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Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #20.17

AstraZeneca’s AZD1222 COVID-19 vaccine enters phase 2/3 clinical trial

In the previous report we have mentioned the positive interim phase 1 results from Moderna with its mRNA-1273 vaccine against SARS-COV-2.

In the current report we wish to report about AstraZenecas’ AZD1222 (also known as ChAdOx1 nCOV-19), a COVID-19 vaccine, partnered from the University of Oxford, which was administered to the two first patients on April 23. The Anglo-Sweedish company has announced that it has started a phase 2/3 clinical trial set to enrol 10,260 people in the UK, in order to generate sufficient data to support a regulatory approval and the delivery to subjects in September, despite the still unavailable phase 1 data.

The phase 2 will have more relaxed inclusion criteria, while enrolling children, aged 5 to 12 years old and adults aged 56 years and older, as well as one cohort of subjects aged over 70 years.

The phase 3 trial aims at enrolling subjects age 18 years and older and participants will be randomized to receive one or two doses of AZD1222 or a vaccine against meningococcal bacteria.  Enrollment is supposed to be completed in June.

AZD1222 is one of the nine COVID-19 vaccine under development that uses an adenovirus vector, which has been developed by the Jenner Institute and the Oxford Vaccine Group in the U.K. AZD 1222 is based on a recombinant chimpanzee adenovirus (ChAdOx1) and the genetic material coding for the COVID-19 spike protein.

We are aware of one other adenovirus-based vaccine currently undergoing clinical trial, namely Ad5-nCoV, jointly developed by Cansino Biologics (Tianjin, China) and the Beijing Institute of Biotechnology in China.

On May 20, Inovio (Plymouth Meeting, Pennsylvania, USA) released animal data showing INO-4800, a DNA-based vaccine, generated neutralizing antibodies against SARS-CoV-2 in animals. Inovio CEO Joseph Kim indicated “Our 40 volunteers should be getting their second dose by early next week, after the Memorial Day holiday” and he hopes to start a phase 2/3 efficacy trial in July. Analysts are nevertheless cautious about this statement mainly because Inovio has so far failed to get a DNA vaccine approved in the past.

The speed at which the new clinical vaccine candidates are being progressed are clearly unprecedented and are mainly due to previous work performed to tackle earlier coronavirus epidemics such as SARS in 2003 and MERS in 2012, work which could easily be applied to SARS-COV-2.

On May 21, AstraZeneca announced that it has received  a pledge of $1.2 billion from the US Biomedical Advanced Research and Development Authority (BARDA) to accelerate the development and the production of AZD1222  and secure 300 million doses for the United States. The deal allows AstraZeneca to launch a phase 3 clinical trial with around 30,000 subjects recruited in the US. “This contract with AstraZeneca is a major milestone in Operation Warp Speed’s work toward a safe, effective available vaccine by 2021” US Health Secretary Alex Azar said. AstraZeneca has ongoing agreements for 400 million doses and has secured manufacturing capacity for 1 billion doses. Earlier in the month AstraZeneca had announced an agreement to deliver 100 million doses to people in Britain, with 30 million available as soon as September. UK Ministers have promised Britain will get first access to the vaccine. These announcements have not provoked  the same uproar than the one triggered, last week, by Sanofi’s CEO Paul Hudson statement who had to publicly backpedal after a French outrage.

Paris, May 23, 2020

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