ExpreS2ion’s joint venture AdaptVac and AGC Biologics, a global Contract Development and Manufacturing Organization (CDMO) for Biopharmaceuticals, have entered into a partnership for the scale-up and cGMP manufacture of the COVID-19 vaccine, which is under development in the PREVENT-nCoV consortium. The partnership between AdaptVac and AGC Biologics has the potential to advance the initiation of the first clinical trial to the end of 2020, which may cut weeks or months from the originally announced time plan, primary reason being that it was not anticipated to being able to enter into a CDMO partnership on this side of the Summer. With the AGC Biologics collaboration it may be possible to produce the first clinical supply batch under certified good manufacturing practice (cGMP) during Q3 2020.
In the context of the PREVENT-nCoV consortium ExpreS2ion has now documented its ability to produce the SARS-CoV-S2 protein antigen in ExpreS2, a unique Drosophila S2 insect cell-based production system. Both the Spike (S) protein and the receptor binding domain (RBD) proteins are already made in sufficient purity and quality for animal testing. Vaccine formulation is currently on-going, and the consortium has already initiated initial in vivo experiments, which will allow selection of the final vaccine candidate. The outcome of these can be expected at the start of Q3 2020, which is a significant acceleration of the originally announced development plan.
With a cGMP compliant and commercial supply-experienced CDMO like AGC biologics engaged in the COVID-19 vaccine program, ExpreS2ion and AdaptVac accelerate their efforts to further support the project by applying for grants to support the vaccine development project and by actively searching for late-stage clinical and commercial partnerships, that can even accelerate the COVID-19 vaccine project further to provide a COVID-19 vaccine for patients and people around the World.
ExpreS2ion’s CEO Bent Frandsen comments:
“It is great for the COVID-19 vaccine program to have the leading CDMO biopharmaceutical company AGC Biologics to develop and produce the vaccine to be compliant with Good Manufacturing Practice (GMP) and support the clinical and commercial supply plans. I am very pleased that we are progressing the COVID-19 vaccine program ahead of schedule. The teams of ExpreS2ion and AdaptVac, as well as the other PREVENT-nCoV consortium participants work tirelessly towards bringing our unique SARS-CoV-2 vaccine into the clinical development stage.”
The COVID-19 Coronavirus outbreak
A novel Coronavirus (COVID-19) outbreak was reported in Wuhan, China in late December 2019 and declared a pandemic by WHO on March 11th, 2020. The COVID-19 Coronavirus is a part of the same family as SARS and MERS, and there have been more than 2.5 million confirmed cases and over 175 000 deaths reported as of April 23rd, 2020. The latest situation updates are available on the WHO web page: https://www.who.int/emergencies/diseases/novel-coronavirus-2019.
AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO) with a strong commitment to deliver the highest standard of service to clients and partners. The company currently employs more than 900 employees worldwide. AGC Biologics’ global network spans three continents, with cGMP-compliant facilities in Seattle, Washington; Copenhagen, Denmark; Heidelberg, Germany; and Chiba, Japan.
The PREVENT-nCoV consortium
On 6th March, 2020, ExpreS2ion announced an EU Horizon 2020 grant award for the COVID-19 vaccine development programme for a consortium, whose members are world-leading experts in their respective fields, covering all relevant areas of viral research and vaccine development required for rapid clinical development of a COVID-19 vaccine. This includes pre-clinical and clinically validated experience from working with similar Coronaviruses such as MERS and SARS, ExpreS2ion’s Drosophila S2 insect cell expression system, and AdaptVac’s capsid virus-like particle (cVLP) technology. In addition to ExpreS2ion and AdaptVac, the consortium members are Leiden University Medical Center (LUMC), Institute for Tropical Medicine (ITM) at University of Tübingen, The Department of Immunology and Microbiology (ISIM) at University of Copenhagen, and the Laboratory of Virology at Wageningen University.
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