COVID-19 – Q&A

The Immunomic team is proud to be a part of the global Biopharma community’s commitment to rapidly develop therapeutics, diagnostics and vaccines to fight the COVID-19 public health crisis.  COVID-19 background information and resources on the disease and Biopharma’s response follow.

Disease Overview

What is the novel coronavirus?

Coronaviruses are a large family of viruses that may cause illness in animals or humans. In humans, several coronaviruses are known to cause respiratory infections ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). The most recently discovered coronavirus causing coronavirus disease is COVID-19.

What is COVID-19?

COVID-19 is an infectious disease caused by the most recently discovered coronavirus. This new virus and disease were unknown before the outbreak began in Wuhan, China, in December 2019.

How does COVID-19 spread?

People can catch COVID-19 from others who have the virus. The disease can spread from person to person through small droplets from the nose or mouth which are spread when a person with COVID-19 coughs or exhales. These droplets land on objects and surfaces around the person. Other people then catch COVID-19 by touching these objects or surfaces, then touching their eyes, nose or mouth. People can also catch COVID-19 if they breathe in droplets from a person with COVID-19 who coughs out or exhales droplets.

Can the virus be transmitted through the air?

Studies to date suggest that the virus that causes COVID-19 is mainly transmitted through contact with respiratory droplets rather than through the air.

Are there any available therapies for COVID-19?

There is no evidence that current medicine can prevent or cure the disease, including antibiotics, as a prevention or cure for COVID-19. However, there are several ongoing clinical trials that include both western and traditional medicines.

Are there any vaccines for COVID-19?

Not yet. To date, there is no vaccine and no specific antiviral medicine to prevent or treat COVID-2019. However, those affected should receive care to relieve symptoms. People with serious illness should be hospitalized. Most patients recover thanks to supportive care. Possible vaccines and some specific drug treatments are under investigation including by Immunomics.

Is COVID-19 considered a pandemic?

Yes, the CDC is characterizing this as a pandemic of a respiratory disease spread. A pandemic is a global outbreak of disease. Pandemics happen when a new virus emerges to infect people and can spread between people sustainably. Because there is little to no pre-existing immunity against the new virus, it spreads worldwide. With more than 400,000 cases confirmed in countries all over the world, the World Health Organization has declared the virus to be a global pandemic, meaning that it will have a sustained global impact.

How many cases are there and how widespread is the outbreak?

The numbers right now are very fluid and are changing every day. They are being tallied in real time in the US and outside the US. In the US, all 50 states have reported cases and are reporting some form of community spread (https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html). The United States has the highest number of cases and China, Italy, UA, Spain, Germany, Iran, France, Switzerland, S. Korea, UK, Netherlands, Austria, Belgium, Norway, Portugal, Sweden have high rates of confirmed cases, and almost all other countries have confirmed cases (https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/world-map.html).

Impact on Biotech Companies and Clinical Trials

How has the COVID-19 pandemic affected companies’ clinical trials and the enrollment/recruitment of these trials?

The downstream impact for patients and the drug industry will be substantial, even if regulatory agencies like the Food and Drug Administration provide help (https://www.fda.gov/media/136238/download). Without data from pivotal clinical trials, new drug filings will be delayed, meaning some important new medicines will take longer to reach the market. While we don’t know how many clinical trials will be affected by this, there are 120 Phase 3 clinical trials being conducted by biotech and pharma companies with market values greater than 300M, and all studies are expected to report top line results by year end, 2020. Eli Lilly recently made a major announcement saying that it will delay the start of new clinical trials and suspend enrollment in most ongoing studies. Trials in which patient enrollment has already been completed will continue. Lilly is listed as the sponsor of 86 clinical trials currently enrolling patients, including 30 in Phase 3, according to ClinicalTrials.gov. Another 78 studies are active but no longer recruiting patients.

An updated list of clinical trials affected can be found here: https://www.biopharmadive.com/news/coronavirus-clinical-trial-disruption-biotech pharma/574609/.

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