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Information On Vaccines, Drugs And Diagnostics For Coronavirus

February 15, 2020,

More companies make coronavirus commitments

Mentions:2019-nCoV, vaccines, CEPI, GSK, CureVac, mRNA, Inovio, Sanofi, Institut Pasteur, ExpreS2ion Bio, Vaxart, iBio, WHO, Gilead, AbbVie, Regeneron, Biotron, BenevolentAI, Eli Lilly, Incyte, BGI, FDA, Public Health England, Novacyt, Co-Diagnostics, HHS, BMGF

February 8, 2020 — Pharma companies continued the rush of product development announcements this week as novel coronavirus (2019-nCoV) cases continued to spread in China and internationally.

Vaccines

On vaccines, the Coalition for Epidemic Preparedness Innovations (CEPI) more than doubled its number of current 2019-nCoV announcements over the past eight days. Firstly, CEPI said it has agreed with GSK to make the company’s adjuvant available to groups that CEPI is funding to develop vaccine candidates. Next, CEPI announced it is giving $8.3 million to CureVac to develop messenger RNA-based candidates—an addition to its existing grant to the German biotech. Meanwhile, CEPI also announced that Britain has given it $25.8 million in additional support to help combat the outbreak. Finally, CEPI launched a call for proposals from any qualified organization—nonprofit, for-profit, government or academic—willing to support “equitable access” to new coronavirus vaccines.

In related news, Inovio announced last week that it will work with Beijing Advaccine Biotechnology to put the Pennsylvania company’s DNA-based, CEPI-funded vaccine candidate through Phase 1 in China, while Reuters reported Thursday that Sanofi would share its “expertise and data” with CEPI and announce “a new coronavirus initiative within the next two weeks.”

Beyond CEPI, France’s Institut Pasteur announced last week that it had isolated a strain of 2019-nCoV detected in France, sequencing the whole viral genome. Reuters added that the nonprofit “is looking into developing a vaccine,” expecting work to take 20 months.

Meanwhile, Denmark’s ExpreS2ion Bio announced Thursday that it would use its Drosophila S2 insect cell expression system to develop a 2019-nCoV vaccine, saying it hoped to produce and test antigens in mice within 2-3 months.

Not to be outdone, California’s Vaxart also announced last week that it will develop an oral recombinant vaccine, while iBio said that it is working with Beijing CC-Pharming Ltd on a vaccine. The Texas-based company provided few details, but saw its stock rise 70 percent on the news (to 46 cents).

Drugs

On drugs, a WHO working group named Gilead’s investigational antiviral remdesivir as “the most promising candidate” for coronavirus drug R&D in a draft blueprint circulated last week. A coronavirus patient in Washington State also markedly improved after intravenous treatment with remdesivir on a compassionate-use basis,  

The New England Journal of Medicine reported last week. Meanwhile, in a letter published Tuesday in the journal Cell Research, researchers at the Wuhan Institute of Virology (WIV) announced promising in vitro results from using remdesivir and the antimalarial chloroquine—each of which proved individually “highly effective” against 2019-nCoV.

Reuters reported Tuesday that WIV also took the opportunity to apply for a patent on the use of remdesivir against 2019-nCoV. Finally, Bloomberg reported Sunday that a medical team from Beijing’s China-Japan Friendship Hospital will “speedily” commence human tests of remdesivir in a randomized, double-blind, placebo-controlled study, with The New York Times adding Thursday that enrollment had already begun.

In other coronavirus drug news, Reuters reported Sunday that Thai doctors “have seen success” treating 2019-nCoV cases with AbbVie’s HIV drugs lopinavir and ritonavir in combination with flu drug oseltamivir “in large doses.” Chinese researchers said in an article in The Lancet last month that a hospital in Wuhan has also “quickly initiated” a randomized controlled human trial of lopinavir and ritonavir.

Meanwhile, Regeneron announced on Tuesday that it is expanding its existing agreement with the U.S. Biomedical Advanced Research and Development Authority (BARDA) by adding 2019-nCoV to the list of pathogens the company is using government funding to target, although the New York-based biotech did not say whether BARDA is offering any additional money.

Finally, Australia’s Biotron announced imminent plans to test small-molecule compounds—previously shown to have “broad-spectrum activity” against other coronaviruses—on 2019-nCoV, while The Lancet published a study analyzing data from BenevolentAI’s medical database which found that Eli Lilly’s and Incyte’s rheumatoid arthritis drug baricitinib “might block the viral infection process” for the disease.

Diagnostics

On diagnostics, China’s BGI announced last week that it has produced 50,000 “real-time” coronavirus tests, which the press release said yield 2019-nCoV results “in a few hours.” The company also announced that it is developing a “metagenomic sequencing detection kit” that it says can monitor mutations and—in a separate release this week—said its new Wuhan-based laboratory is now ready to screen 10,000 samples daily for the disease.

Meanwhile, the U.S. FDA issued an emergency use authorization (EUA) on Tuesday for a reverse transcriptase polymerase chain reaction (RT-PCR) 2019-nCoV diagnostic from the U.S. Centers for Disease Control and Prevention (CDC). Reuters said that the move will allow state laboratories to begin conducting tests on their own rather than having to send samples to CDC. The FDA said that several additional diagnostics developers “have already requested and received the EUA template for this outbreak.”

In a similar move, Public Health England announced yesterday that it will distribute its own diagnostic—currently available only in one lab in London—to 12 facilities across the United Kingdom, beginning next week.

Anglo-French clinical diagnostics company Novacyt also announced plans yesterday to secure an EUA for its Primerdesign coronavirus diagnostic, which detects “only the 2019 strain of the virus,” gives results in under two hours, and is thermostable, according to the press release. The company also said it expects the test to qualify for CE marking within two weeks.

Finally, Utah-based Co-Diagnostics last week announced “successful initial verification” of a new 2019-nCoV screening test, while the journal Clinical Chemistry published research last week from Hong Kong identifying two “real-time” RT-PCR assays that quickly detect the disease.

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In other news (and in addition to the Gates Foundation’s increase in coronavirus funding to $100 million), WHO announced Thursday that it would co-host a “global research and innovation forum” next week in Geneva—a joint effort with the Global Research Collaboration for Infectious Disease Preparedness.

The U.S. Department of Health and Human Services also last week issued a public health emergency declaration over the outbreak.
MORE INFORMATION:

Vaccines 
CEPI-GSK joint press release
CEPI-CureVac joint press release
CEPI press release on UK funding
CEPI call for proposals
Inovio press release
Reuters Sanofi article
Institut Pasteur press release
Reuters Pasteur article
ExpreS2ion press release
Vaxart press release
iBio press release

Drugs
WHO draft R&D blueprint
New England Journal of Medicine article
Cell Research letter
Reuters remdesivir article
Bloomberg remdesivir article
The New York Times remdesivir article
Reuters lopinavir/ritonavir article
The Lancet lopinavir/ritonavir article
Regeneron press release
Biotron press release
The Lancet baricitinib article

Diagnostics
BGI press release on diagnostics
BGI press release on Wuhan lab
FDA press release
Reuters diagnostics article
Public Health England press release
Novacyt press release
Co-Diagnostics press release
Clinical Chemistry article