory tract leading to an abortive infection. Induction of variant agnostic and long-lasting cell-mediated protection will limit the need for frequent boosters. The Emergex vaccine, CoronaTcP, is designed to be broadly effective against Betacoronavirus infections, including SARS-CoV-1, as well as known and emerging variants of SARS-CoV-2.

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.”

Emergex’s CoronaTcP candidate has demonstrated in a completed Phase I clinical trial in Switzerland to have a favorable safety profile and to successfully induce epitope-specific CD8+ memory subsets, which are critical for long-lasting protection against Betacoronaviruses in the face of high mutation rates and continuous emergence of new variants of those viruses. The Company also employs a variety of microneedle devices to achieve transdermal administration of its vaccines, which are 100% synthetic, and to facilitate development of both systemic and tissue-resident CD8 T cell memory responses. In addition, this delivery approach can overcome logistical constraints of traditional vaccines which require cold-chain measures during shipping, manufacturing, and conventional administration by healthcare professionals, all of which elements can significantly restrict global accessibility.

Emergex looks forward to this important next step in the development of its novel T cell-priming Betacoronavirus candidate. 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 clinical trial materials and documentation required for an investigational new drug (IND) submission.

About Project NextGen

Project NextGen is a $5 billion initiative to accelerate and to streamline the rapid development of next generation vaccines, drugs and treatments through public-private collaborations. Led by NIAID and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response (ASPR), Project NextGen is a coordinated effort between the US Federal Government and private sector to advance the pipeline of innovative vaccines, drugs and therapeutics from labs into clinical trials, with the intent to transition to the private sector in later stage development and proceed to potential US Food and Drug Administration (FDA) authorization, approval, and then commercial availability.

About Emergex

Emergex is a clinical-stage, privately held biotechnology company, headquartered in Abingdon, Oxon, UK, with an operating subsidiary in Doylestown, Pennsylvania, a microneedle manufacturing facility in Fremont, CA, USA and GMP production vaccine facility in Milton Park, UK. The Company is pioneering the development of 100% synthetic T cell-priming vaccine candidates designed to mimic the body’s natural T cell immune response to destroy and clear pathogen-infected cells, in order to protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel microneedles via skin immunisation into the epidermal layer, intended to reduce the burden and logistics associated with conventional preventative measures. Emergex’s first indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronaviruses, Dengue Fever and Pandemic Influenza candidates, as well as [ii] intracellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative immunotherapy candidates with the potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases.

Find out more online at www.emergexvaccines.com.

Visit our LinkedIn page or Twitter (X) account for updates.

For further information, please contact: