CR2O is happy to announce that the First-in-Human trial with Dyadic’s SARS-CoV-2-RBD vaccine candidate DYAI-100 has started in South Africa.
Dyadic International Inc. is a global biotechnology company focused on further improving, applying and deploying its proprietary C1-cell protein production platform to accelerate development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales. Dyadic has entered into a master services agreement with CR2O, as full-service global contract research organization specializing in vaccinology, to manage preclinical and clinical development of Dyadic’s SARS-CoV-2–RBD vaccine candidate DYAI-100.
In July 2022, CR2O (on behalf of Dyadic) submitted a Clinical Trial Application (CTA) to the South African Health Products Regulatory Authority (SAHPRA) and the Witwatersrand Human Research Ethics Committee (WHREC) in order to gain approval to initiate a Phase I study with DYAI-100, a C1-SARS-CoV-2 recombinant protein RBD vaccine and clearance to start the trial was provided in October 2022.
The Phase I randomized, double blind, placebo-controlled trial is designed to demonstrate clinical safety and preliminary efficacy of DYAI-100.
Following the regulatory approval from the South African Health Products Regulatory Authority (SAHPRA) and the Witwatersrand Human Research Ethics Committee (WHREC), site preparations and recruitment was commenced and the first dosing for subjects began during the week of January 9th, 2023.
The Chief Scientific Officer of CR2O, Prof. Albert Osterhaus, applauds the collaborative efforts of Dyadic and CR2O. These have led to the approval and execution of this first in human Phase I trial with a candidate COVID-19 booster vaccine, produced with the novel C1-cell protein production platform. The use of this platform may well pave the way for faster, cheaper and easier production of vaccines and other biologicals to combat emerging viruses.
For Dyadic’s original press release, please refer to GlobeNewswire.
Curious to learn more about CR2O’s full-service global CRO activities, or experience with vaccine trials?
Please, contact Ellemieke von Mauw:
Ellemieke von Mauw
Director Clinical Programs | Business Development
T +31 (0)85 071 74 65 | M +31 (0)6 57 76 61 45 | E Ellemieke.firstname.lastname@example.org