The emergence of a novel coronavirus, SARS-CoV-2, in January 2020 has resulted in the declaration of a global pandemic. Innovations in a wide range of technological fields are being progressed at an unprecedented level in response to the crisis and in certain circumstances by unusual collaborations between usually competing companies and/or research organisations.

We have prepared a series of articles detailing some of the technologies being developed to address the COVID-19 crisis and some thoughts on other technologies that may be utilised in the future.

The first article in our series relates to the treatment of COVID-19 disease and possible vaccine candidates for use as a prophylactic. The COVID-19 pandemic has resulted in innovations in various areas, including repurposing of existing authorised drug products, new vaccine candidates and the gathering of data to identify the most promising candidates.

What timeframes are we working to?

The COVID-19 pandemic has resulted in timeframes for vaccine candidate development being shortened significantly compared to usual time lines for vaccine development. Clinical trials are being designed at unprecedented speed and flexibility, with parameters being altered in on-going trials prompted by clinical observations and data. Additionally, the WHO has initiated a global clinical trial of multiple drug candidates in an attempt to significantly shorten the time it takes to test a drug candidate for efficacy. The “SOLIDARITY” clinical trial has utilised a single online platform for hospitals and other health care providers to register patients and record outcomes of the randomised trials.

The global pursuit of a safe and efficacious COVID-19 vaccine is reflected in the World Health Organisation’s list of candidate vaccines, which currently stands at over 100, with technology platforms ranging from DNA-/RNA-based formulations to purified inactivated virus.

When will we see clinical trials?

There seems to be a big science approach to this endeavour, with many candidates moving into human clinical testing at an unprecedented speed. For example, ChAdOx1 nCoV-19, developed by researchers at the University of Oxford, has recently entered a six-month phase I/II clinical trial to assess safety and efficacy. Contributing to the speed at which the vaccine could enter human trials is the fact that the product is based on existing technology. The UK Government has pledged £20 million to support the clinical trials. Furthermore, it was announced on 30 April 2020 that Astra Zeneca has agreed to mass produce the Oxford University vaccine should it prove to be effective.

This vaccine utilises an inert form of an adenovirus (ChAdOx1) as a vector to facilitate the delivery of genetic material encoding the ‘SARS-CoV-2 spike protein’. Studies have previously reported the ‘spike protein’ is required for the mechanism employed by the virus to infect cells. As a result, the vaccine primes the body’s adaptive immune system against the COVID-19 virus. The fact that the product is based on existing vaccine technology has contributed to the speed at which the product can be tested in humans.

Other vaccine candidates are entering human clinical trials at previously unseen speed. The German regulator has recently authorised clinical trials on products being developed by BioNTech and Pfizer. These products are based on different mRNA formats against different SARS-CoV-2 antigens. Moderna is also developing a mRNA vaccine candidate which has entered human clinical trials, with Phase II trials being planned for the second quarter of 2020.

Repurposing Existing Drugs

It remains to be seen whether this accelerated R&D effort will be followed by the rapid regulatory approvals and scaling of manufacturing necessary to get those in need a safe and effective vaccine.

Given the considerable length of time it takes for a drug candidate to be authorised, effort has been largely focussed on repurposing existing drugs to treat COVID-19. These drugs will already have been subjected to stringent safety testing and therefore the timelines for approval can be shortened.

One class of drug being considered for the treatment of COVID-19 is immunosuppressants. Although a functioning immune system is paramount to the body’s ability to overcome a viral infection, current clinical data indicates that an overactive immune response might in fact contribute to the decline and death of patients infected with COVID-19.

Specifically, hyperinflammation resulting from a huge release of cytokines can damage healthy lung cells and exacerbate COVID-19 symptoms. Perceived complications associated with this “cytokine storm” have led to the use of immunosuppressants to dampen the inflammatory immune response. However, there are understandable concerns about the use of any broad-acting immunosuppressants on patients with viral infections. Yet specific cytokine-targeting drugs, which do not completely suppress the immune system, could prove beneficial to COVID-19 patients.

In China for instance, Roche’s Interleukin 6 inhibitor ‘Actemra’ (tocilizumab) – originally used in the treatment of rheumatoid arthritis – has been approved to treat COVID-19 patients. The FDA has recently approved a phase III clinical trial of Actemra. Other possible immunosuppressants being considered include corticosteroids and JAK inhibitors such as Tofacitinib.

Various antiviral candidates are also being tested for efficacy in treating COVID-19. Very recently, data from clinical trials in the US indicates that remdesivir, a nucleotide analog with broad-spectrum antiviral activity owned by Gilead Sciences Inc., has shown efficacy in reducing the length of recovery of patients hospitalised with COVID-19. Its effect on death rates has not yet been determined. Interestingly, it has been reported that the Wuhan Institute, China, filed a patent application in January 2020 covering the use of remdesivir to treat COVID-19.

In conclusion, the urgent need for treatments, diagnostic tools and vaccines to help curb the COVID-19 pandemic has triggered a global R&D effort. This international collaboration was personified on 24 April 2020, with governments, global health actors and philanthropists from around the world founding the landmark “Access to COVID-19 Tools (ACT) Accelerator”, the details of which can be found here: https://www.who.int/who-documents-detail/access-to-covid-19-tools-(act)-accelerator

For further information regarding intellectual property related to potential COVID-19 treatments, please contact Charlotte Watkins at docketing@secerna.com