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news.Biopharmaceutical firm Medicago has commenced the phase I clinical trials with its plant-derived Covid-19 vaccine candidate.
Vial of a vaccine candidate. (Credit: Business Wire)
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The company, which has administered the first doses in healthy human volunteers, is also planning to initiate a phase 2/3 study this October.
The phase I clinical trial is a randomised and partially blinded study of 180 normal healthy subjects, male and female aged between 18 and 55 years.
Medicago’s will assess dosages of 3.75, 7.5, or 15 micrograms of the recombinant Coronavirus Virus-Like Particle (CoVLP) vaccine candidate alone or with an adjuvant in a prime-boost regimen.
The company will be evaluating its vaccine candidate with two adjuvants separately, including GSK’s pandemic adjuvant technology and Dynavax’s CpG 1018.
Medicago is planning to manufacture around100 million doses by the end of 2021. The construction of Medicago’s large-scale facility in the Quebec City of Canada will be completed by the end of 2023.
The commercial facility is expected to have the capacity to manufacture up to one billion doses of the Covid-19 vaccine per annum.
Medicago is claimed to be the only company with plant-based manufacturing technology, which has completed phase III clinical trials and pandemic phase II clinical trials.
Health Canada is currently evaluating the company’s first new drug submission for its seasonal recombinant quadrivalent VLP vaccine following the completion of a safety and efficacy clinical programme in more than 25,000 subjects.
Medicago president and CEO Dr Bruce Clark said: “Creating a sufficient supply of Covid-19 vaccines within the next year is a challenge which will require multiple approaches, with different technologies.
“Our proven plant-based technology is capable of contributing to the collective solution to this public health emergency.”
Earlier this month, Ridgeback Biotherapeutics commenced enrolment for the phase 2 trial of its Covid-19 drug candidate EIDD-2801, an orally-bioavailable form of a potent ribonucleoside analog.
