- US-based drugmaker Gilead is racing against time to develop a treatment for COVID-19 with its anti-viral drug Remdesivir.
- Gilead’s remdesivir granted regulatory approval by the Japanese Ministry of Health, Labour and Welfare for treatment of COVID-19.
- BioNtech and Pfizer are working in collaboration for development and commercialization of COVID-19 vaccine.
- Johnson & Johnson is working collaboratively with Emergent BioSolutions for COVID-19 vaccine, Phase 1 human clinical study to commence in September 2020.
Around the world, while dealing with the novel coronavirus, a billion-dollar question that pop up is how close are we to achieving a cure for this virus?
Let’s find out-
Pharmaceutical and biotech companies are responding quickly to produce an effective COVID-19 vaccine. The race to manufacture a vaccine against COVID-19 is the one that has seen the most competition. Even though many of the vaccines or treatments are still have a long way to go before they are available, still it is worth having a look through what is happening in developing a cure for coronavirus.
In this article, we will acquaint you with the companies leading the way with treatments and vaccines for the COVID-19.
- Gilead Sciences, Inc. (NASDAQ:GILD)
US-based biopharmaceutical company Gilead Sciences is engaged in the development as well as commercialisation of innovative medicines for life-threatening diseases having unmet medical need. Primarily, the Company is focused on developing treatments for liver disease, HIV, AIDS, and serious cardiovascular & respiratory ailments.
In late April-2020, Gilead disclosed that its drug remdesivir has reported positive results in the SIMPLE trial which is an open-label, Phase III clinical study.
On 1 May 2020, GILD revealed that Remdesivir received the US FDA Emergency Use Authorization (EUA) for COVID-19 treatment.
Gilead receives Japanese approval for remdesivir-
It is noteworthy to mention that Gilead’s remdesivir under the Trade name Veklury® was approved in Japan by the Japanese Ministry of Health, Labour and Welfare (MHLW) for treatment of COVID-19.
On 27 May 2020, stock of GILD rose by 2.35% to close the market session at USD 74.90.
- BioNTech SE (NASDAQ:BNTX)
A next generation immunotherapy company BioNTech is engaged in developing groundbreaking novel therapies for cancer and other severe diseases.
On 5 May 2020, BioNTech and Pfizer disclosed that the first participants for the BNT162 vaccine program to prevent COVID-19 have been dosed in the United States in the Phase 1/2 clinical study.
This US-based clinical study is a part of an international development plan, and dosing of the first group was completed a week before (this report was published) in Germany. Phase I/II clinical study is designed for establishing safety and immunogenicity along with an optimal dose of mRNA vaccine candidates.
Pfizer and BioNTech are working for increasing manufacturing for global supply, in expectation of a successful clinical development program.
Pfizer intends to initiate its massive manufacturing network, as well as invest at risk in an attempt to generate an approved COVID-19 vaccine promptly for meeting the demand across the globe.
Upon the regulatory authorization, both the companies will work combinedly for commercialization of vaccine across the world excluding China. In China, BNTX has collaborated with Fosun Pharma for clinical development as well as commercialization of BNT162.
On 27 May 2020, BNTX stock closed the trading session at $47.59, down by 6.47%.
- Heat Biologics
A biopharmaceutical company Heat Biologics is engaged in developing immunotherapies aimed to activate immune system of a patient against tumors and other diseases by employing its proprietary gp96 platform that activates CD8+ "Killer" T-cells. The Company has unveiled a program with the University of Miami (UM) for development of a vaccine to combat COVID-19.
The gp96 vaccine program for COVID-19 is focused on providing prophylactic safety to aged patients, and those having underlying health conditions, patients having increased risk of complications and fatalities from COVID-19 infection.
This vaccine is being designed to clear infected cells by stimulating enduring cellular immunity, that is important for preventing spread of re-infection in vulnerable group of patients such as the aged people and high-risk patients having other diseases.
In contrast to the regular vaccines that are primarily responsible for developing a humoral response, COVID-19 vaccine platform of Heat Biologics steer a major cellular immune response through CD8+ T cells, with a humoral immune response through a neutralising IgG (immunoglobulin G) antibody.
The gp96 vaccine platform of Heat biologics activates antigen presenting cells, CD8 T cells and NK cells, hence induce mucosal immunity which may possibly make it an ideal vaccine for COVID-19.
Expected milestones for the second quarter of 2020 include:
- Johnson & Johnson (NYSE:JNJ)
World’s largest and most broadly-based healthcare company Johnson & Johnson is engaged in the manufacturing of health care products and offers related services for the pharmaceutical, medical devices and diagnostics market as well as for consumers.
Johnson & Johnson disclosed on collaboration with Emergent BioSolutions for expanding its manufacturing capabilities for vaccine candidate for COVID-19 in favour of its aims to provide over 1 billion vaccine doses across the globe. JNJ revealed partnership with Emergent BioSolutions for aiding the production of its lead investigational COVID-19.
Emergent would reserve operations capability to possibly support commercial manufacturing of COVID-19 vaccine candidate of Johnson & Johnson leveraging AdVac® and PER.C6® technologies established by Janssen. The commercial production of JNJ’s vaccine candidate would commence in 2021.
JNJ has started making arrangements for clinical vaccine manufacturing at its facility in Netherlands itself, with the intention of starting human clinical trials Phase 1 of its vaccine candidate in September this year.
On 27 May 2020, stock of JNJ closed the market session at $144.89, up by 0.23%.
- CureVac AG
Clinical-stage biopharmaceutical company CureVac AG is engaged in developing an innovative class of transformative medicines centered on optimized mRNA. The Company uses its mRNA technologies for developing antibody therapies, cancer therapies, prophylactic vaccines as well as treatment of rare diseases.
During mid-May 2020, CureVac revealed that its optimized mRNA platform demonstrated positive outcome in pre-clinical study at a minimum dosage for COVID-19 vaccine candidate. The data revealed a quick stimulation of a steady immune response with increased levels of virus neutralizing titers as well as T-cell responses.
The Company anticipates beginning the first phase I/IIa clinical study with its lead vaccine candidate in healthy volunteers in June 2020.
CureVac has manufactured significant amounts of material for development of vaccine candidate in its Germany based GMP III manufacturing facility.
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