The Corona virus outbreak in the Chinese city Wuhan, also known as COVID-19, and its fast spread to many other countries, endangers millions of lives. The pandemic has facilitated 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.
Pharmaceutical companies involved in developing coronavirus vaccines
We have tried to compile a list of the major coronavirus compositions that pharmaceutical companies across the world are developing that have the potential to become major coronavirus vaccines for treating the contagious coronavirus infection. We will discuss the vaccines in development first, followed by the treatment of choicest drugs that are under development in our second series.
Novel coronavirus vaccines
We have compiled the main vaccines on the CoVid-19 that are patented or is under development.
1 . TJM2 by I-Mab Biopharma
China based 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).
2 . Coronavirus vaccine by Medicago
Quebec , Canada based Medicago is developing plant based 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).
3 . AT-100 by Airway Therapeutics
Ohio based 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.
4 . TZLS-501 by Tiziana Life Sciences
UK based and NASDAQ listed 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.
5 . OYA1 by OyaGen
New York based startup 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.
6 . BPI-002 by BeyondSpring
New York based BeyondSpring’s BPI-002 is a small molecule agent indicated for treating various infections including COVID-19. It has the ability to activate CD4+ helper T cells and CD8+ cytotoxic T cells and generating an immune response in the body.
If combined with another COVID-19 vaccine, the drug has the ability to generate long-term protection against viral infections. BeyondSpring has filed US patent protection for the drug for treating viral infections.
7 . Altimmune’s intranasal coronavirus vaccine
An intranasal Covid-19 vaccine is being developed by Maryland-based clinical-stage biopharmaceutical company, Altimmune.
Design and synthesis of the single-dose vaccine have been completed, while animal testing will follow.
The coronavirus vaccine is being developed based on a vaccine technology platform that is similar to NasoVAX, an influenza vaccine developed by Altimmune.
8 . INO-4800 by Inovio Pharmaceuticals and Beijing Advaccine Biotechnology
Pennsylvania based Inovio Pharmaceuticals has collaborated with Beijing Advaccine Biotechnology Company to advance the development of the former’s vaccine, INO-4800 as a novel coronavirus vaccine. The company has started pre-clinical testing for clinical product manufacturing.
The vaccine development is supported by a $9m grant from the Coalition for Epidemic Preparedness Innovations (CEPI) formed by World Economic forum 2017 in Davos.
Inovio announced an accelerated timeline for the development of the vaccine on 03 March. Preclinical trials are ongoing and the design for human clinical trials have been completed. The company has also prepared 3,000 doses for human clinical trials planned to be conducted across the US, China, and South Korea. Plans for large-scale manufacturing have also been developed.
Human clinical trials in 30 healthy volunteers are expected to commence in April 2020 in the US, followed by China, and South Korea. A phase one clinical trial is planned to be conducted in parallel in China, by Beijing Advaccine. Results from the clinical trials are expected to be available in September 2020.
Inovio aims to produce one million doses of the vaccine by the end of 2020 to perform additional clinical trials for emergency use.
9 . mRNA-1273 vaccine by Moderna and Vaccine Research Center
Massachusetts based Moderna and the Vaccine Research Center, a unit of the National Institute of Allergy and Infectious Diseases (NIAID) have collaborated to develop a vaccine for coronavirus. The vaccine targets the Spike (S) protein of the coronavirus.
The first vials of the vaccine have been manufactured at Moderna’s Massachusetts manufacturing plant and shipped to NIAID for phase one human clinical trial. The trial began on 16 March at the Kaiser Permanente Washington Health Research Institute in Seattle, Washington. A total of 45 males and females, aged between 18 and 45, have been enrolled for the trial.
The participants will be divided into three cohorts who will be administered 25 microgram (mcg), 100mcg or 250mcg of mRNA 1273 dose 28 days apart.
10 .Brilacidin by Innovation Pharmaceuticals
Massachusetts based Innovation Pharmaceuticals announced that it is evaluating Brilacidin a defensin mimetic drug candidate, as a potential treatment for coronavirus. Brilacidin has shown antibacterial, anti-inflammatory and immunomodulatory properties in several clinical trials.
The company is planning to explore research collaborations and seek federal grants to develop the coronavirus drug. It is already investigating the drug for inflammatory bowel disease and oral mucositis in cancer patients.
Innovation has signed two material transfer agreements with a university in the US and 12 biocontainment labs in the US for evaluation of Brilacidin as a treatment for COVID-19. One of the biocontainment labs is scheduled to commence testing of the drug in the third week of March.
11 . Recombinant subunit vaccine by Clover Biopharmaceuticals
China based Clover Biopharmaceuticals is developing a recombinant subunit vaccine using its patented The company is developing the vaccine based on the trimeric S protein (S-Trimer) of the COVID-19 coronavirus, which is responsible for binding with the host cell and causing a viral infection.
Using Trimer-Tag© technology, Clover successfully produced the subunit vaccine in a mammalian cell-culture based expression system on 10 February. The company also identified antigen-specific antibody in the serum of fully recovered patients who were previously infected by the virus.
A highly purified form of the S-Trimer vaccine is expected to be available in six to eight weeks for performing pre-clinical studies. The company is equipped with in-house cGMP biomanufacturing capabilities to scale-up production if the vaccine is proven to be successful.
Clover is also collaborating with GSK to develop a vaccine using the latter’s pandemic adjuvant system.
12 . Avian Coronavirus Infectious Bronchitis Virus (IBV) vaccine by MIGAL Research Institute
The MIGAL Research Institute in Israel announced that an Infectious Bronchitis Virus (IBV) vaccine developed to treat avian coronavirus has been modified to treat COVID-19. The vaccine has demonstrated efficacy in pre-clinical trials conducted by the Volcani Institute.
The IBV vaccine as developed after four years of research and has high genetic similarity to the human coronavirus. The institute has genetically modified the vaccine to treat COVID-19 and will be available in the oral form.
The institute is currently exploring potential partners for producing the vaccine in the next eight to ten weeks and obtaining the necessary safety approvals for in-vivo testing.
13 . Linear DNA Vaccine by Applied DNA Sciences and Takis Biotech
Applied DNA Sciences’ subsidiary LineaRx and Italy based Takis Biotech formed a joint venture on 07 February to develop a linear DNA vaccine as a treatment for coronavirus. The JV will use Polymerase Chain Reaction (PCR)-based DNA manufacturing technology to develop the vaccine.
The PCR technology offers several advantages including high purity, increased production speed, and absence of antibiotics and bacterial contaminants. Further, the vaccine gene developed through this technology can be effective without being inserted into the patient’s genome.
The design for four DNA vaccine candidates is expected to be produced using the PCR technology for carrying out animal testing. The design of one of the vaccine candidates is based on the entire spike gene of the coronavirus, while the remaining are designed based on the antigenic portions of the protein.
14 . BXT-25 by BIOXYTRAN to treat late-stage acute respiratory distress syndrome (ARDS)
Massachusetts based BIOXYTRAN announced that it is exploring partners to develop its lead drug candidate, BXT-25, as a treatment for Acute Respiratory Distress Syndrome (ARDS) in late-stage patients infected with the coronavirus. The diffusion of oxygen to the blood is comprised in patients suffering from ARDS leading to fluid build-up in the lungs.
BX-25 is designed to be 5,000 times smaller than blood cells and efficiently transport oxygen through the body for a period of nine hours before being processed by the liver. The drug can help in supplying oxygen to the vital organs and enable the patient to recover and survive.
MERS CoV vaccines for coronavirus
Middle East respiratory syndrome-related coronavirus, or EMC/2012, is a species of coronavirus which infects humans, bats, and camels.
1 . Novavax’s MERS coronavirus vaccine candidate
Maryland based Novavax developed a novel Middle East Respiratory Syndrome (MERS) coronavirus vaccine candidate in 2013, post the identification of the first MERS coronavirus ((MERS-CoV) in Saudi Arabia in 2012. It is a crucial target for coronavirus vaccine development by the Coalition for Epidemic Preparedness Innovations (CEPI) and is a priority disease for the World Health Organisation (WHO).
The candidate is designed to primarily bind to the major surface S-protein and developed using the company’s recombinant nanoparticle vaccine technology. Tested along with the Novavax’s proprietary adjuvant Matrix-M™, it inhibited infection by inducing immune responses in the laboratory studies.
Novavax has received $4m in funding from CEPI to advance the development of the vaccine. The company has produced several nanoparticle vaccine candidates for testing in animal models and aims to carry out human trials in 2020.
The MERS coronavirus is related to the severe acute respiratory syndrome (SARS) coronavirus, for which the company had previously developed a recombinant nanoparticle vaccine candidate.
2 . Inovio Pharma’s INO-4700
Inovio Pharma haven’t disappointed us in this segment also. It’s investigational DNA immunotherapy, INO-4700 (GLS-5300) is being developed in partnership with GeneOne Life Science. It is delivered as vaccine intramuscularly, using the Cellectra® delivery device.
The company has received a $5m grant from the Bill and Mellinda Gates foundation to accelerate the development of the Cellectra® delivery device.
The vaccine was well-tolerated and demonstrated high immune responses against the MERS-CoV in 94% of patients in the early-stage clinical trial in July 2019.
It also generated broad-based T cell responses in 88% of the subjects.
While most of the world around us is still in a panic mode. These pharmaceutical companies along with many others (who are in the process of filing patents and did not find a mention here) in conjunction with multi-lateral research and funding agencies are in pursuit of a exponential disruption to these global pandemic of Covid-19. However India with an expected $55 Billion Pharmaceutical Industry and Government’s “Pharma Vision 2020” of turning India in to a leading exporter of Pharmaceuticals, lags behind in breaking the R&D ceiling of Covid-19 vaccine development. With a ray of hope for an abundant and healthy future, we will continue with our discussion on the drugs of choice for the CoVid 19 in our next series.
