Global Vaccine Developers Providing Excellent Returns: A lens on Novavax, INOVIO Pharmaceuticals, Moderna, BioNTech – Kalkine Media

• Biotech and healthcare companies which are engaged in developing vaccine or treatment for COVID-19 are gaining attention by generating excellent returns for their shareholders.
• Novavax obtained funds worth US$1.6 billion from ‘Operation Warp Speed’ to support late-stage clinical development of its COVID-19 vaccine; the stock has jumped a massive 465% in the last three months.
• INOVIO Pharma reported promising initial data from the Phase 1 trial of INO-4800; the stock has delivered an outstanding return of 187% in the previous three months.
• Moderna completes manufacturing of vaccine required to commence the Phase 3 study: stock up an impressive 104%.
• BioNTech and Pfizer revealed initial positive data from an ongoing Phase 1/2 study of COVID-19 vaccine candidate BNT162b1.

According to WHO, globally, there have been more than 12 million confirmed cases of COVID-19, including 549,247 deaths (as of 8:14 AM CEST, 10 July 2020). The race to find a suitable (safe and effective) vaccine is gaining momentum. From around the corner, several names are emerging every day that announce their focus on developing a COVID-19 vaccine.
According to the draft landscape provided by the World Health Organization (WHO), there are a total of 160 vaccine candidates in different stages of clinical and pre-clinical development with varied technologies.
COVID-19 has altered the dynamics of the healthcare sector by creating several opportunities for the industry. Meanwhile, healthcare companies which are in the development of a vaccine or treatment to combat COVID-19, are gaining investors’ attention, and are generating considerable returns.
HAVE YOU READ:COVID-19 Vaccine Development: Where Do We Stand?
In this article, we will talk about four healthcare companies engaged in the development of COVID-19 vaccine and have delivered impressive returns in the past few months.
Let us delve deep and discuss the four players – NVAX, INO, MRNA, BNTX.
Novavax Receives US$1.6 Billion from ‘Operation Warp Speed’ to fund COVID-19 Vaccine
Late-stage biotechnology company Novavax Inc (NASDAQ:NVAX) is into the development of COVID-19 vaccine candidate called NVX-CoV2373. The vaccine comprises a stable, prefusion protein produced by using proprietary nanoparticle technology of Novavax and includes the proprietary Matrix?M™ adjuvant.
In May-end 2020, Novavax initiated a Phase 1/2 clinical trial of NVX-CoV2373 and notified that initial safety and immunogenicity data from the Phase 1 segment is anticipated in July 2020.  
On 7 July 2020, Novavax announced that the Company had been nominated to join Operation Warp Speed (OWS), a program launched by the US government intending to start delivering millions of doses of an effective and safe COVID-19 vaccine in 2021.
The Company has been awarded $1.6 billion by the US federal government (depending on the success in clinical trials) to complete late-stage clinical development, including:

• A pivotal Phase 3 clinical trial.
• Establishing large-scale manufacturing.
• Delivery of nearly 100 million NVX?CoV2373 doses, as early as late 2020.

Mr Erck added that Novavax is grateful to the US government for its confidence in the technology platform of the Company, and it is working vigorously for developing a vaccine for the ongoing global health crisis.
Under the deal terms, NVAX will show it can speedily stand up large-scale manufacturing and transition into undergoing production, with the potential to distribute significant quantities of NVX-CoV2373 once required.
The agreement with the government of the US will fund the late-stage clinical trials necessary for the determination of safety as well as the efficacy of NVX-CoV2373, and the pivotal Phase 3 clinical study with nearly 30k participants commencing in the fall of 2020.
The ongoing development of a COVID-19 vaccine has turned the tide for the US-based Company. From having to downsize as there was no approved vaccine and limited cash, to see its stock price break the roof, Novavax has seen an unprecedented change in its fortunes so far in 2020. 
INOVIO Pharmaceuticals Reported Promising Preliminary Data From Phase 1 clinical trial of its COVID-19 Vaccine
INOVIO Pharmaceuticals Inc (NASDAQ:INO) is engaged in the development of a DNA-based COVID-19 vaccine, called INO-4800.
On 30 June 2020, the Company disclosed favourable initial data from its Phase 1 clinical study with approximately 94% of the subjects demonstrating immune responses at week six, after two doses of INO-4800.
The vaccine candidate was found to be safe and well-tolerated with no serious adverse reactions. Moreover, INOVIO Pharma notified that the Company intends to commence Phase 2/3 efficacy clinical trial during the summer, subject to regulatory authorization.
The Company’s impressive Phase I data, coupled with its selection for the OWS program, has seen the stock jump enormously in the first half of 2020.
Moderna Completes Enrollment of Phase 2 Clinical trial of mRNA-1273
Clinical stage biotechnology company Moderna Inc (NASDAQ:MRNA) was the first to begin a human clinical study of a potential vaccine against COVID-19 in March 2020. The biotech player pleased its investors after revealing encouraging results from the Phase 1 clinical trial and then swiftly moving on to Phase 2. The Company also assured to commence Phase 3 clinical trials in July 2020.
On 8 July 2020, the Company revealed that it had completed enrollment for both cohorts of Phase 2 clinical trial of its COVID-19 vaccine candidate: mRNA-1273.
Moreover, the Company disclosed that cohorts of older adults (ages 56-70, n=30) and elderly adults (ages 71 and above, n=30) in NIH-led Phase 1 clinical trial completed enrollment and the results are anticipated to publish once available.
Notably, Pivotal Phase 3 clinical trial is projected to commence in July, and manufacturing of vaccine required to initiate the study has completed.
Moderna and ROVI Announce Collaboration
On 9 June 2020, Moderna disclosed that it is working in collaboration with the Laboratorios Farmacéuticos Rovi, SA (BME:ROVI) for fill-finish manufacturing of Moderna’s COVID-19 vaccine candidate.
Under this agreement, ROVI will offer vial filling and packaging facility by obtaining a new production line and equipment to provide support for manufacturing millions of doses of mRNA-1273 intended to supply in markets outside the US in early 2021.
BioNTech and Pfizer Announced Preliminary Positive Data from an Ongoing Phase 1/2 Study COVID-19 Vaccine
A forerunner in the development of novel cancer therapies and treatments for other severe disorders, BioNTech SE (NASDAQ:BNTX) is developing an mRNA-based vaccine, called BNT162, for preventing COVID-19 (in collaboration with Pfizer).
On 1 July 2020, the two partners revealed preliminary data from the most advanced of the four investigational vaccine candidates from their BNT162 mRNA-based vaccine program. Under the BNT162 program, the companies are evaluating four vaccine candidates, each representing a distinctive combination of mRNA format and target antigen.
The preliminary data demonstrated that BNT162b1 could be administered in a well-tolerated dose that generated dose-dependent immunogenicity, as determined by RBD-binding immunoglobulin G (IgG) concentrations and neutralizing antibody titers of the novel coronavirus.
Moreover, data from the ongoing Phase 1/2 study of four vaccine candidates will facilitate selection of a lead candidate along with dose level for a large, global Phase 2b/3 safety and efficacy clinical study that could commence as early as July 2020.
The Company also disclosed that it is gearing up efforts in the production of the leading candidates, at risk. In case the safety and efficacy clinical trial is successful, and the vaccine gets regulatory authorization, both the companies are anticipating producing nearly 100 million doses by the end of 2020 and possibly over 1.2 billion doses by the end of 2021.
Stock Performance
Below is the stock performance of the NASDAQ-listed healthcare companies (Post the market closure on 9 July 2020):

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