Therapy Areas: Inflammatory Diseases
Moderna Receives Funding Award from CEPI to Accelerate Development of Messenger RNA Vaccine Against Novel Coronavirus
27 January 2020 - - US-based clinical stage biotechnology company Moderna, Inc., (NASDAQ: MRNA) has forged a new collaboration to develop an mRNA vaccine against the novel coronavirus (2019-nCoV), the company said.

Under the terms of the agreement, Moderna will manufacture an mRNA vaccine against 2019-nCoV, which will be funded by CEPI.

The Vaccine Research Center of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, collaborated with Moderna to design the vaccine. NIAID will conduct IND-enabling studies and a Phase 1 clinical study in the US.

Over the past four years Moderna has had six positive Phase 1 clinical readouts in its prophylactic vaccines modality and moved two additional programs into development.

Moderna's technology platform, fully integrated manufacturing site and development experience, combined with a multi-year relationship with the NIH, including exploring ways to respond to public health threats, allows for the rapid identification and advancement of a vaccine candidate against 2019-nCoV.

Coronaviruses are a family of viruses that can lead to respiratory illness, including Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV).

Coronaviruses are transmitted between animals and people and can evolve into strains not previously identified in humans.

On January 7, 2020, a novel coronavirus (2019-nCoV) was identified as the cause of pneumonia cases in Wuhan City, Hubei Province of China, and additional cases have been found in a growing number of countries.

Moderna scientists designed the company's prophylactic vaccines modality to prevent or control infectious diseases. This modality now includes five programs, all of which are vaccines against viruses.

More than 1,000 participants have been enrolled in Moderna's infectious disease vaccine clinical studies under health authorities in the US, Europe and Australia.

The potential advantages of an mRNA approach to prophylactic vaccines include the ability to mimic natural infection to stimulate a more potent immune response, combining 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 currently has five development candidates for potential commercial uses in this modality, including: respiratory syncytial virus vaccine (mRNA-1777 and mRNA-1172 or V172 with Merck), cytomegalovirus vaccine (mRNA-1647), human metapneumovirus and parainfluenza virus type 3 (hMPV/PIV3) vaccine (mRNA-1653) and Zika vaccine (mRNA-1893) with the Biomedical Advanced Research and Development Authority (BARDA).

Three development candidates in this modality are available for potential global health uses including: influenza H10N8 vaccine (mRNA-1440), influenza H7N9 vaccine (mRNA-1851) and chikungunya vaccine (mRNA-1388), which was developed with the Defense Advanced Research Projects Agency (DARPA).

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

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

The company has built a fully integrated, highly digitalised manufacturing plant in Norwood, MA which enables the promise of the technology platform.

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 have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases.

The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the company the capability to pursue in parallel a robust pipeline of new development candidates.

Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. (NASDAQ: AZN) and Merck, Inc. (NASDAQ: MRK), as well as the Defense Advanced Research Projects Agency (NASDAQ: DARPA), an agency of the US Department of Defense and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant secretary for Preparedness and Response within the US Department of Health and Human Services. Moderna has been named a top biopharmaceutical employer by Science for the past five years.
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