By Gordon Pape, Editor and Publisher
The race is on to develop a vaccine against the novel coronavirus. The prize could be countless lives saved and perhaps billions of dollars in revenue.
The situation is growing more acute by the day. Italy has closed its borders been in an effort to contain a localized outbreak. Other European countries, including Germany, are reporting cases.
Nancy Messionnier of the U.S. Centers for Disease Control warned that it is only a matter of time before the virus gets a foothold in that country. President Trump has dismissed the possibility, suggesting that everything would work out fine. Who do you think has more credibility here?
If the U.S. succumbs, Canada will be close behind. If the examples of China and Italy are a forerunner of what might happen here, expect locked-down cities, school closings, cancelled sports events, factory shutdowns, empty grocery shelves, and economic gridlock.
Normally, it takes years for the U.S. Food and Drug Administration (FDA) to approve new drugs or vaccines. Every new product is subject to rigorous tests and clinical trials before receiving approval.
In serious situations like this, the FDA would certainly fast-track any promising cure or vaccine that is submitted. But even that implies a lengthy delay.
Many companies are racing to be the first out of the gate. Here are some of them.
Moderna Inc. (NDQ: MRNA)
This biotech company based in Cambridge, Massachusetts appears to have been the first to submit a vaccine for testing. It specializes in RNA (ribonucleic acid) Science – RNA carries the genetic information of many viruses and can be used to create the codes to neutralize them.
On Feb. 24, the company announced it had released the first batch of mRNA-1273, its vaccine against the novel coronavirus, for human use. Vials of the vaccine have been shipped to the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), to be used in a planned Phase 1 study in the U.S.
The test batch was delivered in 42 days from sequence identification, said Juan Andres, chief technical operations and quality officer at Moderna. Tests are expected to start in April, but the process could take up to a year. One of the problems is that RNA vaccines are a new technology that has not yet been approved by the FDA.
Although Moderna posted a loss in 2019, shares of the company shot up on the news. While the rest of the market was tanking, the stock hit an all-time high of US$29.98 in heavy trading on Feb. 26. But it couldn’t withstand the meltdown over the next two days and closed on Friday at US$25.93.
Inovio Pharmaceuticals (NDQ: INO)
This Pennsylvania-based company is unknown to most investors, but it is on the leading edge of developing therapies for cancers and infectious diseases using DNA sequencing.
Shortly after the coronavirus outbreak came to public attention, the company announced it has been awarded a $9 million grant by the Coalition for Epidemic Preparedness Innovations (CEPI) to develop a vaccine. The money will be used to support Inovio’s preclinical and clinical development through Phase 1 human testing of INO-4800, the new coronavirus vaccine it has matched to the outbreak strain.
Inovio was the first to advance its vaccine (INO-4700) against MERS-CoV, a related coronavirus, into evaluation in humans. Inovio is currently preparing to initiate a Phase 2 vaccine trial for INO-4700 in the Middle East where most MERS viral outbreaks have occurred. (MERS stands for Middle East Respiratory Syndrome).
“The world needs to act quickly and in unity to tackle this disease,” said Richard Hatchett, CEPI’s CEO. “Our intention with this work is to leverage our work with Inovio on the MERS coronavirus and rapid response platform to speed up vaccine development.”
Inovio’s stock hit a one-year high of US$5.95 after the news of the grant was announced but it has since slipped back. It closed on Friday at US$4.28.
Sanofi (NDQ: SNY)
Paris-based Sanofi Pasteur, the vaccines global business unit of Sanofi, is joining forces with U.S. Department of Health and Human Services (HHS) to advance a novel coronavirus vaccine.
On Feb. 18, the company announced it will leverage previous development work for a SARS vaccine in an effort to unlock a fast path forward for developing a COVID-19 vaccine. Sanofi will collaborate with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response, expanding the company’s long-standing partnership with BARDA.
“Addressing a global health threat such as this newest coronavirus is going to take a collaborative effort, which is why we are working with BARDA to quickly advance a potential vaccine candidate,” said David Loew, Global Head of Vaccines at Sanofi.
“While we are lending our expertise where possible, we believe the collaboration with BARDA may provide the most meaningful results in protecting the public from this latest outbreak.”
Sanofi will use its recombinant DNA platform to produce a novel coronavirus vaccine candidate. This technology produces an exact genetic match to proteins found on the surface of the virus, the company said. From there, an antigen can be developed to provide immune system protection against the virus.
But even with a leg up after its work on SARS, we’re not looking at a quick fix here. John Shiver, the head of the company’s vaccine research and development team, said that even with fast-tracking it would probably be three to four years before a product is generally available. By then, the virus may have run its course.
Nonetheless, Sanofi stock (which trades on Nasdaq as American Depository Shares) closed Friday at US$46.25.
Regeneron Pharmaceuticals (NDQ: REGN)
This biotech company, based in New York State, has announced an expanded agreement with HHS to develop new treatments to combat the novel coronavirus, working through BARDA.
The company had been working with the federal agency since 2017 on researching and developing a portfolio of antibodies targeting up to 10 pathogens that pose a significant risk to public health. The extended arrangement will target the novel coronavirus, using the company’s proprietary technologies.
The focus will be on Regeneron’s VelocImmune platform, which uses a unique genetically-engineered mouse with a humanized immune system that can be challenged with all or parts of a virus of interest. This can speed up the process of identification, preclinical validation, and development of promising antibody candidates.
The company says its systems are particularly well-suited for use in quickly-developing outbreak situations, as was done for Ebola.
Regeneron was founded 30 years ago by a team of physicians-scientists. It develops products for patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain, and rare diseases.
It generated revenue of US$7.9 billion in 2019, up 17% from the prior year. GAAP net income was US$2.1 billion (US$18.48 per share). The stock does not pay a dividend. The shares bucked the downtrend to gain US$12.96 on Friday, closing at US$444.57.
Gilead Sciences (NDQ: GILD)
This major biopharmaceutical company announced on Wednesday that it is launching two phase 3 clinical studies to determine whether its anti-viral drug remdesivir can safely and effectively treat people with COVID-19.
The initiation of these studies follows the FDA’s rapid review and acceptance of Gilead’s investigational new drug filing for remdesivir for the treatment of the new disease.
The new studies expand the ongoing research into remdesivir. These include two clinical trials in China’s Hubei province (where the novel coronavirus originated) led by the China-Japan Friendship Hospital as well as the recently initiated clinical trial in the United States led by NIAID. Gilead has donated drugs and provided scientific input for these studies, with results from those in China expected in April.
Remdesivir is an experimental antiviral drug, designed to be used against emerging viral pathogens including Ebola, Marburg, MERS, and SARS. It has not been licenced for use anywhere in the world to this point. The tests are being done on a compassionate use basis for emergency treatment. If it is proved to be effective, it would be used as a cure for patients, not a vaccine for prevention.
The first of two new studies will evaluate the safety and efficacy of both a 5-day and a 10-day dosing regimen of remdesivir, administered intravenously in patients with severe cases of COVID-19. It will involve about 400 people.
The second study will look at the effect of the drug on people with more moderate symptoms of the disease. It will test about 600 infected people.
Gilead stock jumped by US$8.58 to a 52-week high after the news of the tests was announced, although it pulled back later.
Many other companies have set up research teams to find a vaccine, but Gilead appears to be the front-runner in terms of a potential cure with a drug that already exists. At this point, the long delays in obtaining approval mean there will be no immediate vaccine. But if Gilead’s clinical trials are successful there may be hope for a treatment within a shorter time frame.
Gilead already has a track record of developing medicines for a wide range of diseases, ranging from HIV-AIDs to cardiovascular disorders. The company generated sales of US$22.1 billion in 2019 and reported diluted earnings per share of US$4.22 based on GAAP standards. The company recently raised its quarterly dividend to US$0.68 (US$2.72 per year), to yield 3.9% based on Friday’s closing price of US$69.36. The p/e ratio is16.44.
This article originally appeared in the Internet Wealth Builder newsletter.