Moderna moves three vaccines into final stage trials as it works to rebound from Covid slump

Moderna
has
more
to
offer
beyond
its

Covid
vaccine.

The
biotech
company
Wednesday
announced

positive
clinical
trial
data
on
three
experimental
vaccines
against

other
viruses.
The
company
is
moving
those
shots
to
final
stage
studies,
it
said.

The
update
brings
Moderna
a
step
closer
to
having

multiple
products
on
the
market,
which
it
badly
needs
amid

plunging
demand
for
Covid
shots
worldwide.
The
company’s
Covid
jab
is
its
only
commercially
available
product.

Moderna’s
stock
has
long
been
tied
to
that
vaccine,
with

shares
falling
nearly
45%
last
year. But
shares
of
the
company
closed
3%
higher
on
Wednesday
after
the
announcements.

Moderna
will
chart
its
post-Covid
future
Wednesday
during
its
fifth
annual
“Vaccines
Day,”
an
investor
event
in
Boston
focused
on
the
company’s
vaccine
portfolio.

That
business
has
an
estimated
total
addressable
market
of
$52
billion
for
infectious
disease
shots,
which
includes
$27
billion
for
respiratory
vaccines
and
more
than
$25
billion
for
latent
shots
and
other
jabs.

A
category
of
viruses
called
latent
viruses
linger
inside
patients
for
prolonged
periods
without
causing
any
symptoms
but
can “reactivate”
and
cause
serious
health
complications
later
in
their
lives.
They
represent
a
huge
unmet
need
that
Moderna
can
address,
Moderna
CEO
Stéphane
Bancel
told
CNBC
in
an
interview
on
Wednesday.

“Once
those
viruses
are
in
your
body,
it’s
in
your
body
forever,”
he
said,
adding
that
there
are
no
approved
shots
for
several
of
the
latent
viruses,
including
some
that
Moderna
is
targeting.

The
company
will
present
new
clinical
trial
data
on
the
three
vaccines,
including
some
against
latent
viruses,
at
the
event
Wednesday.

Those
vaccines
include
a
shot
against

norovirus,
a
highly
contagious
stomach
bug
that
causes
vomiting
and
diarrhea;
a
vaccine
against

Epstein-Barr
virus,
a
common
herpes
virus
that
can
cause
contagious
infections
and
is
associated
with
some
cancers;
and
a
shot
designed
to
target
a

virus
that
causes
shingles
and
chickenpox.

Moderna
will
also
discuss
other
updates
across
its
vaccine
business.
The
company
has
five
other
shots
in
late-stage
clinical
trials
and
said
it
expects
to
release
data
on
two
of
those
jabs
this
year.
That
includes
its
combination
vaccine
against
Covid
and
the
flu
and
a
shot
against
another
common
herpes
virus
called
cytomegalovirus,
or

CMV. 

Among
the
other
vaccines
in
late-stage
development
is
a
jab
against
respiratory
syncytial
virus,
or
RSV,
which
is
expected
to
win
regulatory
approval
in
the
U.S.
in
May. 

It
also
includes
a
new
and
improved
version
of
Moderna’s
Covid
shot.
The
company
on
Tuesday
said
its “next-generation”
Covid
shot
triggered
a

stronger
immune
response
against
the
virus
than
its
current
vaccine
on
the
market
in
a
late-stage
clinical
trial.

Another
shot
in
phase
three
trials
is
the
company’s
flu
vaccine.

Also
on
Wednesday,
Moderna
said
it
recently
entered
into
a
development
and
commercialization
funding
agreement
with

Blackstone
Life
Sciences,
a
private
equity
segment
of
The
Blackstone
Group.
Blackstone
will
fund
up
to
$750
million
to
advance
Moderna’s
flu
shot
program,
with “a
return
based
on
commercial
milestones”
and
low
single-digit
royalties. 

Bancel
told
CNBC
the
company’s
messenger
RNA
platform,
used
in
its
Covid
vaccine, “is
working
so
well”
against
other
diseases.
That
mRNA
technology
works
by
teaching
the
body
to
produce
a
harmless
piece
of
a
virus,
which
triggers
an
immune
response
against
certain
diseases.

“Think
about
the
[total
addressable
market]
Moderna
is
going
after
–
we’re
going
to
be
one
of
the
most
important
vaccine
companies
in
the
world,”
he
said.

Still,
it
will
take
time
before
Moderna’s
pipeline
will
pay
off.

The
company
in
its
third-quarter
earnings

release
in
November
said
it
expects
revenue
to
fall
to
$4
billion
in
2024
before
it
grows
again
in
2025.
It
expects
to
break
even
in
2026,
executives
said
during
a
November
earnings
call.

Moderna’s
latest
shots
to
move
into
late-stage
trials
represent
significant
opportunities
for
the
company.

There
is
currently
no
approved
shot
to
prevent
norovirus,
the
most
common
cause
of
the
stomach
flu.
The
virus
results
in
approximately
200,000
deaths
per
year
and
substantial
health-care
costs,
according
to
Moderna. 

The
company
examined
two
different
norovirus
shot
candidates
in
a
phase
one
trial
on
more
than
600
patients
ages
18
to
49
and
60
to
80
in
the
U.S.

An
interim
analysis
showed
that
a
single
dose
of
a
trivalent
vaccine
called
mRNA-1403
targeting
three
norovirus
strains
triggered
a
strong
immune
response
across
all
dose
sizes.
The
shot
also
had
a “clinically
acceptable”
safety
profile. 

Moderna
said
it
is
moving
that
shot
to
a
phase
three
trial. The
market
for
norovirus
vaccines
represents
a
$3
billion
to
$6
billion
annual
market,
according
to
the
company. 

There
are
also
no
shots
currently
approved
to
prevent
Epstein-Barr
virus.
It
accounts
for
more
than
90%
of
cases
of

infectious
mononucleosis,
a
contagious
infection
known
as
mono,
which
can
cause
fever,
sore
throat
and
chronic
fatigue.

Both
the
virus
and
mono
are
associated
with
a
higher
risk
of
certain
cancers.
The
virus
also
increases
a
patient’s
risk
of
developing
multiple
sclerosis
by
32-fold,
according
to
Moderna.
That
disease
is
characterized
by
the
the
immune
system
eating
away
at
the
protective
covering
of
nerves.

“It’s
a
big
issue
for
teenagers.
There
are
sometimes
kids
who
have
to
redo
a
year
of
high
school
or
college,
which
is
a
big
waste
of
your
life,”
Bancel
said. “But
it
has
also
been
associated
with
multiple
sclerosis,
which
is
a
terrible
disease
affecting
mostly
women
…
so
we
think
we
could
prevent
that.”

Moderna
has
been
developing
two
shots
designed
to
tackle
multiple
conditions
associated
with
Epstein-Barr
virus.
That
includes
a
shot
designed
to
prevent
mono
called
mRNA-1189,
which
will
move
to
a
phase
three
study
after
positive
early
stage
trial
data.

A
phase
one
trial
examined
that
vaccine
in
patients
12
to
30
years
old
in
the
U.S.
The
study
found
that
the
shot
produced
an
immune
response
against
mono
and
was
overall
well
tolerated
across
all
dose
sizes.

Moderna
is
developing
another
shot
called
mRNA-1195,
which
is
designed
to
target
multiple
sclerosis
and
a
subcategory
of
lymphoma
in
solid
organ
transplant
patients.
A
phase
one
trial
on
that
vaccine
is
fully
enrolled,
according
to
the
company.

Bancel
said
the
company
believes
the
Epstein-Barr
virus
will
be “a
several
billion
dollar
market.”

Varicella-Zoster
virus
causes
both
chickenpox
and
shingles.
Older
adults
have
declining
immunity
against
that
virus,
making
them
more
vulnerable
to
developing
painful,
itchy
and
blister-like
rashes.
About
1
in
3
adults
in
the
U.S.
will

develop
shingles
at
some
point
in
their
lives,
according
to
the
Centers
for
Disease
Control
and
Prevention. 

Moderna
studied
its
vaccine
against
the
virus,
mRNA-1468,
in
an
early
to
mid-stage
trial
on
healthy
adults
ages
50
and
older
in
the
U.S.

The
shot
caused
a
strong
immune
response
at
one
month
after
the
second
dose
and
was
generally
well
tolerated
by
patients,
according
to
the
company.
Additional
data
from
that
ongoing
trial
will
be
available
later
this
year.

Moderna
estimates
that
the
market
for
Varicella-Zoster
virus
could
be
$5
billion
to
$6
billion
annually.