Coronavirus tracker: J&J’s stepped-up vaccine work, WuXi’s restart, Gilead’s knockoff and more

Eric Sagonowsky, Kyle Blankenship, Angus Liu | FierceBiotech

February 12, 2020

The novel coronavirus outbreak continues to send shockwaves around the world, but the virus only now has a name: SARS-CoV-2. The sickness caused by the virus has been named COVID-19. Meanwhile, confirmed cases have grown to more than 45,000, with fatalities rising past 1,100.

Some companies in China, such as Wuxi Biologics, are returning to work, but still monitoring the situation closely. Meanwhile, Johnson & Johnson is teaming up with the U.S. government on its vaccine work, while the NIH is lamenting its lack of a manufacturer for its Moderna-partnered shot. And a Chinese drugmaker says it has successfully knocked off—and scaled up production—of a Gilead Sciences antiviral under testing as a treatment.

We’ll be tracking the latest here.

UPDATED: Wednesday, Feb. 12 at 11:42 a.m. ET

After setting up a “skunkworks” for its attack on the novel coronovirus, Johnson & Johnson is teaming with the U.S. Biomedical Advanced Research and Development Authority to develop a vaccine. J&J is pooling money and resources with BARDA in an attempt to accelerate its vaccine candidate into phase 1 development. The company’s also gearing up manufacturing facilities for potential production.

By contrast, NIH and Moderna Therapeutics quickly kicked off their R&D program, but they don’t have a manufacturer yet. Neither partner has the capacity to produce the shot if it’s successful in clinical testing, an official said. But pharma companies might not want to sign up because they’d have to stop producing their own profit-making vaccines. Story

After Gilead’s remdesivir emerged as a promising treatment for the virus, a Chinese company has successfully copied the medicine and mass-produced active ingredients, it said in a filing. The company stressed that final marketing will require permission from Gilead. Story

WuXi Biologics is getting back to work. The company resumed operations at its sites in Wuxi, Shanghai and Suzhou Tuesday after the Chinese New Year holiday. Only 6% of its staff traveled to or through Wuhan, or came in contact with people who were in Wuhan, the company said. It’s continuing to monitor employee health and says enough employees are back to their hometowns to get operations underway.

Another vaccine player has jumped into the fray. German biotech CureVac AG and the Coalition for Epidemic Preparedness Innovations have expanded an existing partnership to research a potential coronavirus vaccine. The agreement adds $8.3 million in funding to their prior deal for accelerated vaccine development, manufacturing and clinical trials.

UPDATED: Tuesday, Feb. 11 at 10:36 a.m. ET

While the World Health Organization is seriously concerned about the situation in China, the outbreak still “holds a very grave threat for the rest of the world,” Director-General Tedros Adhanom Ghebreyesus said in Geneva, as quoted by CBS News. Transmission in other countries could be a “spark” that would light a larger fire, he said. The agency has tracked 393 cases outside of China.

Meanwhile, the agency has sent a team to China to help investigate the outbreak, Reuters reports. The group, which could “range between 10 and 15” people, will be led by Canadian expert Dr. Bruce Aylward, the WHO chief said.

Zhong Nanshan, China’s top adviser on the outbreak, told Reuters he hopes the crisis will be over in April. New case numbers are falling, he said, and he believes the outbreak will peak this month.

UPDATED: Monday, Feb. 10 at 11:42 a.m. ET

As drugmakers scramble together R&D projects, AI-focused firms have used that technology to formulate ideas about which molecules might work to fight the virus, Fast Company reports. Benevolent AI says Lilly’s rheumatoid arthritis med Olumiant carries promise, for instand. And Insilico Medicine, another AI-focused drug discovery company, identified 6 other molecules.

After the World Health Organization on Friday warned of drug shortages due to the outbreak, new FDA commissioner Stephen Hahn said there haven’t been any reported shortages in the U.S., Politico reports. Still, the situation is “fluid,” he noted. The agency has pulled its inspectors out of China.

Meanwhile, India is taking stock of critical drug supplies, the Indian Express reports. China is a major supplier to that country, and on-hand supplies will last two more months, multiple companies told the publication.

Aiming to help with the R&D effort against the virus, two U.K. research agencies have started a £20 million fund, PharmaTimes reports. They’re asking scientists to submit ideas for combatting the virus and awarding money for promising projects. In the U.K., the case count has doubled to 8 and officials have declared an “imminent threat,” Reuters reports.

French biotech Novacyt has applied for emergency approval from the FDA for its coronavirus diagnostic, sending shares up. The company’s share price has tripled so far in 2020.

Meanwhile, the outbreak has kept gaining steam, but some Chinese cities are getting back to work on Monday, the South China Morning Post reports. Companies in Beijing, Shanghai and Shenzhen have been allowed to reopen following an extended holiday for the Chinese New Year. Still, the government asked companies to continue to be flexible, for instance allowing employees to work from home when possible.

UPDATED: Friday, Feb. 7 at 10:57 a.m. ET

The first patient has been dosed in a China clinical trial testing Gilead drug remdesivir’s use against the novel coronavirus. According to investigators, the phase 3 study is divided into two parts—one among mild-to-moderate pneumonia patients and the other in serious cases—and aims to enroll a total of 761 subjects. Patients will be followed for 28 days and readouts are expected as early as April.

Fearing the coronavirus could affect drug supplies from China, U.S. Sens. Marco Rubio and Chris Murphy on Thursday called on FDA Commissioner Stephen Hahn to ensure the quality of the drugs from the country. “[W]e are concerned that the pandemic could impact the FDA’s ability to monitor compliance with good manufacturing standards and the ability for Chinese manufacturers to maintain supplies to meet demand in the United States and the growing demands in China,” they write in a letter (PDF).

After speaking by phone with China’s President Xi Jinping, President Donald Trump turned to Twitter to praise China of its “great discipline.” He said: “We are working closely with China to help.”

South China Agricultural University scientists said that the genome sequence of the novel coronavirus separated from pangolins, a scaly anteater, was 99% identical to that from people. They suggest the animal is “the most likely intermediate host.” But other scientists have doubts of the claim, Reuters reported.

UPDATED: Thursday, Feb. 6 at 11:20 a.m. ET

Gilead’s remdesivir has been identified as one of the most promising treatments against the coronavirus. But a recent move by a Chinese research institute to try to patent the drug’s specific use in 2019-nCoV has drawn controversy. Commenting on the case at an internal company event, Gilead CEO Daniel O’day said the company’s responsibility is to carry out the right clinical programs to determine remdesivir’s efficacy against the virus and to ramp up production if it does so that it can reach as many patients as possible. The “patent is not at the forefront of our mind,” he said. While Gilead has patents on the drug for all of its uses, including coronavirus, the company “will not get into a patent dispute,” he added.

Amid a flurry of commitment from different drugmakers to fight the coronavirus, Sanofi CEO Paul Hudson said the French pharma will unveil a coronavirus initiative of its own within the next two weeks. “We are one of the few companies that has the expertise to know when it is just a fantasy, or when it could be real. In the next week or two, you will see something more confirmatory about the approach we will take,” Hudson said at a news conference on Thursday, as quoted by Reuters.

Li Wenliang, the Chinese doctor who tried to sound an early alarm about the novel coronaivurs but was silenced by local authorities, has passed away.

Bristol-Myers Squibb has limited and restricted employee travel to and from China. At the same time, the New York company said it’s “diligently monitoring manufacturing and supply facilities across the globe,” and that it doesn’t expect any disruptions to the supply of its medicines.

Novo Nordisk has extended the Chinese New Year holiday for its employees in China, following a recent recommendation by the Chinese government. That means Novo doesn’t have sales reps pushing innovative drugs in the field, which could lead to slower growth in the short term, CEO Lars Fruergaard Jørgensen said in an interview.

In other parts of the world, the U.K. has recorded its third coronavirus case. And the number of passengers on a Princess cruise ship in Japan who have tested positive for the coronavirus has grown to 20.

UPDATED: Wednesday, Feb. 5 at 10:02 ET

Looking to stop the spread of coronavirus in the U.S. before it starts, the FDA has granted an emergency authorization to the Centers for Disease Control and Prevention’s (CDC’s) novel coronavirus diagnostic, allowing it to be used at qualified and designated laboratories across the country. Until now, the test could only be used to evaluate samples shipped to the CDC’s own labs, slowing the agency’s turnaround time in responding to the spread of the disease.

How does Regeneron plan to tackle the coronavirus? With the antibody expertise that has served it so well in developing meds such as the blockbuster immunology therapy Dupixent. Not to mention its previous antiviral work, against Ebola and MERS, the new 2019-nCoV’s fellow coronavirus.

In the search for a coronavirus treatment, a Chinese research facility is taking the unusual step of attempting to patent one of Gilead Sciences’ experimental antiviral candidates, remdesivir, that has shown clinical promise. One problem with that approach? Gilead owns the underlying patent and likely isn’t interested in sharing it.

Speaking of remdesivir, the World Health Organization has designated Gilead’s drug as the most promising candidate as a treatment for coronavirus given its strong clinical efficacy. The WHO is also putting a “master protocol” in place to test multiple investigational therapies at once in a move to expedite development.

With some of the major drugmakers stepping in to help develop a new coronavirus treatment, GlaxoSmithKline plans to leverage its pandemic vaccine adjuvant platform to help the cause.

UPDATED: Tuesday, Feb. 4 at 10:23 a.m. ET

Each day, more companies are jumping into the fray. On Tuesday, Regeneron unveiled an expanded partnership with the U.S. Department of Health and Human Services aimed at developing antibodies to fight the new coronavirus.

Swiss contract developer and manufacturer Lonza opted to keep four plants in China closed after its Chinese New Year holiday to help arrest the virus’ spread. It’s also imposing travel restrictions for employees and any who’ve traveled to China will face a two-week quarantine when they return. Story

Experts aren’t sure when the outbreak will peak, Evercore ISI analyst Josh Schimmer wrote in a note following an expert webinar. From this point, possible outcomes include “containment,” or a “massive global pandemic” he wrote in a note to clients. He tallied up 10 pharma companies in the hunt for drugs and vaccines to fight the virus.

Australia’s CSL is exploring the ways it can help, the Sydney Morning Herald reports. The virus doesn’t fall within CSL’s core focus areas, the company said, but it’s still looking at ways it can lend its expertise.

Meanwhile, Hong Kong has recorded its first death and the global case count climbed to more than 20,000, the Wall Street Journal reports.

UPDATED: Monday, Feb. 3 at 9:37 a.m. ET

Another player is jumping into the global vaccine hunt. GlaxoSmithKline and the Coalition for Epidemic Preparedness Innovations unveiled a new partnership that aims to make GSK’s adjuvant technology available to others working on early-stage vaccines. So far, the University of Queensland in Australia has an agreement to use the adjuvant. Story

Aside from vaccine efforts, Gilead is among those working on a potential therapeutic. The company is exploring whether its failed Ebola drug remdesivir could work to treat the infection after the medicine seemed to help the first patient in the U.S. with their infection. The drug is set for further testing in China. Story

As the outbreak intensifies, questions about the global drug supply chain have swirled. If China shuts down its borders or is shunned from international trade, will there be enough supply of pharmaceuticals? Drugmakers say they are prepared. Story

U.S. regulators certainly aren’t taking the threat lightly. New FDA commissioner Stephen Hahn told Politico that while there haven’t yet been reports of supply chain interruptions, he’s preparing for “what could potentially be the most serious of scenarios.” The HHS has declared the outbreak a public health emergency Friday, so the FDA’s role in the emergency will be heightened going forward. Politico story

UPDATED: Friday, Jan. 31 at 8:43 a.m. ET

As of Friday, at least a dozen vaccines and several treatments are in development, BioCentury reports. Almost as soon as the publication published a chart detailing the ongoing work, though, the landscape had changed. Aside from the dozen vaccines listed there, Vaxart unveiled its own program Friday morning.

Meanwhile, Roche says it has developed the first commercial test for the outbreak, Bloomberg reports. The new diagnostic can detect the virus in a few hours, according to the company.

The Institut Pasteur said it had sequenced the entire genome of the virus, formally known as 2019-nCoV, and its scientists have made virus samples available for research. The institute’s announcement follows The Lancet’s publication Thursday of its own sequencing work.

Instead of wearing face masks, the CDC recommends Americans remain “vigilant” about symptoms of the virus, which include fever and cough, and follow typical techniques for combatting the spread of flu, such as washing hands regularly and using hand sanitizer. Still, mask suppliers tell us supplies are running short, and anecdotal reports say at least some retail outlets are out of stock.

In Singapore, it’s a different story as members of the Singapore Armed Forces are packing millions of masks for distribution to the public.

Scientists at the Chinese Academy of Sciences’ Wuhan Institute of Virology and military researchers found that remdesivir, chloroquine and Norvir (ritonavir) exhibit good inhibitory effects on 2019-nCoV at the cellular level. They are now under relevant procedures to gain official approval for clinical use.

UPDATED: Thursday, Jan. 30 at 2:41 p.m. ET

Johnson & Johnson on Wednesday unveiled its “multi-pronged” response that includes a vaccine R&D effort in a “skunkworks” in the Netherlands, according to Chief Scientific Officer Paul Stoffels. It’s also testing whether existing medicines could tackle the novel virus and donating antiviral drugs to Chinese hospitals.

Meanwhile, AbbVie’s HIV drug Kaletra was plucked out by Chinese authorities for use against the pneumonia triggered by the novel virus. AbbVie in turn announced a $1.5 million donation of the drug.

Moderna Therapeutics and Inovio are scrambling to develop vaccines of their own, and local outbreak preparedness group CEPI has pledged funding for their early-stage efforts. The group formed in response to prior outbreaks and has doled out hundreds of millions of dollars for outbreak prep efforts. Inovio and Moderna are only two of the early vaccine efforts that have been announced; Moderna believes its mRNA vaccine technology could “serve as a rapid and flexible platform” to respond to emerging pathogens, including the new coronavirus.

From afar, it can sound like the whole of China has been overtaken by the outbreak of the novel and deadly coronavirus, but Chinese CDMO WuXi Biologics offered some reassurance: It’ll continue to supply the critical drugs it produces for markets around the world. The contractor said its workforce and operations are unaffected, and it’s “working vigilantly to execute our Business Continuity Plan to mitigate any potential risk” and ensure its products are unaffected by the outbreak.

For its part, Roche is running into logistical trouble, thanks to the numerous Chinese cities in lockdown mode. The travel barriers have proven a complication for delivering diagnostic kits, the company said. Meanwhile, China just approved several new diagnostic kits from Sansure Biotech to help detect cases.

To keep its own workforce safe, Sanofi has asked employees to stop travel to and from Wuhan and the Hubei province, Reuters reports, as the case count climbs.

The outbreak continues to spread beyond China, too. As of Thursday, the World Health Organization reported 82 other cases have been confirmed in 18 countries. J&J says cases have been logged in Australia, Cambodia, Canada, France, Germany, Hong Kong, Japan, the U.S. and elsewhere.

The U.S. and Japan have evacuated hundreds of people from China, and other countries are planning similar evacuation flights, AP reports. Americans on the U.S. evacuation flight are undergoing testing at a military base in California.

And about 6,000 people are stuck on a cruise ship off of the coast of Italy as authorities suspect two cases on board.

Posted in: R&D, Vaccines

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