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Novavax fast-tracks phase 1 testing of coronavirus vaccine

Study of vaccine candidate is set to begin in mid-May

Clinical development

Novavax has announced that its primary coronavirus vaccine candidate – NVX-CoV2373 – is set to enter phase 1 clinical testing by mid-May.

The study will enrol around 130 healthy adults, and will assess dosage amount as well as the number of vaccinations needed for efficacy. According to the company, a single dose with NVX-CoV2373 demonstrated efficacy against the novel coronavirus, known as SARS-CoV-2, in pre-clinical testing.

Novavax has fast-tracked the development of the vaccine candidate with the aid of $4m in funding from the Coalition for Epidemic Preparedness Innovation (CEPI). According to the company’s head of R&D, Gregory Glenn, along with "excellent early results” this has “put us in position to have preliminary human data in July”.

CEPI is overseeing a number of efforts to develop a successful coronavirus vaccine and has provided funding for a range of programmes. This includes donations to Moderna, which has already dosed the first patients with its vaccine candidate, as well as Curevac, Inovio Pharmaceuticals and the University of Oxford.

In March, Novavax entered into an agreement with Emergent BioSolutions to provide contract development and manufacturing services. This covers the supplies for the manufacturing of Novavax’s vaccine product for use in clinical trials and also includes an option to allocate capacity for a scaled-up COVID-19 vaccine programme.

Although vaccine developers are accelerating research into the most promising candidates, the UK’s chief scientific adviser has previously said that a successful vaccine is 12-18 months away from being developed and distributed on a wider-scale for the general public.

In the meantime, a large number of companies are attempting to identify existing therapies which could have efficacy in treating the novel coronavirus disease, COVID-19.

That includes Japanese company Fujifilm Holdings Corp, which is hoping to repurpose its anti-flu drug Avigan (favipiravir) for the treatment of COVID-19 patients.

The company announced today that it will start phase 2 trials of the drug in patients in the US, after announcing last month that it had initiated phase 3 clinical testing of Avigan in COVID-19 patients in Japan.

The US trial will enrol around 50 COVID-19 patients to evaluate the efficacy of the anti-flu drug against the disease, in collaboration with Brigham and Women’s Hospital, Massachusetts General Hospital and the University of Massachusetts' Medical School.

According to Zhang Xinmin, an official at China’s Science and Technology Ministry, Fujifilm's drug has demonstrated promising results in clinical trials in Wuhan and Shenzhen involving 340 patients.

Patients treated with the drug in Shenzhen tested negative for the virus after a median of four days after becoming positive, compared with a median of 11 days for those not treated with the drug, according to public broadcaster NHK.

However, a Japanese health ministry source suggested that the drug was less effective in severely-ill COVID-9 patients.

‘We’ve given Avigan to 70-80 people, but it doesn’t seem to work that well when the virus has already multiplied,’ the source told the Japanese newspaper Mainichi Shimbun.

Article by
PMGroup

9th April 2020

From: Research

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