With over 4.6 million people infected by the coronavirus across the world, and more than 312k people dead, the necessity for a vaccine against COVID-19 becomes more urgent by the day. According to WHO, coronavirus might become an endemic virus and may never go away. There is no clear end that could be observed for this contagious viral disease as the numbers are increasing around the globe.
Now the question is, what is an endemic disease? Well, according to the US CDC (Centers for Disease Control and Prevention), the endemic disease is one which is always present among a significant population.
Global market sentiment and hopes were boosted by a promising vaccine trial against COVID-19 by US-based healthcare company Moderna, which lifted expectations for a faster recovery from the current global crisis.
ASX shares had soared in early trade as investors now believe a vaccine against COVID-19 could sooner than anticipated, particularly after the US-based drug manufacturer revealed that the early-stage clinical study for its vaccine showed promising results. On 19 May 2020, the benchmark S&P/ASX 200 index had lifted by 1.81% to 5,559.5 points.
Let us now delve deep and discuss what Moderna has announced recently:
Hope for a cure: Moderna’s Vaccine candidate Showed Positive Results in Phase 1 Study
Nasdaq-listed, US-based clinical-stage biotechnology company Moderna Inc (Nasdaq:MRNA) is a pioneer in manufacturing of mRNA (messenger RNA) therapeutics and vaccines for developing a new generation of transformative pharmaceuticals (medications, drug, vaccines) for patients.
The Company’s accelerated research and development for developing a vaccine (mRNA-1273) against SARS-CoV-2 are depicted in the below image:
Phase I Clinical Study Data showed Promise
The Company revealed optimistic interim clinical data of mRNA-1273, its vaccine candidate against the novel coronavirus (SARS-CoV-2), from the Phase I clinical study which is conducted by the NIAID (National Institute of Allergy and Infectious Diseases), as a part of the National Institutes of Health (NIH).
Based on the interim Phase I outcome, Phase II study for the vaccine would be modified to evaluate two dose levels, 50 µg and 100 µ and the purpose would be to choose one dose for pivotal clinical studies.
The Company disclosed that Phase I study is being modified for including 50 µg dose level cohort across three age groups, and Moderna anticipates the dose for the Phase III clinical study to be in between 25 and 100 µg. Moreover, the Company expects the Phase III clinical trial commencement in July and is subject to finalization of the clinical study protocol.
Furthermore, the Company disclosed that the funding from the Biomedical Advanced Research and Development Authority (BARDA) supported the planning and development for the Phase II and Phase III clinical studies of mRNA-1273 and would also support the execution of these studies.
The mRNA-1273 vaccine was found to be safe and well-tolerated, with a steady safety profile that was observed in prior clinical studies for infectious disease vaccine of Moderna.
The single incidence of a grade three adverse event in the 25 µg and 100 µg dose cohorts was observed in a single participant at a dose of 100 µg who experienced grade three erythema around the site of administration (injection).
So far, the most distinguished adverse events were observed at the dose level of 250 µg, encompassing 3-participants with grade three systemic indications, only after the second dose. Moderna disclosed that all adverse events during the study have been transient and self-healing.
It is noteworthy to mention that no grade four adverse events or serious adverse events have been reported during the study. Study Design and dosing regimen for Phase I clinical study:
The funding provided by BARDA would also help to increase manufacturing of mRNA-1273 both at the facilities of Moderna and its strategic collaborator, Lonza Ltd.
Brief about mRNA-1273
mRNA-1273 is an mRNA vaccine that is under clinical investigation against novel coronavirus encoding for a prefusion stabilized form of the Spike (S) protein, that was chosen by Moderna in partnership with investigators from NIAID’s Vaccine Research Center, a part of the NIH.
- On 6 May 2020, the US FDA completed its review of IND application by Moderna for mRNA-1273 permitting it to continue a Phase II clinical study, which is anticipated to commence soon.
- On 12 May 2020, mRNA-1273 fast track designation from the US FDA. The Company is finalizing the protocol for a Phase III clinical study, that is projected to start in July 2020.
Collaboration With Lonza to Develop mRNA-1273
Moderna and Lonza collaborate to enable manufacturing of up to 1 billion doses per year.
Both the companies intend to launch manufacturing suites at the United States and Switzerland facilities of Lonza. The transfer of technology is anticipated in June 2020 with the first batches of mRNA-1273 projected to be manufactured at Lonza NH in July 2020.
The Company has up to US$2.4 billion to invest and create value, and this includes-
- Cash Position- Approximately $1.72 billion of cash and investments as of 31 March 2020.
- Up to US$483 million for increasing development of mRNA-1273 against SARS-CoV-2 as novel coronavirus award from the US government agency BARDA.
- Additional grants of approximately US$180 million as total additional funding.
Late-stage development for the mRNA-1273 vaccine for SARS-CoV-2
The planned phase II clinical study of mRNA-1273 vaccine is anticipated to commence in the second quarter of 2020. The study is planned for two shots of mRNA-1273 given at twenty-eight days apart and would assess the safety, reactogenicity as well as immunogenicity. Notably, the Company is finalizing the protocol for Phase III clinical study that is projected to commence in early summer of 2020.
After the announcement of positive outcomes from clinical study against coronavirus, shares of Moderna rose by 13.31% to settle the day’s trade at US$80.00 on 18 May 2020.
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