The mysterious coronavirus outbreak in the Chinese city Wuhan, now termed as COVID-19, and its fast spread to many other countries, endangers thousands of lives. The pandemic has catalysed the development of novel coronavirus vaccines across the biotech industry, both by pharmaceutical companies and research organisations such as the National Institutes of Health (NIH), US.
The first COVID-19 vaccine in China is expected to be ready for clinical trials by the end of April, according to Xu Nanping, China’s vice-minister of science and technology. Inovio Pharmaceuticals plans to begin clinical trials on a coronavirus vaccine in April this year.
Health officials from WHO have noted that Gilead’s remdesivir has demonstrated efficacy in treating the coronavirus infection.
Chloroquine approved for emergency use by US FDA
The US Food and Drug Administration (FDA) approved limited emergency use for chloroquine and hydroxychloroquine as a treatment for COVID-19.
The President of the United States, Donald Trump, had announced on 19 March that chloroquine and hydroxychloroquine/Plaquenil, used to treat malaria and arthritis, were approved by the FDA to be tested as a treatment for COVID-19.
Chloroquine is being tested in various clinical trials conducted by government agencies and academic institutions. Other antivirals drugs are also planned to be fast-tracked for testing for coronavirus.
Favilavir, the first approved coronavirus drug in China
The National Medical Products Administration of China has approved the use of Favilavir, an anti-viral drug, as a treatment for coronavirus. The drug has reportedly shown efficacy in treating the disease with minimal side effects in a clinical trial involving 70 patients. The clinical trial is being conducted in Shenzhen, Guangdong province.
Pharmaceutical companies involved in developing coronavirus drugs/vaccines
Here is a list of the major coronavirus drugs that pharmaceutical companies across the world are developing that have the potential to become major coronavirus vaccines or antivirals for treating the contagious coronavirus infection.
Novel coronavirus vaccines
Listed below are the coronavirus vaccines in various stages of development, across the world.
Fusogenix DNA vaccine by Entos Pharmaceuticals
Entos Pharmaceuticals is developing Fusogenix DNA vaccine developed using the Fusogenix drug delivery platform to prevent COVID-19 infections. Fusogenix drug delivery platform is a proteo-lipid vehicle that introduces genetic payload directly into the cells.
Entos is working on developing an optimised payload containing multiple protein epitopes derived from SARS-COV-2 proteins, which will stimulate an immune response in the body to prevent COVID-19 infection.
ChAdOx1 nCoV-19 by University of Oxford
The University of Oxford’s ChAdOx1 nCoV-19 is an adenovirus vaccine vector developed by the university’s Jenner Institute. The university is testing the vaccine in a clinical trial planned to be conducted in the Thames Valley Region.
Approximately 510 volunteers aged between 18 years and 55 years will be enrolled for the study.
Gimsilumab by Roivant Sciences
Roivant Sciences is advancing the development of Gimsilumab a clinical-stage, human monoclonal antibody. The drug targets granulocyte-macrophage colony stimulating factor (GM-CSF), which is a pro-inflammatory cytokine found in high levels in the serum of COVID-19 patients.
Targeting GM-CSF is expected to reduce lung damage and reduce mortality rate in COVID-19 patients.
AdCOVID by Altimmune
Altimmune has collaborated with the University of Alabama at Birmingham (UAB) to develop a single dose intranasal vaccine for COVID-19 named AdCOVID. The company is currently carrying out immunogenicity studies after, which phase one clinical trial material will be developed.
Altimmune and UAB will work with researchers to conduct preclinical animal studies and phase one clinical trial in the third quarter of 2020.
TJM2 by I-Mab Biopharma
I-Mab Biopharma is developed TJM2, a neutralising antibody, as a treatment for cytokine storm in patients suffering from a severe case of coronavirus infection. The drug targets the human granulocyte-macrophage colony-stimulating factor (GM-CSF), which is responsible for acute and chronic inflammation.
The company will commence development after receiving approval for the Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA).
Coronavirus vaccine by Medicago
Medicago is developing drug candidates against COVID-19 after having produced Virus-Like Particles (VLP) of the coronavirus. The company has formed a collaboration with Laval University’s Infectious Disease Research Centre to develop antibodies against SARS-CoV-2.
The company’s research activities are being partly funded by the Canadian Institutes for Health Research (CIHR).
AT-100 by Airway Therapeutics
Airway Therapeutics is exploring its novel human recombinant protein named AT-100 (rhSP-D) as a treatment for coronavirus. The company has announced a filing with the Respiratory Diseases Branch of the National Institutes of Health to evaluate the drug.
AT-100 has shown efficacy in preclinical studies in reducing inflammation and infection in the lungs, while also generating an immune response against various respiratory diseases.
TZLS-501 by Tiziana Life Sciences
Tiziana Life Sciences is developing its monoclonal antibody named TZLS-501 for the treatment of COVID-19. TZLS-501 is a human anti-interleukin-6 receptor (IL-6R), which helps in preventing lung damage and elevated levels of IL-6.
The drug works by binding to IL-6R and depleting the amount of IL-6 circulating in the body thereby reducing chronic lung inflammation.
OYA1 by OyaGen
OyaGen’s OYA1 has shown strong antiviral efficacy against coronavirus in laboratory essays. It was found to be more effective than chlorpromazine HCl in inhibiting SARS-CoV-2 from replicating in cell culture.
OYA1 was earlier approved as an investigational new drug for treating cancer but abandoned due to lack of efficacy. OyaGen plans to conduct further research on the drug to determine the efficacy in treating coronavirus.
Vaxart’s coronavirus vaccine
Vaxart is developing an oral recombinant vaccine in tablet formulation using its proprietary oral vaccine platform, VAAST.
The company plans to develop vaccines based on the published genome of 2019-nCOV to be tested in pre-clinical models for mucosal and systemic immune responses.
CytoDyn-leronlimab
CytoDyn is examining leronlimab (PRO 140), a CCR5 antagonist, as a potential coronavirus drug.
The drug is already being investigated in phase two clinical trials as a treatment for HIV and has been awarded fast-track approval status by the United States Food and Drug Administration.
“Research organisations such as the National Institutes of Health (NIH), US are also developing a vaccine for the coronavirus.”
Coronavirus drugs
The novel coronavirus drugs in various stages of development globally are listed below.
Remdesivir (GS-5734) by Gilead Sciences
An ebola drug developed by Gilead Sciences that was found to be ineffective is now being tested in two phase III randomised clinical trials in Asian countries.
The trials are being performed on 761 patients in a randomised, placebo-controlled, double-blind study at multiple hospitals in Wuhan, the epicentre of the novel coronavirus outbreak. The results from the trials are expected to be available over the next few weeks.
According to a report by The New England Journal of Medicine (NEJM), remdesivir, when administered to a coronavirus patient in the US, appeared to have improved the clinical condition.
The University of Nebraska Medical Center is also carrying out clinical trials to test the safety and efficacy of the drug. The first patient to be administered the drug is an evacuee from the Diamond Princess cruise ship.