Emergex Vaccines Holding Limited 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.
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