Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’) is thrilled to announce the successful completion of naNO-COVID, a Phase I clinical trial in Switzerland evaluating the safety and reactogenicity of CoronaTcP™1 in healthy volunteers.
This multi-target T cell-priming set-point product is designed to effectively protect individuals from a myriad of Betacoronaviruses, such as SARS-CoV-1 and known and emerging variants of SARS-CoV-2, which could otherwise lead to devastating epidemics or pandemics.
With the successful completion of the trial, Emergex continues its mission to fight global infectious diseases and put up a formidable barrier against potential threats.
The clinical trial of CoronaTcP revealed that it has an impressive safety profile, with no serious treatment-related adverse events recorded. 88% of the adverse events reported were mild, mostly consisting of injection-site pain.
It is also noteworthy that the safety profile was not significantly affected whether participants received low or high doses. This gives confidence to the potential of the treatment to provide effective and safe relief.
The secondary immunogenicity analyses highlighted that most participants had already been exposed to SARS-CoV-2, while a few others had seroconverted during the trial despite mild symptoms, dictating that CoronaTcP does not exacerbate an acute phase of COVID-19.
Impressively, the cellular analyses illustrated that CoronaTcP (two doses administered at Day 0 and Day 21) was able to activate virus-specific CD8+ T cells, with a noticeable growth in the frequencies of CoronaTcP-specific CD8+ strong cells post antigenic stimulation for both the low and high dose groups at Day 35 post-treatment.
Remarkable changes in several specific virus-based CD8+ memory subpopulations were also noted. However, to truly evaluate the effects of T cell responses, including whether they are from a reinforcement or an initiation, and their association with immunity, more trials involving larger samples are imperative.
The innovative T cell-priming immune set-point candidates developed by Emergex have gained strong endorsement with the first-in-human clinical trials of naNO-DENGUE and naNO-COVID displaying a favorable safety profile with evidence of immunogenicity.
Such results demonstrate the potential of Emergex therapeutic platform and vindicate its approach to protection against RNA viruses, supporting the development of further products from the same platform for investigation. Overall, Phase I trial results provide proof that Emergex’s approach from its platform is effective and has the potential for wider application.
Emergex Co-Founder and CEO Thomas Rademacher is celebrating the milestone data from both naNO-DENGUE and naNO-COVID clinical trials, which shows that their innovative platform is safe and effectively eliciting broad, long-term immune memory.
This is the first time in clinical settings that a specific T cell response, solely based on T cell activity, has proven to be successful against infectious diseases. Rademacher is thrilled that this work is able to improve any previous immune status in patients.
The naNO-COVID Trial
The naNO-COVID trial (NCT05113862), conducted at the clinical investigation unit of the CHUV-UNIL in Switzerland, was a pioneering phase I study designed to assess the safety, immunogenicity, and reactogenicity of an anti-Betacoronavirus candidate – CoronaTcP – via two intradermal injections.
26 adults who were previously vaccinated against SARS-CoV-2 were randomly assigned to one of four groups – low- and high-dose CoronaTcP, and low- and high-dose base nanoparticle comparator.
Following the intradermal injections on Day 0 and Day 21, participants were followed up for 6 months to monitor the effects of the treatments. The results of this trial could potentially pave the way for new therapies against the Betacoronavirus.
Emergex’s T cell priming platform technology recently underwent a successful two-stage clinical trial, beginning with the highly promising safety data of the naNO-DENGUE trial before proceeding to the second stage: naNO-COVID. With promising results from the interim analysis, the second stage was quickly initiated in an effort to develop a successful platform for the fight against COVID-19.
About Emergex
Emergex, the groundbreaking biotechnology company headquartered in Abingdon, UK, with a subsidiary in Pennsylvania, USA, is pioneering the development of 100% synthetic and T cell-priming immune set-point therapeutic candidates to protect us from global health threats.
From Betacoronavirus to Universal Influenza A and even tularemia,Emergex aims to create treatments to fight infections and diseases that pose a serious, imminent risk to our health and wellbeing. With an eye on the future, they are actively exploring the potential for more applications.