AUS
NZ
UK
CA
USA
IND
Summary
- Clinical-stage biotechnology company Moderna commenced Phase 3 COVE study for its COVID-19 vaccine, mRNA-1273.
- Moderna stock has delivered an exceptional return of approximately 484% in the last one year and an outstanding return of ~257% in the previous six months.
- The Company remains on track to provide nearly 500 million doses every year, and possibly up to 1 billion doses per year, starting in the year 2021.
- Moderna announced a modification to its contract with BARDA for an additional commitment of up to US$472 million for late-stage clinical development.
The situation of global health emergency created by SARS-CoV-2, the virus responsible for COVID-19 pandemic, is worsening each day. The coronavirus has infected over 16.11 million people across the world and left 646,641 individuals dead (WHO data as at 7:24 PM CEST on 27 July 2020).
Scientists from every corner of the world are engaged in finding a suitable vaccine/treatment to combat COVID-19, and there are several vaccines and drugs under clinical and pre-clinical investigation.
According to the latest landscape report (27 July 2020), provided by the World Health Organization (WHO), there are 25 vaccine candidates under clinical development, and a further 139 under pre-clinical evaluation. Out of 25 vaccine candidates, four are in late-stage clinical studies with Moderna’s mRNA-1273 being one of them.
TO KNOW MORE, DO READ: Your Complete Guide: Companies Hitting the COVID-19 Vaccine Charter
The Cambridge, Massachusetts-headquartered Company is working progressively and is on track to develop its vaccine candidate, mRNA-1273 against COVID-19. Let us look at the Moderna’s recent announcement.
Moderna Commences Phase 3 COVE Study of COVID-19 Vaccine mRNA-1273
On 27 July 2020, clinical-stage biotechnology company Moderna Inc(Nasdaq:MRNA) announced that the Phase 3 clinical trial of its mRNA COVID-19 vaccine candidate, mRNA-1273 commenced dosing participants. The Phase 3 clinical trial, named as the COVE study (Coronavirus efficacy study), is being conducted in partnership with the NIAID, part of the National Institutes of Health (NIH), and BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.
The Phase 3 clinical trial protocol follows the guidance provided by the US FDA on clinical trial design for vaccine studies to combat COVID-19.
The US markets cheered the important news with the stock of Moderna Inc climbing 9.15% to close the day’s trade at US$79.91 on 27 July 2020. In the last one year, the stock has delivered an exceptional return of 483.71%, and an outstanding return of 257.38% in the previous six months.
Phase 3 clinical trial: a randomized, placebo-controlled study
The Phase 3 clinical trial is randomized, placebo-controlled, and is anticipated to include nearly 30k participants in the US. The dose of mRNA-1273 for the trial would be 100 µg.
The primary endpoint of the study will be the prevention of symptomatic COVID-19. The key secondary endpoints comprise prevention of severe COVID-19 (as defined by the necessity for hospitalization) and the prevention of infection by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), irrespective of symptomology.
The primary efficacy analysis of the clinical trial would be an event-driven analysis based on the participants with symptomatic COVID-19.
To make sure the undergoing safety monitoring of the participants in the clinical study, the information will be examined by an independent Data and Safety Monitoring Board organized by NIAID during the study.
With its partners, the Company has selected approximately 100 clinical research sites with representative demography. Moderna is partnering closely with these sites to make sure that volunteers at higher risk for COVID-19 disease are enrolled in the clinical study.
It is noteworthy to mention that Moderna remains on the right track to provide almost 500 million doses each year, and possibly up to 1 billion doses per year, beginning in the year 2021 because of its internal US manufacturing capabilities as well as a strategic partnership with Lonza Ltd.
Addition to this, Moderna is also working in partnership with long-standing partner PPD (Nasdaq:PPD), a leading global CRO offering comprehensive, integrated drug development, laboratory, as well as lifecycle management services.
PPD backed the Phase 2 clinical trial of Moderna’s COVID-19 vaccine program, which completed the enrollment of 600 subjects at eight research sites within a month.
GOOD READ: Global Vaccine Developers Providing Excellent Returns
Expansion of BARDA Agreement to Support Larger Phase 3 Program of mRNA-1273
On 26 July 2020, Moderna revealed a modification to its contract with the BARDA for an additional commitment of up to US$472 million to back its late-stage clinical development including the expansion of Phase 3 clinical trial for mRNA vaccine candidate (mRNA-1273) against COVID-19.
An earlier award from BARDA for up to US$483 million was announced to provide support for scaling up of mRNA-1273 and clinical development, initially with a smaller expected number of subjects in Phase 3 clinical study.
Post the discussions with the US FDA and consultations with Operation Warp Speed (OWS) over the past few months, Moderna has agreed to conduct a considerably large Phase 3 clinical trial, leaving a gap in BARDA funding that will be closed by this modification in the contract. With the revised contract, BARDA is increasing their support for the late-stage clinical development of mRNA-1273, as well as the execution of 30k subjects in Phase 3 clinical trial in the US. Now, the total value of the award is almost US$955 million.
The biotech player is working closely with Operation Warp Speed (OWS) and the NIH, including COVID-19 Prevention Trials Network (CoVPN) of NIAID, for conducting the Phase 3 COVE trial.
With the continuous progress Moderna is making in the clinical development of its COVID-19 vaccine, mRNA-1273, hopes of millions rest on the Company’s shoulders. With the recent update, we are one step closer to getting the vaccine to combat the deadly COVID-19.
