As Coronavirus Threat Continues, Biopharma and Academia Gear Up to Test and Develop Vaccines and Therapies

 

The coronavirus outbreak that causes the COVID-19 disease continues to spread. The U.S. Centers for Disease Control and Prevention (CDC) warned the public yesterday to be prepared for it to spread in the U.S., indicating it was “when,” not “if.” This is in direct conflict with President Trump’s blithe responses, telling reporters in India yesterday, “I think that’s a problem that’s going to go away” and the outbreak “is very well under control in our country.”

Nancy Messonnier, the CDC’s chief immunization officer, told the press, “It’s not so much of a question of if this will happen in this country anymore, but a question of when. We are asking the American public . . . to prepare for the expectation that this is going to be bad.”

The largest outbreak outside of China is in South Korea, which reported 1,300 cases, including a 23-year-old U.S. service member who is self-quarantined in a home off-base. Globally, more than 2,700 people have died of COVID-19, and global stock prices responded with uncertainty, causing share prices to plunge. Italy has confirmed 322 cases of the virus, the highest number of infections outside Asia. The country has also admitted that it mishandled the region’s first case, which contributed to the spread of the virus. The Italian government has placed several cities and towns in the northern region on lockdown, preventing people from entering or leaving affected areas and canceling public events and some facilities, such as museums, to the public. This essentially placed 100,000 people under quarantine.

On the biopharma and response side, the University of Nebraska Medical Center (UNMC) in Omaha with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), have initiated a clinical trial of the Gilead Science’s antiviral drug remdesivir in COVID-19. It was originally developed to treat Ebola and in animal studies showed promise in treating SARS and MERS, which are caused by coronaviruses.

The first patient being treated is an American who was brought back to the U.S. after being quarantined on the Diamond Princess cruise ship docked in Yokohama, Japan. He volunteered to participate. Clinical trials of the drug are also ongoing in China.

Other companies are actively involved as well. It was reported yesterday that Moderna’s coronavirus vaccine shipped to NIAID and clinical trials would begin in April.

UK-based GlaxoSmithKline stated Monday that it was working with China-based Clover Biopharmaceuticals to develop a vaccine candidate.

“We are proud to contribute to cutting edge research from scientists at Clover Biopharmaceuticals in China as part of our strategy to make our adjuvant technology available to selected partners,” said Thomas Breuer, GSK Vaccines’ chief medical officer.

State-owned pharmaceutical companies China Resources Pharmaceutical Group and China Medicine Health Industry Co. are speeding production of chloroquine. This drug appears to be effective in treating the coronavirus with no severe side effects. It has been in clinical use for more than 70 years.

Another study is ongoing of favipiravir compared to AbbVie’s Kaletra, an antiretroviral for HIV. China health officials have recommended broader clinical use of the drug based on 80 coronavirus patients. Zhejiang Hisun Pharmaceutical Co. manufactures favipiravir.

Paris-based Sanofi’s Sanofi Pasteur, its global vaccines business, is collaborating on a vaccine with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response, part of the U.S. Department of Health and Human Services (HHS).

Sanofi plans to continue investigating an advanced preclinical SARS vaccine candidate that it had worked on during the 2002-2003 SARS outbreak. SARS stands for severe acute respiratory syndrome, and is caused by a coronavirus that has some similarities to the COVID-19 virus. The SARS virus mostly disappeared by 2004.

“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.”

Johnson & Johnson is working on drugs for the disease with BARDA, although Monday the company indicated it had no more updates on these programs.

Other companies have drugs in the pipeline:

Innovation Pharmaceuticals is evaluating Brilacidin, what is called a defensin mimetic drug candidate, as a potential treatment for coronavirus. The drug has demonstrated antibacterial, anti-inflammatory and immunomodulatory activity in several clinical trials.

Inovio Pharmaceuticals is collaborating with Beijing Advaccine Biotechnology on Inovio’s vaccine, INO-4800, against the coronavirus. It has launched preclinical testing for clinical product manufacturing. It is supported by a $9 million grant from the Coalition for Epidemic Preparedness Innovations (CEPI). Inovio’s INO-4700, an investigational DNA immunotherapy, is also being developed in partnership with GeneOne Life Science. It was originally developed for MERS.

Vaxart is working on an oral recombinant vaccine using its proprietary oral vaccine platform, VAAST.

CytoDyn is studying leronlimab (PRO 140), a CCR5 antagonist, as a possible treatment. It is being studied in Phase II clinical trials for HIV and the U.S. Food and Drug Administration (FDA) has granted it Fast Track status.

LineaRx, a subsidiary of Applied DNA Sciences, created a joint venture with Takis Biotech on February 7 to develop a linear DNA vaccine for the virus. The joint venture will leverage PCR-based DNA manufacturing technology for the vaccine.

Bioxytran is looking for partners to develop its lead drug candidate, BX-25, as a treatment for Acute Respiratory Distress Syndrome (ARDS) in patients in the later stages of COVID-19. The drug is designed to be 5,000 times smaller than blood cells and helps transport oxygen through the body for about nine hours before being filtered by the liver.

Novavax had developed a vaccine for MERS in 2013. The COVID-19 causing virus has similarities to MERS and SARS.

Biocryst Pharma’s Galidesivir is a broad-spectrum antiviral. It has shown survival benefits in Ebola, Zika, Marburg and Yellow fever.

Regeneron Pharmaceutical’s combination of REGN3048 and REGN3051 is being evaluated in a first-in-human clinical trial sponsored by NIAID. Both antibodies bind to the S-protein of MERS coronavirus.

Meanwhile, the best prevention is thorough and regular hand-washing and avoiding contact with people who are coughing or sneezing.

 

BioSpace source:

https://www.biospace.com/article/coronavirus-update-disconnect-between-trump-administration-and-public-health-experts-and-biopharma-efforts-to-develop-and-test-drugs-and-vaccines