COVID-19: Vaccine Development & Intelligence Update
As we are all well aware, developing new antiviral drug treatments is a long and arduous process. However, medicines already well progressed in the development pipeline, or even already treating diseases in patients, can be useful to fight COVID-19 — hopefully considerably shortening the time it will take to make an effective medicine to deal with the current crisis.
After closely tracking these clinical development efforts over the past week, the following is the latest intelligence on medicines against Coronavirus.
Moderna
The first dose of the mRNA-1273 coronavirus vaccine, developed by the US National Institutes of Health (NIH) and Moderna’s infectious disease research team, was given to the first participant in their Phase 1 study on March 16. The trial of the vaccine, built on previous studies of SARS and MERS, is intended to provide data on the safety and immunogenicity of the vaccine, and is expected to enrol 45 healthy adult volunteers over six weeks.
The Cambridge, Massachusetts-based drug discovery company emphasized that it is “still early in the story,” with no approved drugs to date emerging from its vaccine program and no previous human trials. The current trials are being carried out at the Kaiser Permanente Washington Health Research Institute in Seattle.
Dr. Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, described the study as “an important first step toward” finding a safe and effective vaccine.
CanSino Biologics
Authorities in China granted approval last week for Phase 1 clinical trials of a coronavirus vaccine developed by researchers at Tianjin-based CanSino Biologics and the Academy of Military Medical Sciences.
Tests of Ad5-nCoV in animals, researchers said, showed that the vaccine candidate can induce strong immune response and demonstrated a good safety profile. Pre-screening for the first human study has already begun, and is expected to enrol 108 healthy participants at Wuhan’s Tongji Hospital.
“Having committed to provide unconditional support to fight against the global epidemic, CanSinoBIO is determined to launch our vaccine product candidate as soon as possible with no compromise on quality and safety,” said CanSino chairman and CEO Xuefeng Yu.
MIGAL
Located in Kiryat Shmona, the MIGAL — Galilee Research Institute is working to adapt a vaccine initially developed to prevent the Infectious Bronchitis Virus (IBV) in poultry.
Funded by the government, the institute hailed a “scientific breakthrough that will lead to the rapid creation of a vaccine against coronavirus” in late February, based on the genetic similarity between the avian coronavirus and the novel coronavirus. Human testing of the oral vaccine, the institute said, is expected to begin within eight to 10 weeks, and safety approval is expected within 90 days.
“We are currently in intensive discussions with potential partners that can help accelerate the in-human trials phase and expedite the completion of final product development and regulatory activities,” said MIGAL CEO David Zigdon.
INOVIO Pharmaceuticals
Pennsylvania-based INOVIO announced the receipt of a new $5 million grant from the Bill & Melinda Gates Foundation on March 12 to accelerate the testing of its novel DNA vaccine for COVID-19, known as INO-4800.
Currently in preclinical studies, INOVIO plans to advance into US Phase 1 clinical trials next month, backed by up to $9m. In funding from the Coalition for Epidemic Preparedness Innovations. The company says it aims to deliver one million doses of INO-4900 and handheld intradermal delivery devices to administer them by the end of 2020.
“Our team of vaccine experts are working around the clock to advance INO-4800 and we look forward to attracting additional partnerships to expedite its development to meet this urgent global health need,” said INOVIO president and CEO Dr. J. Joseph Kim.
CureVac
Reportedly the target of an acquisition attempt by US President Donald Trump, German biopharmaceutical company CureVac announced that it is leveraging its mRNA-based drug platform to produce a vaccine against the novel coronavirus.
The European Commission has offered up to €80 million of financial support to CureVac, which plans to launch clinical tests in June 2020. If proven, the commission said, millions of vaccine doses could be produced at low costs in the company’s existing production facilities.
“The combination of mRNA science, disease understanding, formulation and production expertise make CureVac a unique player to fight against any infectious disease, no matter whether they are seasonal or pandemic,” said CureVac CTO Mariola Fotin-Mleczek.
BioNTech
German immunotherapy Company BioNTech and American pharma giant Pfizer signed a letter of intent last week to co-develop and distribute an mRNA-based vaccine against the novel coronavirus. The partnership, originally formed in 2018 to develop flu vaccines, will accelerate BioNTech’s COVID-19 vaccine program BNT162, which is expected to enter the clinic by the end of April.
Just one day earlier, the Mainz-based company announced a strategic development and commercialization collaboration with Fosun Pharma to advance its mRNA vaccine in China. Fosun Pharma will pay BioNTech up to $135m in upfront and potential future investment and milestone payments.
“We feel a duty to exploit our full technology and immunotherapy expertise to help address the COVID-19 pandemic emergency,” said BioNTech founder and CEO Prof. Ugur Sahin, adding that the company is also working on a novel therapeutics approach for patients who have already been infected. Details, he said, will be disclosed “in the coming weeks.”
Note from the Author
ClinTex are a solution provider for the pharmaceutical industry and team behind CTi -Clinical Trials Intelligence, a blockchain enterprise solution designed to bring down the cost of medicine, as well as increase the speed of access to new medicine, for the people that need it.
Driven by the COVID-19 pandemic, collaborative efforts are ongoing to share clinical intelligence on antiviral medications. But why does it take a pandemic to drive this collaboration — should this not be the future norm for medicines development?
We believe in the future, the sort of invaluable work being done right now in relation to COVID-19 will be coordinated across the industry, as standard, through the intelligent sharing of data via platforms such as CTi.
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