Summary
- Novavax received $384 million in funding from the Coalition of Epidemic Preparedness Innovations to develop NVX-CoV2373 as a vaccine for COVID-19.
- Matrix-M is a proprietary technology of the company, which is an adjuvant for NVX-CoV2373 to boost immune response and generate higher levels of neutralizing antibodies.
- Another vaccine candidate in the pipeline, NanoFlu, has already shown to be successful in a phase 3 study for older patients ages 65 and older for the flu.
- Preliminary immunogenicity and safety data from NVX-CoV2373 for COVID-19 expected July of 2020, which will be a major catalyst.
- This idea was discussed in more depth with members of my private investing community, Biotech Analysis Central. Get started today ยป
Novavax (NASDAQ:NVAX) recently announced that it had received $384 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI), to develop its COVID-19 vaccine known as NVX-CoV2373. A study had already been initiated for NVX-CoV2373, and initial data will be revealed in July of 2020. What makes this biotech a good investment is not just the potential that it holds in developing a COVID-19 vaccine. It has all but reduced risk for its NanoFlu vaccine, which is its seasonal influenza vaccine for adults ages 65 and older. This program has already been de-risked, because NanoFlu had already demonstrated non-inferiority to another vaccine known as FluZone. With this data on hand, Novavax believes that the phase 3 data will allow it to file a BLA to the FDA under the accelerated approval pathway. Based on these developments, I view Novavax as a solid buy.
CEPI Funding Provides Vaccine Technology Validation
Novavax announced that CEPI will invest up to an additional $384 million to help advance NVX-CoV2373. The newest cash influx was a huge surprise. That's because, back in March of 2020, CEPI had only given the biotech $4 million in funding to help advance this Covid-19 vaccine. This program is in good shape, especially because this clinical candidate was selected back in January of 2020. Novavax had already initiated recruitment for its phase 1/phase 2 study this month. It will be a placebo-controlled study of 130 patients, to determine proper dosage. Preliminary immunogenicity and safety data will be released in July of 2020. That's only a few months away, and it will give a glimpse of how well the vaccine protects against the virus. It's hard to say how well the data will turn out, but NVX-CoV2373 will make use of the company's proprietary Matrix-M technology. That's important, because Matrix-M is an adjuvant that is supposed to boost the immune response and generate higher levels of neutralizing antibodies. As I will explain below, Matrix-M has already done well to boost the effect of NanoFlu on older adults for the seasonal flu vaccine.
NanoFlu Is An Even More Promising Vaccine Candidate
There is no doubt that the funding for NVX-CoV2373 for COVID-19 is a welcomed piece of news. It is hard to say how well preliminary results are when they are released in July of 2020. However, this biotech is already in good shape since it has already passed a phase study using NanoFlu for older adults ages 65 and older for a Seasonal Influenza vaccine. In order to prove that NanoFlu works for the prevention of influenza in older patients 65+, Novavax ran a large phase 3 study. This phase 3 study enrolled a total of 2,652 healthy older adults across 19 sites in the United States. The thing is that patients were either treated with NanoFlu or the comparator in the study. Each of these vaccines used had four influenza strains which were thought to be crucial protection for the 2019 to 2020 flu season. The comparator in this study is known as FluZone. The primary endpoint (goal) was to see if NanoFlu was non-inferior in terms of immunogenicity by hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains, compared to FluZone. The primary endpoint was achieved in terms of non-inferiority. In addition, there were two secondary endpoints that were also met:
- 28 ratio of geometric mean titers (GMT)
- The difference of the two products in seroconversion rates (SCR)
The secondary endpoints were met in all 4 strains that were used for the vaccine. With GMT responses, NanoFlu had a higher response ranging from 24% to 66%. In terms of SCR percentage points, the numbers ranged 11.4 to 20.4 higher than FluZone. Safety was also found to be tolerable for NanoFlu. There were some more moderate adverse events found in the vaccine, but not enough to make a major difference between it and the comparator. I think what will also really help this vaccine on the market, in terms of sales, is that the secondary endpoints were met. The vaccine literally worked for all endpoints tested for this study, which makes these results that much more robust in my opinion. Novavax is currently preparing its BLA filing package to hand to the FDA so that it may eventually obtain FDA approval of NanoFlu.
