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UPDATE 1-CureVac's COVID-19 vaccine triggers immune response in Phase I trial

Mon, 02nd Nov 2020 12:54

* CureVac says set to launch trial with 30,000 volunteers

* Says immune response triggered in Phase I trial

* Chooses highest dosage of 12 micrograms for Phase III

* Says CVnCoV vaccine generally well tolerated

* Considering various options regarding vaccine partnership
(Adds size of prospective Phase III trial, spokesman comment on
dosage, possible partner)

By Ludwig Burger

FRANKFURT, Nov 2 (Reuters) - CureVac's experimental
COVID-19 vaccine triggered an immune response in humans, the
German biotech firm said on Monday, putting it on track to start
mass testing this year as the race to end the pandemic heats up.

"We are very encouraged by the interim Phase I data," Chief
Executive Officer Franz-Werner Haas said in a statement.

The biotech firm is using the so-called messenger RNA (mRNA)
approach, the same as Moderna as well as BioNTech
and its partner Pfizer, although they started
mass testing on humans in late July.

CureVac said its potential vaccine, known as CVnCoV, was
generally well tolerated and trial results strongly supported
the company's plans to launch the final stage of testing
involving about 30,000 participants before the end of the year.

CureVac - backed by German biotech investor Dietmar Hopp,
the Gates Foundation and GlaxoSmithKline - said
volunteers developed a level of neutralising antibodies on a par
with people who had recovered from a serious case of COVID-19.

The pandemic, which has claimed more than 1.2 million lives
globally, has triggered a scramble to develop a vaccine with
about 45 experimental compounds being tested on humans.

Britain's AstraZeneca, working with the University
of Oxford, is also among the leading contenders with late-stage
trial results expected this year. Their candidate is based on
another virus, rather than mRNA, to deliver genetic instructions
into the body for an immunisation effect.

Anthony Fauci, the top U.S. infectious diseases expert, said
on Thursday that the first doses of a safe and effective
coronavirus vaccine will likely become available to some
high-risk Americans in late December or early January.

LOOKING FOR A PARTNER

CureVac's hopes of offering a vaccine at much lower doses
than its mRNA competitors may have been dented as it has picked
the highest concentration of five dosages - from 2 to 12
micrograms per shot - for its prospective Phase III trial.

BioNTech and Pfizer have said the 30 microgram shot they
opted for in their late-stage trial had previously been shown to
produce antibody levels above those registered in people who had
recovered from COVID-19.

Moderna, which like BioNTech expects to have the first
efficacy data from its mass trial this month, is testing a 100
microgram shot that has also been shown to trigger an antibody
response above that of recovered patients.

A CureVac spokesman said even at 12 micrograms its dosage
was still a relatively low.

CureVac has said it was looking into a potential partnership
with a major pharmaceutical company as it seeks to scale up
development, production and distribution. The spokesman said on
Monday that the firm was looking into various options.

The 20-year-old company, which went public on the Nasdaq
exchange in August, said its Phase I study has so far enrolled
more than 250 healthy individuals aged 18 to 60 years in Germany
and Belgium.

It said its inoculation appears to also generate T cells
against the coronavirus, another key indicator of an effective
immune system arsenal, but more analysis of this was ongoing.

CureVac said side effects occurred mostly after the second
injection of its two-dose regimen and included fatigue,
headache, chills, muscle pain and, to a lesser extent, fever.

These conditions "resolved rapidly, usually within 24 to 48
hours", it said.
(Reporting by Ludwig Burger; Editing by David Clarke)

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