Inovio Pharmaceuticals (NASDAQ:INO) jumps 20% premarket on robust volume on the heels of its accelerated timeline for INO-4800, its planned DNA vaccine for COVID-19.
Human studies will launch next month in the U.S.
(in 30 healthy volunteers) and “soon thereafter” in China and South
Korea. Data will be published in the fall and 1M doses should be
available by year-end for emergency use.
President & CEO Dr. J. Joseph Kim says the
company designed the vaccine in three hours after the publication of the
genetic sequence of SARS-CoV-2, the coronavirus causing the current
outbreak.
Omeros (NASDAQ:OMER) reports
an update on clinical data from its pivotal trial of narsoplimab, a
human monoclonal antibody targeting mannan-binding lectin-associated
serine protease 2 (MASP-2) in the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy (HSCT-TMA), markedly
exceeding the FDA-agreed threshold for the primary efficacy endpoint.
Primary Endpoint: 15% is the FDA-agreed efficacy
threshold for the primary endpoint (i.e., the complete response rate
(CRR) in the clinical trial).
The CRR for the study population, and the lower
limit of the 95% confidence interval (95% CI), significantly exceed the
efficacy threshold.
Secondary Endpoints: The 100-day survival is 68%
in all treated patients, 83% in patients who received at least 4 weeks
of narsoplimab treatment, and 93% in patients who responded to
narsoplimab treatment.
Recent FDA meeting highlights and CMC updates:
FDA confirmed that the number of HSCT-TMA patients
enrolled is sufficient for the BLA’s filing and review for approval.
FDA agreed to stopping enrollment.
The Agency requested near-term manufacturing dates for narsoplimab.
FDA and Omeros’ reached agreement on CMC requirements for stability data and release assays.
In addition to its HSCT-TMA program, Omeros is
enrolling its narsoplimab Phase 3 clinical trials for immunoglobulin A
nephropathy and atypical hemolytic uremic syndrome .
The FDA has designated Kura Oncology’s (NASDAQ:KURA)
lead drug tipifarnib for Fast Track review for the treatment of adults
with relapsed or refractory angioimmunoblastic T-cell lymphoma,
follicular T-cell lymphoma and nodal peripheral T-cell lymphoma with T
follicular helper phenotype.
Fast Track status provides for more frequent
interaction with the FDA review team and a rolling review of the
marketing application.
Tipifarnib is inhibits an enzyme called
farnesyltransferase which plays a key role in cell cycle progression.
Since cancer is defined as unregulated cell proliferation, inhibiting
the enzyme would theoretically inhibit cancer progression.
Heat Biologics (NASDAQ:HTBX) is the latest company to jump on the coronavirus bandwagon with its announcement
that subsidiary Zolovax has formally launched a program to develop a
vaccine for treating or preventing infection from SARS-CoV-2, the
coronavirus causing the current outbreak (COVID-19).
It has also filed a provisional patent application covering the use of its gp96 vaccine platform for the potential indication.
Chinese hospitals overflowing with COVID-19 patients a few weeks ago
now have empty beds. Trials of experimental drugs are having difficulty
enrolling enough eligible patients. And the number of new cases reported
each day has plummeted the past few weeks.
These are some of the startling observations in a report released on 28 February
from a mission organized by the World Health Organization (WHO) and the
Chinese government that allowed 13 foreigners to join 12 Chinese
scientists on a tour of five cities in China to study the state of the
COVID-19 epidemic and the effectiveness of the country’s response. The
findings surprised several of the visiting scientists. “I thought there
was no way those numbers could be real,” says epidemiologist Tim
Eckmanns of the Robert Koch Institute, who was part of the mission.
But the report is unequivocal. “China’s bold approach to contain the
rapid spread of this new respiratory pathogen has changed the course of a
rapidly escalating and deadly epidemic,” it says. “This decline in
COVID-19 cases across China is real.”
The question now is whether the world can take lessons from China’s
apparent success—and whether the massive lockdowns and electronic
surveillance measures imposed by an authoritarian government would work
in other countries. “When you spend 20, 30 years in this business it’s
like, ‘Seriously, you’re going to try and change that with those
tactics?’” says Bruce Aylward, a Canadian WHO epidemiologist who led the
international team and briefed journalists about its findings in
Beijing and Geneva last week. “Hundreds of thousands of people in China
did not get COVID-19 because of this aggressive response.”
“This report poses difficult questions for all countries currently
considering their response to COVID-19,” says Steven Riley, an
epidemiologist at Imperial College London. “The joint mission was highly
productive and gave a unique insight into China’s efforts to stem the
virus from spread within mainland China and globally,” adds Lawrence
Gostin, a global health law scholar at Georgetown University. But Gostin
warns against applying the model elsewhere. “I think there are very
good reasons for countries to hesitate using these kinds of extreme
measures.”
There’s also uncertainty about what the virus, dubbed SARS-CoV-2,
will do in China after the country inevitably lifts some of its
strictest control measures and restarts its economy. COVID-19 cases may
well increase again.
The report comes at a critical time in what many epidemiologists now
consider a pandemic. Just this past week, the number of affected
countries shot up from 29 to 61. Several countries have discovered that
they already have community spread of the virus—as opposed to cases only
in travelers from affected areas or people who were in direct contact
with them—and the numbers of reported cases are growing exponentially.
The opposite has happened in China. On 10 February, when the advance
team of the WHO-China Joint Mission began its work, China reported 2478
new cases. Two weeks later, when the foreign exerts packed their bags,
that number had dropped to 409 cases. (Yesterday, China reported only
206 new cases, and the rest of the world combined had almost nine times
that number.) The epidemic in China appears to have peaked in late
January, according to the report.
Ambitious, agile, and aggressive
The team began in Beijing and then split into two groups that, all
told, traveled to Shenzhen, Guangzhou, Chengdu, and the hardest hit
city, Wuhan. They visited hospitals, laboratories, companies, wet
markets selling live animals, train stations, and local government
offices. “Everywhere you went, anyone you spoke to, there was a sense of
responsibility and collective action, and there’s war footing to get
things done,” Aylward says.
The group also reviewed the massive data set that Chinese scientists
have compiled. (The country still accounts for more than 90% of the
global total of the 90,000 confirmed cases.) They learned that about 80%
of infected people had mild to moderate disease, 13.8% had severe
symptoms, and 6.1% had life-threatening episodes of respiratory failure,
septic shock, or organ failure. The case fatality rate was highest for
people over age 80 (21.9%), and people who had heart disease, diabetes,
or hypertension. Fever and dry cough were the most common symptoms.
Surprisingly, only 4.8% of infected people had runny noses. Children
made up a mere 2.4% of the cases, and almost none was severely ill. For
the mild and moderate cases, it took 2 weeks on average to recover.
A critical unknown is how many mild or asymptomatic cases occur. If
large numbers of infections are below the radar, that complicates
attempts to isolate infectious people and slow spread of the virus. But
on the positive side, if the virus causes few, if any, symptoms in many
infected people, the current estimated case fatality rate is too high.
(The report says that rate varies greatly, from 5.8% in Wuhan, whose
health system was overwhelmed, to 0.7% in other regions.)
To get at this question, the report notes that so-called fever
clinics in Guangdong province screened approximately 320,000 people for
COVID-19 and only found 0.14% of them to be positive. “That was really
interesting, because we were hoping and maybe expecting to see a large
burden of mild and asymptomatic cases,” says Caitlin Rivers, an
epidemiologist at the Johns Hopkins Center for Health Security. “That
piece of data suggests that’s not happening, which would imply that the
case fatality risk might be more or less as we currently have.” But
Guangdong province was not a heavily affected area, so it is not clear
whether the same holds in Hubei province, which was the hardest hit,
Rivers cautions.
Much of the report focuses on understanding how China achieved what
many public health experts thought was impossible: containing the spread
of a widely circulating respiratory virus. “China has rolled out
perhaps the most ambitious, agile, and aggressive disease containment
effort in history,” the report notes.
The most dramatic—and controversial—measure was the lockdown of Wuhan
and nearby cities in Hubei province, which has put at least 50 million
people under a mandatory quarantine since 23 January. That has
“effectively prevented further exportation of infected individuals to
the rest of the country,” the report concludes. In other regions of
mainland China, people voluntarily quarantined and were monitored by
appointed leaders in neighborhoods.
Chinese authorities also built two dedicated hospitals
in Wuhan in just over 1 week. Health care workers from all over China
were sent to the outbreak’s center. The government launched an
unprecedented effort to trace contacts of confirmed cases. In Wuhan
alone, more than 1800 teams of five or more people traced tens of
thousands of contacts.
Aggressive “social distancing” measures implemented in the entire
country included canceling sporting events and shuttering theaters.
Schools extended breaks that began in mid-January for the Lunar New
Year. Many businesses closed shop. Anyone who went outdoors had to wear a
mask.
Two widely used mobile phone apps, AliPay and WeChat—which in recent years have replaced cash in China—helped enforce the restrictions,
because they allow the government to keep track of people’s movements
and even stop people with confirmed infections from traveling. “Every
person has sort of a traffic light system,” says mission member Gabriel
Leung, dean of the Li Ka Shing Faculty of Medicine at the University of
Hong Kong. Color codes on mobile phones—in which green, yellow, or red
designate a person’s health status—let guards at train stations and
other checkpoints know who to let through.
“As a consequence of all of these measures, public life is very
reduced,” the report notes. But the measures worked. In the end,
infected people rarely spread the virus to anyone but members of their
own household, Leung says. Once all the people in an apartment or home
were exposed, the virus had nowhere else to go and chains of
transmission ended. “That’s how the epidemic truly came under control,”
Leung says. In sum, he says, there was a combination of “good old social
distancing and quarantining very effectively done because of that
on-the-ground machinery at the neighborhood level, facilitated by AI
[artificial intelligence] big data.”
Deep commitment to collective action
How feasible these kinds of stringent measures are in other countries
is debatable. “China is unique in that it has a political system that
can gain public compliance with extreme measures,” Gostin says. “But its
use of social control and intrusive surveillance are not a good model
for other countries.” The country also has an extraordinary ability to
do labor-intensive, large-scale projects quickly, says Jeremy Konyndyk, a
senior policy fellow at the Center for Global Development: “No one else
in the world really can do what China just did.”
Nor should they, says lawyer Alexandra Phelan, a China specialist at
Georgetown’s Center for Global Health Science and Security. “Whether it
works is not the only measure of whether something is a good public
health control measure,” Phelan says. “There are plenty of things that
would work to stop an outbreak that we would consider abhorrent in a
just and free society.”
The report does mention some areas where China needs to improve,
including the need “to more clearly communicate key data and
developments internationally.” But it is mum on the coercive nature of
its control measures and the toll they have exacted. “The one thing
that’s completely glossed over is the whole human rights dimension,”
says Devi Sridhar, an expert on global public health at the University
of Edinburgh. Instead, the report praises the “deep commitment of the
Chinese people to collective action in the face of this common threat.”
“To me, as somebody who has spent a lot of time in China, it comes
across as incredibly naïve—and if not naïve, then willfully blind to
some of the approaches being taken,” Phelan says. Singapore and Hong
Kong may be better examples to follow, Konyndyk says: “There has been a
similar degree of rigor and discipline but applied in a much less
draconian manner.”
The report doesn’t mention other downsides of China’s strategy, says
Jennifer Nuzzo, an epidemiologist at the Johns Hopkins University
Bloomberg School of Public Health, who wonders what impact it had on,
say, the treatment of cancer or HIV patients. “I think it’s important
when evaluating the impact of these approaches to consider secondary,
tertiary consequences,” Nuzzo says.
And even China’s massive efforts may still turn out to have only
temporarily slowed the epidemic. “There’s no question they suppressed
the outbreak,” says Mike Osterholm, head of the Center for Infectious
Disease Research and Policy at the University of Minnesota, Twin Cities.
“That’s like suppressing a forest fire, but not putting it out. It’ll
come roaring right back.” But that, too, may teach the world new
lessons, Riley says. “We now have the opportunity to see how China
manages a possible resurgence of COVID-19,” he says.
Aylward stresses that China’s successes so far should give other
countries confidence that they can get a jump on COVID-19. “We’re
getting new reports daily of new outbreaks in new areas, and people have
a sense of, ‘Oh, we can’t do anything,’ and people are arguing is it a
pandemic or not,” Aylward says. “Well, sorry. There are really practical
things you can do to be ready to be able to respond to this, and that’s
where the focus will need to be.” https://www.sciencemag.org/news/2020/03/china-s-aggressive-measures-have-slowed-coronavirus-they-may-not-work-other-countries
Yesterday, Amazon (NASDAQ:AMZN) warned customers that its Prime Now and Amazon Fresh delivery services would have limited availability and slower delivery times.
Amazon hasn’t reduced the workforce of either
service. The delays are tied to a surge in demand due to coronavirus
fears, according to Bloomberg sources.
A driver for Amazon Flex, which has drivers using
their own vehicles for deliveries, says there has been a surge in
bottled water purchases.
The European Central Bank is preparing possible measures to provide
liquidity to businesses hit by the economic fallout of the coronavirus
outbreak, three sources familiar with the discussion told Reuters.
With the virus spreading around the globe, central banks are coming
under pressure to support growth, which is already suffering as a result
of travel restrictions, weakening demand, supply chain disruptions and a
sharp market sell-off.
The most prominent measure under discussion is a targeted longer-term
refinancing operation (TLTRO) directed at small- and medium-sized
enterprises in the 19-country euro zone, who may be hit hardest by the
downturn.
The sources said no decision on the scheme is imminent as preparatory work would take time.
An ECB spokesman declined to comment. ECB President Christine Lagarde
said late on Monday the bank is ready to take “appropriate and
targeted” measures.
The previous round of such loans were given to banks at the ECB’s
minus 0.5% deposit rate, essentially granting them a rebate if they met
their benchmarks to loan the cash out.
The simplest way to target the cash in a new scheme would be if
benchmarks were set so the money was given to smaller firms, whose
access to credit is generally more restricted than their bigger peers’,
making them more vulnerable to any slowdown.
The sources said that while the ECB has done preparatory work for
such a scheme in the past, plans would need to be scrutinized and
discussed by the policy-setting Governing Council before they can be
implemented.
“The facility could have specific features, including a shorter
maturity (up to 12 months), a fixed rate equal to the ECB’s deposit rate
(if not lower), and a maximum allowance that would be a function of
each individual bank’s exposure to SME lending,” Pictet Wealth
Management Strategist Frederik Ducrozet said.
Larger firms could also benefit from the lending scheme, some of the
sources said, although they are normally better-funded and already enjoy
the benefit of the ECB’s corporate sector bond purchases.
A fourth source added that some Governing Council members still see
the coronavirus outbreak as short-term issue and largely outside the
scope of monetary policy. ECB policymakers have already said governments
should lead the response to the coronavirus outbreak via fiscal policy.
The fourth source said that even after Lagarde’s statement on Monday,
policymakers maintain that the ECB should not rush to act and its moves
should be measured, keeping pressure on governments.
