Today, we are facing a crisis that is unlike anything most of us have seen in our lifetimes. COVID-19 has brought health systems across the world to the fringe and forcefully closed schools, restaurants, events, and many other places around the world where we gather. The pandemic has killed countless lives and caused havoc in the lives of millions of workers. The ramifications of the pandemic are social and economic and will likely be felt for some time to come.
Thankfully, there are remarkable global efforts underway from across the regenerative medicine sector to diagnose, treat and prevent infections from the virus.
Causes of COVID-19’s Rapid Spread
One of the most frequently asked question is how the virus manages to spread so easily. Two recent studies have offered the clues by pinpointing the cell types that express the two key proteins that the virus uses to sneak into cells. They are the cell surface receptor angiotensin-converting enzyme 2 (ACE2) and the enzyme transmembrane protease, serine 2 (TMPRSS2).
Globlet cells and ciliated cells are the two types of nasal cells that are found on the outermost layer of the nasal epithelium which are highly accessible to the virus, during breathing.
Even though SARS, which caused the severe acute respiratory syndrome epidemic of 2002–2003, also used ACE2 to enter host cells, researchers could not previously identify the nasal cells as viral targets.
Impact of the Coronavirus on the Regenerative Medicine Sector
While there is not yet an approved treatment for COVID-19, the scientific, medical and regulatory agencies are making heroic efforts to bring out new medicines. Numerous COVID-19 product categories have emerged, including vaccines, antibodies, antivirals, repurposed drugs, RNA-based drugs, and cell-based therapies, as well as other approaches, such as enzymes, peptides and glycoproteins.
Thousands of scientific articles have been published electronically or in print since the outbreak of COVID-19 began in late 2019. Patent activity around COVID-19 is surging, with most companies securing intellectual property (IP) related to the development of COVID-19 therapeutics. To a lesser degree, companies are securing IP around vaccines, diagnostic agents, and methods.
To accelerate the development of therapies against COVID-19, the repurposing of existing drugs is being explored by numerous market competitors. Barcitinib is being explored because of its anti-inflammatory effect and possible ability to reduce viral entry. A specific dose of the anti-HIV combination, Lopinavir-Nitonavir, is now in clinical trials with Arbidol or Ribavirin. Remdesivir, developed by Gilead Sciences, was earlier tested in patients with Ebola virus and has shown promise in animal models for MERS and SARS.
Remdesivir has reached Phase III in the U.S. and China. Favipiravir, a purine nucleoside leading to inaccurate viral RNA synthesis, was previously developed by Toyama Chemical of Japan, and has now been approved for a clinical trial as a drug for the treatment of COVID-19. Despite enormous controversy, Chloroquine is also being explored for its applications.
Leveraging Prior Expertise with Viruses
Pharmaceutical companies have profound scientific knowledge acquired from decades of experience with similar viruses. Companies are exploring vaccine candidates and undertaking inventories of research portfolio libraries for identifying additional potential treatments for R&D.
Some companies have donated drugs with the potential for treating COVID-19 for emergency use and clinical trials, including compounds previously tested on other viral pathogens such as Ebola and HIV. Some companies are identifying methods to use existing technologies that provide the ability to rapidly upscale production once a potential vaccine candidate is identified.
It has been reported that there are more than 1,000 ongoing clinical trials testing more than 150 treatments as of June 2020. Biotech companies are giving priority to research and development related to COVID-19 diagnostics, treatments, health technologies and vaccines, as well as exploring the potential of existing treatments.
There are also more than 100 confirmed vaccine projects under development globally.
About eight of these projects are in clinical trials. Almost 72% of confirmed vaccine projects are being sponsored by the pharmaceutical industry with the remaining 28% receiving support from the academic, public sector and other non-profit organizations (NPOs). Industry experts anticipate that it will take a minimum of 12 to 18 months before there is a vaccine available.
Developing New Diagnostics
Developing new diagnostics for the detection of COVID-19 is an important step in preventing or slowing the spread of the disease. The galloping speed of the COVID-19 spread has drastically increased the demand for testing kits around the world, particularly in the U.S. and Europe, and governments across the world are trying to ramp up their testing capacities.
Thankfully, new diagnostic tests for COVID-19 have emerged as an essential tool to track the spread of the disease, as the World Health Organization (WHO) urged health agencies worldwide to make testing for the virus a top priority.
As of June 2020, the FDA granted Emergency Use Authorization (EUA) for 58 viral RNA-based tests, ten antibody-based tests, one antigen-based test and one home collection kit.
In addition to the efforts of individual companies, a consortium of life sciences companies – including BD, bioMérieux, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Eli Lilly, Gilead, GSK, Johnson & Johnson, Merck, Novartis, Pfizer, and Sanofi – are taking efforts to accelerate the development, manufacture and delivery of vaccines, diagnostics and treatments for COVID-19. This consortium was organized in partnership with the Bill & Melinda Gates Foundation.
Interested to learn more about the evolving COVID-19 pandemic and the market opportunities it is creating within the regenerative medicine sector?