On January 7, 2020, a novel coronavirus (2019-nCoV) was identified in humans in Wuhan City, Hubei Province, China. Additional cases have been found in the United States and in a growing number of countries around the world.
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.
The symptoms of coronavirus infections extend from mild to moderate, to severe, including the aforementioned syndromes and pneumonia. Deaths of contaminated patients with this virus have occurred in the past. The big problem is the lack of vaccines against this virus, let alone against the novel 2019-nCoV strain discovered recently.
That’s why the news about the new infection is highly disturbing around the world. The bad news is said to be behind today’s tumbling of the stock market, at least during the early hours of the day.
One of the rare stocks that outperformed in the biotech sector today, instead of plummeting, is that belonging to Moderna (MRNA).
Solving the Problem
What is really needed to solve the viral epidemic problems is an approach that can rapidly make available prophylactic and treating vaccines against unexpected severe viral epidemics.
Moderna announced a new collaboration agreement with health authorities aimed at developing an mRNA vaccine against the novel coronavirus (2019-nCoV). Under the terms of the agreement, Moderna will manufacture an mRNA vaccine against 2019-nCoV, which will be funded by the Coalition for Epidemic Preparedness Innovations (CEPI). The Vaccine Research Center (VRC) 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 U.S.
Over the past four years, Moderna has had six positive Phase 1 clinical readout in its prophylactic vaccines modality and has 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, which includes exploring ways to respond to public health threats, allows for the rapid identification and advancement of a vaccine candidate against 2019-nCoV.
Comments from the Experts
Richard Hatchett, M.D., CEO of CEPI, said, “Moderna’s commitment to global public health is aligned with CEPI’s vision of creating a world in which epidemics are no longer a threat to humanity. We are pleased with the pace of our combined response to the emerging threat of the novel coronavirus. Through our partnership with Moderna and the NIH, we hope to speed the development of a vaccine against the coronavirus and help to alleviate the burden of disease.”
Stéphane Bancel, CEO of Moderna, said about its capability and role to play in the fast creation of the vaccine, “We believe our mRNA vaccine technology offers potential advantages in the speed of development and production scalability, which positions Moderna to potentially develop a vaccine against coronavirus, 2019-nCoV.
Advances in global public health require the collective effort of public-private partnerships – no organization can act alone. We are honored to be supporting NIH and CEPI in their mission to identify a potential vaccine to prevent infection. It is impressive that CEPI was able to commit to this grant in a matter of days. We are thankful for the financial support from CEPI and the multi-year scientific collaboration we have with the NIH.”
Moderna: Five Anti-viral Vaccine Programs
In the firm’s press release we read that Moderna’s scientists have 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 U.S., 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 (RSV) vaccine (mRNA-1777 and mRNA-1172 or V172 with Merck),
- cytomegalovirus (CMV) 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); developed with the Defense Advanced Research Projects Agency(DARPA).
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 Phase 2 dose-selection study.
Moderna’s investigational Zika vaccine (mRNA-1893), currently in a Phase 1 study was granted FDA Fast Track designation.
Moderna has built a fully integrated, highly digitalized manufacturing plant in Norwood, MA; enabling the promise of the technology platform.
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients.
mRNA therapies direct the body’s cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit.
Moderna’s platform builds on continuous advances in basic and applied mRNA science.
Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, alone and with strategic collaborators.
Other Institutions: The Defense Advanced Research Projects Agency (DARPA), the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S, and the Department of Health and Human Services (HHS).
Moderna’s approach, history, capability and pipeline of investigational viral vaccines, as well as all the above, indicates that the firm is ready, willing and able to create a prophylactic viral vaccine in record time. Confirming this opinion is the readiness of the Government health institutions, and other health institutions, to go hand in hand with Moderna to contribute to the realization of the prophylactic vaccine.
The stock ended the day trading at $22.74, UP $1.62; while the Dow is down over $400 and the Nasdaq is down over $130. After hours the stock climbed another $0.66 finishing the day at $23.40
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