- Search for a safe and effective vaccine for COVID-19 is gaining momentum. While some healthcare players are in initial stages of clinical studies, some have already revealed the time frame for late-stage trials and possible approval of their candidates.
- Moderna to commence Phase 3 clinical trials for mRNA-1273 in July 2020, while AstraZeneca strengthens its manufacturing capacity for AZD1222.
- Sinovac Biotech will initiate Phase 3 clinical trial shortly for CoronaVac.
- BioNTech secures €100 million for COVID-19 vaccine production; Novavax to raise ~US$200 million for COVID-19 and flu vaccine.
- INOVIO to begin Phase 1/2 Clinical Trial in South Korea while CureVac obtained regulatory approval from regulatory authorities in Belgium and Germany to start Phase 1 clinical study.
COVID-19 threat still looms with countries struggling to eliminate the novel coronavirus, SARS-CoV-2. While most geographies are grappling with the first wave of virus, the ones who did become COVID-19-free are now facing the second wave. Globally, confirmed cases of COVID-19 had crossed 8.86 million including 465,740 deaths, as per WHO (as of 3:50 PM CEST, 22 June 2020).
The quest for a vaccine to combat COVID-19 has reached its pinnacle, with many burgeoning healthcare companies joining the race to develop a safe and effective COVID-19 vaccine. While some companies have progressed to early-stage clinical trials, some have already announced the initiation of late-stage development and are expanding their manufacturing facilities.
Meanwhile, the US recently launched Operation Warp Speed (OWS) for immense COVID-19 vaccine testing with an aim to provide a vaccine by the end of this year. Operation Warp Speed intends to deliver nearly 300 million safe and effective doses of vaccine for COVID-19 by January 2021. OWS is a part of a comprehensive approach for fast-tracking three core areas development, production, along with distribution of COVID-19 diagnostics, therapeutics, and vaccines.
In this article, we will highlight companies who are in the race of developing COVID-19 vaccine:
Moderna to Begin Phase 3 Clinical Trials of mRNA-1273 in July
NASDAQ-listed healthcare sector player Moderna Inc (NASDAQ:MRNA) stated that the Company had finalised the Phase 3 clinical trials protocol per the feedback provided by the US FDA. Moderna highlighted that the trial is anticipated to enrol nearly 30k participants in the US, and it would be a randomised, placebo-controlled clinical trial.
Moreover, the Phase 3 clinical trial is projected to be conducted in partnership with NIAID, which is a part of the NIH (National Institutes of Health).
Stock Information: On 22 June 2020, MRNA shares closed at US$64.75, down by 2.41%, with a market cap of ~US$24.04 billion.
AstraZeneca Bolsters Manufacturing Capacity, Moving Progressively With AZD1222
UK-based global, science-led biopharmaceutical company AstraZeneca plc (NASDAQ:AZN) disclosed that AstraZeneca and Catalent Biologics signed an agreement for manufacturing and supply of AZD1222, vaccine candidate by University of Oxford.
With this contract, Catalent will offer vial filling along with packaging capacity to AstraZeneca at its Italy-based production site.
Addition to this, AZN signed a deal with Inclusive Vaccines Alliance Europe for offering Oxford University’s vaccine, the supplies will begin by the end of 2020 in Europe.
The University had announced Phase 2/3 study initiation in the UK in May with studies in other geographies due to begin soon.
Stock information: On 22 June 2020, AZN stock settled the day’s trade at US$53.42, up by 0.75%, with a market cap of nearly US$140.2 billion.
A pioneer in developing novel therapies for cancer and other severe disorders, BioNTech SE (NASDAQ:BNTX) is developing mRNA-based vaccine BNT162 for preventing COVID-19, in collaboration with Pfizer.
On 11 June 2020, BioNTech disclosed that it had signed a debt financing agreement worth approximately €100 million with the European Investment Bank for the development and manufacturing of its COVID-19 vaccine program for BNT162.
With this deal, BioNTech will expand its production capacity for supplying the vaccine swiftly around the world in response to the ongoing turmoil.
Stock Information: On 22 June 2020, BNTX ADS closed the day’s trade at US$57.45, surged by 11.86% from its previous close. The market capitalisation of the stock stood at US$13.03 billion.
Sinovac Disclosed Positive Preliminary Results of Phase 1/2 Trial, Soon to Enter in Phase 3
China-based leading provider of biopharmaceutical products, Sinovac Biotech Ltd (NASDAQ:SVA) has developed a vaccine named as CoronaVac that uses an inactive novel coronavirus to generate an immune response against the active version of the virus.
On 13 June 2020, Sinovac Biotech disclosed positive initial findings from its Phase 1/2 trial of CoronaVac, COVID-19 vaccine candidate of Sinovac. The findings show positive safety as well as immunogenicity reports. Furthermore, SVA foresees to submit a report for the Phase 2 clinical trial and a clinical study protocol for Phase 3 to NMPA China and commence the application of Phase 3 clinical trial outside of China.
As per a release dated 11 June 2020, the Company disclosed its collaboration with Instituto Butantan, a research institute in Brazil, for designing and performing a Phase 3 trial. Sinovac anticipates sharing the complete data on clinical trials publicly via academic publications.
Stock Information: SVA ordinary shares last quoted at US$6.47 on 22 June 2020, in line with the previous close, with a market capitalisation of approximately US$639.9 million.
Novavax to Raise US$200 Million to Fund COVID-19 and Flu Vaccine Studies
A late-stage biotechnology company Novavax Inc (NASDAQ:NVAX) is developing a vaccine, NVX-CoV2373 against SARS-CoV-2.
As per the announcement dated 15 June 2020, NVAX revealed that it had entered an agreement to offer Convertible preferred stock (Series A), changeable into almost 4,388,852 shares of ordinary stock, to an RA capital investing fund affiliated within a private placement. The effective buying per share price of common stock for this agreement was equivalent to the last stock price on 12 June 2020. Notably, on completing this agreement, NVAX will obtain gross profits of almost US$200 million.
The rise in investment of Novavax, along with resources from CEPI and the US Department of Defense, will provide support to the Company in developing an effective and accessible vaccine to combat COVID-19.
Stock Information: On 22 June 2020, NVAX last quoted at US$65.95, up by 1.85% from its last close, with a market cap of almost US$3.87 billion.
INOVIO to Commence Phase 1/2 Clinical Trial in South Korea
US-based biotech player INOVIO Pharmaceuticals Inc (NASDAQ:INO), the Seoul National University Hospital, and IVI (the International Vaccine Institute) are working in a partnership to begin a Phase 1/2 clinical study of INO-4800 INOVIO's COVID-19 vaccine in South Korea.
This trial will evaluate the safety, tolerability, as well as immunogenicity of vaccine candidate nearly in forty healthy volunteers of 19-50 years and will expand to enrol further 120 volunteers in the age bracket 19-64 years.
The clinical trial intends to start later in June and is funded by the CEPI via INOVIO and is backed by the Korea Center for Disease Control (KCDC) and Korea National Institute of Health.
Stock Information: On 22 June 2020, INO last quoted at US$ 15.30, up by 7.22% from its previous close. The Company had a market cap of ~US$2.41 billion.
CureVac AG to Commence Phase 1 Trial of its Vaccine Candidate for SARS-CoV-2
A leading clinical-stage biotechnology company, CureVac AG is engaged in developing a novel category of transformative medicines based on optimised mRNA. The Company is developing mRNA based vaccine to inhibit SARS-CoV-2, which uses nucleotides with no chemical modifications in the mRNA to encode the full-length spike protein of novel coronavirus. CureVac commenced its vaccine program in early 2020.
On 15 June 2020, the German Federal Government revealed that it would invest €300 million in CureVac through the KfW group.
On 17 June 2020, CureVac disclosed that it had obtained approval from regulatory authorities of Belgium and Germany to start Phase 1 clinical study of its mRNA based vaccine candidate. The trial will commence swiftly and will be conducted in Belgium and Germany.