John Cahill, Director, Senior Consultant, Quality & Compliance, PharmaLex Ireland, provides an update on the status of several COVID-19 vaccine and therapeutic development programmes, emphasising the considerable efforts being made by industry, regulatory agencies and others, to accelerate development in what is normally, due to the need for stringent regulation, a notoriously slow-moving sector.
For those of us in an industry who comprehend the lengthy and expensive process of drug discovery, testing and trials, the speed and urgency at which our industry is moving to develop an effective vaccine and treatment is something to be proud of.
As readers of this article who have most likely worked in the regulatory, research, development or manufacturing area for drug products, I’m sure you have been drawn to read the many scientific and technical advances that are being fast tracked at present in response to the current global emergency. For those of us in an industry who comprehend the lengthy and expensive process of drug discovery, testing and trials, the speed and urgency at which our industry is moving to develop an effective vaccine and treatment is something to be proud of. It is now understood by researchers, companies and regulators that while ensuring safety, efficacy and quality are still of critical importance…speed is now paramount!
Here are some examples of candidates that are being developed at breakneck speed:
- The drug Favilavi, which was the first approved coronavirus drug in China, has reportedly shown efficacy in treating COVID-19 safely in a clinical trial involving 70 patients.
- The first Covid-19 vaccine in China is expected to be ready for clinical trials by the end of April.
- Inovio Pharmaceuticals plans to begin human clinical trials on their coronavirus vaccine INO-4800 in April this year. 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 and/or emergency use of the vaccine.
- Regeneron have accelerated its timeline for having doses of a potential vaccine (REGN3048 and REGN3051) and treatment ready for human clinical trials by early Summer. Large scale manufacture could start by the middle of April.
- Gilead’s remdesivir (GS-5734) is an experimental broad spectrum anti-viral, originally designed to treat Ebola, has undergone clinical trials in China. The trials are being performed on 761 patients in a randomised, placebo-controlled, double-blind study at multiple hospitals in Wuhan. The results from the trials are expected to be available over the next few weeks.
- Moderna’s mRNA-1273 vaccine is undergoing a Phase I clinical study in April with support from the US National Institute of Health and are preparing for a Phase II study already. The vaccine targets the Spike (S) protein of the coronavirus.
- Roche’s Actemra has been approved in China for the treatment of severe complications related to coronavirus. Actemra is being evaluated in a clinical trial in China, which is expected to enrol 188 coronavirus patients. The clinical trial is expected to be conducted until May 10.
- Many clinical trials are underway with chloroquine for fighting COVID-19; this drug has been shown to be safe and efficacious against malaria for decades. Coronavirus patients administered with the chloroquine Phosphate drug achieved a better drop in fever and shorter recovery time in clinical trials being conducted in Chinese hospitals. Large scale clinical trials with this drug are imminent.
- An intranasal Covid-19 vaccine (similar to NasoVAX) is being developed by US-based clinical-stage biopharmaceutical company, Altimmune. Animal studies are being progressed.
Table 1 below summarises the many other candidates at different stages of the condensed drug development lifecycle.
|Company/Research||Drug/Vaccine Candidate||Development Stage|
|MIGAL||Infectious Bronchitis Virus (IBV) vaccine||Preclinical trials|
|APEIRON Biologics||APN01||Phase I|
|Tonix Pharmaceuticals||TNX-1800||Initial Evaluation|
|Innovation Pharmaceuticals||Brilacidin||Initial Evaluation|
|Clover Biopharmaceuticals||S-Trimer vaccine||Preclinical trials|
|CytoDyn||Leronlimab||Phase II for HIV and Fast tracked for COVID-19|
|Applied DNA Sciences and Takis Biotech||Linear DNA Vaccine||Preclinical trials|
|Novavax||MERS coronavirus vaccine||Phase I in 2020|
|Biocryst Pharma||Galidesivir||Advanced Animal Testing|
|Heat Biologics||gp96 vaccine||Early Development|
|Pfizer and BioNTech||mRNA vaccine, BNT162||Clinical programme development with Fosun in China|
|Generex||Ii-Key immune system activation||Clinical programme development in China|
|Vir Biotechnology/WuxiVir Biotechnology/Alnylam||MABs binding to virussiRNA candidates||TBC|
|Janssen Pharmaceuticals||PREZCOBIX® HIV medication (darunavir/cobicistat)||TBC|
Table 1. Selection of Drug Candidates for the Vaccination and treatment of COVID-19.
As evident above, drug discovery and clinical research activities in COVID-19 prevention and treatment is increasing in pace. It would not be surprising if a workable vaccine has already been discovered and is being tested at present. It will take some time to establish the complete safety and efficacy of the successful candidates but with the combined knowledge and urgency that now exists in R&D, we should have reason to be confident of a future without COVID-19. In the meantime, and unfortunately this may still be some months away, we must follow national health authority guidance, trust in science and stay safe for each other.
Source: PharmaLex Web Page.