24 August 2020 - - US-based biotechnology company Moderna, Inc. (NASDAQ: MRNA) has concluded advanced exploratory talks with the European Commission to supply 80m doses of mRNA-1273, Moderna's vaccine candidate against COVID-19, as part of the European Commission's goal to secure early access to safe and effective COVID-19 vaccines for Europe, the company said.

The potential purchase agreement with the European Commission of 80 m doses provides for an option for Member States to purchase an additional 80 m doses for a total of up to 160m doses. The discussions are intended to ensure that Member States have access to Moderna's vaccine.

The Phase 3 study of mRNA-1273 began on July 27 and enrollment of approximately 30,000 participants is on track to complete in September.

Moderna is scaling up global manufacturing to be able to deliver approximately 500 m doses per year and possibly up to 1 bn doses per year, beginning in 2021.

In Europe, the company is working with its strategic manufacturing partners, Lonza of Switzerland and ROVI of Spain, for manufacturing and fill-finish outside of the United States.

This is a dedicated supply chain to support Europe and countries other than the United States that enter into purchase agreements with Moderna.

Over the past nine years, Moderna has invested in creating and developing a novel platform for designing and manufacturing a new class of mRNA-based vaccines.

The investments in this proprietary platform have enabled Moderna to expeditiously create, manufacture and clinically develop mRNA-1273 to potentially address the current COVID-19 pandemic. A summary of the company's work to date on COVID-19 can be found here.

mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Disease's (NIAID) Vaccine Research Center.

The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the National Institutes of Health on February 24, 42 days from sequence selection.

The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing.

On May 12, the FDA granted mRNA-1273 Fast Track designation. On May 29, the first participants in each age cohort: healthy adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of mRNA-1273. On July 8, the Phase 2 study completed enrolment.

The Phase 3 COVE study of mRNA-1273, being conducted in collaboration with the NIH and the Biomedical Advanced Research and Development Authority (BARDA), began on July 27; enrollment is on track to complete in September.

Results from a non-human primate preclinical viral challenge study evaluating mRNA-1273 were recently published in The New England Journal of Medicine. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of mRNA-1273 was published in The New England Journal of Medicine.

Moderna scientists designed the company's prophylactic vaccines modality to prevent infectious diseases.

More than 1,900 participants, prior to enrolling the Phase 3 study of mRNA-1273, have been enrolled in Moderna's infectious disease vaccine clinical studies under health authorities in the US, Europe and Australia.

Clinical data demonstrate that Moderna's proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens.

Based on clinical experience across Phase 1 studies, the company designated prophylactic vaccines a core modality and is working to accelerate the development of its vaccine pipeline.

The potential advantages of an mRNA approach to prophylactic vaccines include the ability to combine multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats and manufacturing agility derived from the platform nature of mRNA vaccine design and production.

Moderna has built a fully integrated manufacturing plant which enables the promise of the technology platform.

To date, Moderna has demonstrated positive Phase 1 data readouts for eight prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3, CMV, Zika and COVID-19).

Moderna's CMV vaccine is currently in a Phase 2 dose-confirmation study. Moderna's investigational Zika vaccine (mRNA-1893), currently in a Phase 1 study, was granted FDA Fast Track designation in August 2019.

Moderna is advancing messenger RNA science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases.