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Three Promising Vaccines with Potential to Combat COVID-19

02 Dec Three Promising Vaccines with Potential to Combat COVID-19

According to the World Health Organization (WHO), Coronavirus (CoV) is a family of viruses that cause illnesses ranging from common cold to lethal diseases such as the Middle East Respiratory Syndrome (MERS-CoV), Severe Acute Respiratory Syndrome (SARS-CoV) and a new strain of CoV named, novel coronavirus (nCoV). The virus is Zoonotic as it is transmitted from animals to humans, with the presence of many strains that have not yet infected humans. The infection manifests in the form of respiratory symptoms, cough, fever, shortness of breath and can take the form of pneumonia, severe acute respiratory syndrome, kidney failure and even death.

WHO had identified a new type of coronavirus, namely 2019 novel coronavirus (2019-nCoV) in China in early January 2020, which has so far infected 62,844,837, including 1,465,144 deaths according to the WHO Coronavirus dashboard. The disease which originated from the Chinese city of Wuhan, has spread to 168 countries, areas and territories. According to the US Centers for Disease Control and Prevention (CDC), there are 13,447,627 known cases across 39 states and 267,302 people have died so far in the U.S alone (as of December 2, 2020).

There is no definite cure for treatment or eradication of CoV, with treatment being limited to alleviation of symptoms, and providing support and care to patients. Scientists have been able to sequence the virus genetic code; spurring organizations around the world into action.

Operation Warp Speed is one such initiative that aims to provide 300 million doses of safe and effective vaccines and diagnostics. The initiative, which is essentially a partnership between Department of Health and Human Services (HHS) including Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense (DoD), will work with private firms and several federal agencies. The initiative has received over $ 10 billion in funding through the CARES Act and includes $6.5 billion designated for countermeasure development through BARDA and $3 billion for NIH research.

Moderna, Inc. (NASDAQ: MRNA

Market Cap: $55.80B; Current Share Price: 137.00 USDChart
Data by YCharts

Moderna is developing an mRNA vaccine for the treatment of the novel coronavirus (2019-nCoV), in collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI) and the National Institutes of Health (NIH). The Company uses its proprietary mRNA platform to discover and create novel solutions across indications such as prophylactic vaccine development, personalized cancer vaccine, intra-tumoral immune-oncology and localized regenerative medicine to name a few.

The Company has developed a unique mRNA sequence that codes for a protein, and encompasses knowledge of mRNA biology, chemistry, formulation & delivery, bioinformatics and protein engineering to address unmet needs in critical areas.

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The Platform offers great flexibility and wide applicability; by changing the sequence of the genetic code it can combine different mRNA sequences for different proteins in a single mRNA medicine. It has a drug design studio, which can develop mRNA within a very short period of time, using a proprietary Sequence Designer module, bioinformatics algorithms and its modular synthesis robotics, making it a pioneering Digital Biotech Company™.

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Moderna is working in Collaboration with the National Institute of Health’s Vaccine Research Center (VRC), a part of the National Institute of Allergy and Infectious Diseases (NIAID) to design the vaccine. Moderna has reported a 94.1 percent efficacy with no severe safety concerns and a 100 percent success rate in preventing severe COVID-19. mRNA-1273, its lead candidate, met its primary clinical endpoint in a phase III COVE trial. The company is gearing up to ship nearly 20 million doses, which can help over 10 million people, by working closely with the government designated drug distributor McKesson Corp and the Operation Warp Speed program.

In addition, the Company has rolling submissions ongoing in Canada and United Kingdom, besides receiving a confirmation of eligibility in the EU. The Company has partnered with Takeda in Japan and has an order of 50 million doses.

Unlike its closest competitor Pfizer-BioNTech, Moderna’s vaccine is likely to be easier to distribute as it does not require extremely cold temperature for storage. The Company is also planning to start a new trial in adolescents by December 2020, followed by another trail in an even younger test group by 2021. It is poised to manufacture 500 million to 1 billion doses globally in 2021 as per the company.

The potential of its drug candidate and positive outcome from its trials have helped the company’s market capitalization skyrocket from approximately $7B USD in January 2020 to $55B USD in December 2020. The share price has followed a similar trajectory, accelerating from around $20 in January 2020 to a record $141 levels in December 2020.

The Company has built a robust and diverse network of strategic collaborations with pharmaceutical and biotechnology organisation, in addition to government entities and research organisations to leverage its mRNA platform for drug discovery and development. Some of its collaborations are with Astra Zeneca, Merck, Vertex, BARDA, DARPA and Bill and Melinda gates foundation.

Novavax Inc (NASDAQ: NVAX

Market Cap: $7.86B; Current Share Price: 121.45 USDChart
Data by YCharts

Novavax, Inc has been granted a Fast Track Designation by the U.S Food and Drug Administration (FDA) for its lead COVID-19 vaccine candidate NVX-CoV2373. The candidate is undergoing late-stage clinical trials currently and has been created using its proprietary “recombinant nanoparticle” technology along with its Matrix-M adjuvant. The Company intends to launch crucial Phase 3 clinical trial in the United States and Mexico in the near future. In the United Kingdom, the trail has achieved a full enrolment of 15,000-participants, the results from which are expected to be available by Q1, 2021.

The Company is working on a vaccine for the deadly virus by leveraging its experience in developing candidates that offer protection against Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). Novavax has extensive experience of working with Coronaviruses, including preclinical work that encompasses severe acute respiratory syndrome coronavirus. The Company will be using the genetic sequence of the new coronavirus to develop its vaccine candidate. The technology used for the development of the potential vaccine has already been validated in its lead clinical program, namely Resvax, an RSV vaccine and a phase III Nanoflu vaccine.

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The Company was recently granted Fast Track Designation for NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate, adjuvanted with Matrix-M™, in adults 65 years of age and older by the U.S. Food and Drug Administration (FDA). The candidate is currently being evaluated in a pivotal phase 3 clinical trials to study its immunogenicity and safety compared to the quadrivalent formulation of Fluzone. The results from the study are expected to be announced by the end of Q3, 2020 and will act as the basis for its U.S. biologics license application (BLA) and future licensure of NanoFlu using the FDA’s accelerated approval pathway.

Novovax has a flu vaccine candidate named NanoFlu in phase 3 clinical trials and has formed a team to accelerate regulatory approvals in key markets and to evaluate the potential for using NanoFlu in conjunction with NVX-CoV2373, creating a combination flu/COVID-19 vaccine option in case the COVID-19 becomes a seasonal occurrence. The Company has already entered into agreements with countries such as U.S., Canada, U.K., and Australia for making available nearly 276 million doses of NVX-CoV2373.

The market capitalization of the company which was approximately $225M in January 2020 has skyrocketed to nearly $7B in December 2020. Similarly its stock price which was at 7.00 USD in January 2020 is now at approximately 123 USD, achieving a whopping 3000 percent growth this year.

In addition, its pipeline consists of ResVax, a respiratory syncytial virus fusion (F) protein nanoparticle vaccine candidate (RSV F Vaccine), an Ebola GP vaccine and a combination influenza / RSV F Vaccine for older adults.

BioNTech SE (NASDAQ: BNTX)

Market Cap: $28.17B; Current Share Price: 119.00 USDChart
Data by YCharts

BioNTech, a company focussed on creating individualized cancer medicine using cutting-edge research and technology, is collaborating with Pfizer and Fosun Pharma to create a potential vaccine for COVID-19 infections by leveraging its proprietary mRNA technology. The Company has launched a global development program, namely Lightspeed that builds on its expertise in mRNA platforms for infectious diseases, besides utilising its world-class GMP manufacturing infrastructure and global clinical development capabilities.

The vaccine received an approval in Britain and will be made available across the United Kingdom from next week, making it a historic moment in the fight against COVID-19.

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BioNTech’s approach to the COVID-19 vaccine is based on messenger RNA that can instruct human cells to make target protein or immunogen, to launch an immune response to generate protective antibodies. The main differentiating factor however, is that mRNA vaccines pose no risk of infection as they do not contain the virus, basically relying on immune response to fight against SARS-CoV-2.

The Company, in collaboration with Pfizer, announced the evaluation of BNT162b2, a nucleoside-modified messenger RNA (modRNA) candidate in global Phase 2/3 Studies across 120 clinical investigational sites worldwide, including the United States, Argentina, Brazil, and Germany. The candidate has received a fast track designation from the FDA based on preliminary data from phase 1/2 studies. 

The companies have submitted an Application for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) for BNT162b2, based on data from Phase 3 clinical study, which demonstrated a vaccine efficacy rate of 95% (p<0.0001). They have already submitted a request for Emergency Use Authorization (EUA) to the FDA based on the above clinical trial results and are expecting an approval by the end of December 2020 or even earlier.

In addition, BioNTech is working with Fosun Pharma in China and will jointly conduct clinical trials of BNT162 in China, which are currently being evaluated in a phase 2 clinical trial.

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BioNtech has an extensive pipeline of candidates focussed on diverse areas such as Advanced Melanoma (Adjuvant and Metastatic), Prostate Cancer, HPV16+ Head and Neck Cancer, Ovarian Cancer, Triple Negative Breast Cancer to name a few. It enjoys multiple strategic collaborations with companies such as Regeneron, Genentech, Genmab and Sanofi, besides preclinical collaborations with Bill and Melinda Gates Foundation, Genevant, Pfizer and the University of Pennyslavania.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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Reference

https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-submitted-application-conditional-marketing

https://investors.biontech.de/static-files/0f32a5a7-0990-4760-bd8c-a23816cd82d6

https://www.livemint.com/news/world/moderna-to-seek-us-eu-emergency-authorization-today-11606737892228.html

https://investors.modernatx.com/static-files/dc121fec-63eb-4794-a2fd-e0d3eadbaa6f

https://www.novavax.com/sites/default/files/2020.12.01_Novavax_Corporate_Investor_Presentation.pdf

https://www.modernatx.com/mrna-technology/mrna-platform-enabling-drug-discovery-development

https://www.thehindu.com/news/international/uk-approves-pfizer-biontech-covid-19-vaccine-for-use/article33228634.ece

https://covid19.who.int/?gclid=Cj0KCQiAk53-BRD0ARIsAJuNhpsYeTPYx0zeDfr-tKPst4wF_YlIfj_jQiikT04FtPTGAGetawiymPUaAiB6EALw_wcB

https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html

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