Summary
- Novavax achieved positive preliminary data in patients with COVID-19.
- Early data shows that all those who were given NVX-CoV2373 achieved anti-spike IgG antibodies and neutralization titers.
- Novavax expanded its phase 2 portion of its COVID-19 vaccine study; intends to release interim results of those, given NVX-CoV2373 by Q4 of 2020.
- A phase 2b study using NVX-CoV2373 for COVID-19 patients is being conducted in South Africa and will recruit up to 2,665 patients.
- Novavax had $609.5 million in cash as of June 30, 2020; enough cash to fund its operations for at least 12 months from the SEC filing date of August 10, 2020.
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Novavax (NASDAQ:NVAX) has continued to trade higher since the first article I wrote on the company. This article is named "Novavax Secures Covid-19 Funding and Provides Additional Value With Eventual BLA Filing Of NanoFlu Vaccine". Since then, the company has made additional value adding progress for shareholders. The most important news item being that it had achieved highly positive data from the phase 1 study using its COVID-19 vaccine product. From there, there are several deals that had been made by it to provide its vaccine to several territories around the globe. I think that the company still remains a great long-term hold on the premise of its NanoFlu vaccine progress made to date. The addition of multiple deals in multiple territories proves that the biotech has an effective technology platform.
Early Phase 1 Data Is Very Promising
The phase 1 data was early but highly promising. That's because all patients in the study were able to produce anti-spike IgG antibodies after only receiving one dose of NVX?CoV2373. What does this mean for COVID-19 patients and why is this an important finding? That's because Immunoglobulin G (IgG) is an antibody that accounts for roughly 75% of serum antibodies found in humans. These serum antibodies protect patients from various pathogens like:
- Viruses
- Fungi
- Bacteria
The achievement of all patients seeing IgG antibodies was in tandem with neutralization titers, which in turn means that the antibodies produced against COVID-19 were of the functional kind. When patients took a 2nd dose, it also translated to all of them producing a wild-type virus neutralizing antibody response. What makes this vaccine even more potent is the addition of an adjuvant known as Matrix-M. Matrix-M is an adjuvant from Novavax, which is given on top of NVX-CoV2373 to boost response. In the case of the adjuvant, it was able to induce robust polyfunctional CD4+ T-cell responses. CD4+ T-cells are good in that they are "helper cells" which are responsible for indirectly killing foreign invaders. They scope out and determine if other parts of the immune system can respond to killing the virus in question. When it is said that CD4+ T-cells (helper cells) are polyfunctional, there is a multitude of additional functions they can provide. These functions are:
- Release cytokines (cell signaling proteins)
- Release chemokines (attract white blood cells to infection)
- Mediate cytolysis (cell membrane bursting due to excessive volume overtaking the membrane itself)
With neutralization titers observed in 100% of the patients, that is an encouraging sign that NVX-CoV2373 may block cells from becoming infected. Not only was there a solid foundation of immunogenicity observed with NVX-CoV2373, but it was tolerable with no major adverse events. The first dose had some site reactions and then some symptoms such as:
- Fatigue
- Headache
- Myalgia (muscle aches ranging from mild to severe)
Dose 2 had further symptoms noted, but there is one key fact that keeps things looking good in terms of safety. This key item being that those who did experience symptoms were shown to experience ? Grade 1 types. In my opinion, this is a good finding, because this is what you would typically see with a flu vaccine. The flu vaccine also has similar mild symptoms. As such, there are some who take a flu shot and experience severe symptoms also. As far as NVX-CoV2373 is concerned, no adverse events were above Grade 1. Even those who were unlucky enough to experience mild symptoms noted above, the average duration only lasted less than 2 days. I feel that this is a tolerable safety profile. The immunogenicity and safety observed is quite compelling. Especially since there is a heavy need for many around the globe to have a functioning COVID-19 vaccine.
