Modern (NASDAQ: MRNA) He has gone one step further to realize his dream of marketing a coronavirus vaccine. The company has just released more detailed provisional results from its phase 1 test, and they are enough for Moderna and investors to encourage.
What is so encouraging about the results? And do they really bring Moderna closer to victory? We’ll see.
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The Moderna trial included 45 healthy volunteers aged 18 to 55 years. Each participant received two doses of mRNA-1273 28 days apart at one of three dosage levels. Based on the results, Moderna chose to search for the 100 microgram dose, the mid-range dose, in late-stage trials.
Neutralizing antibody levels
The positive key in the Phase 1 data has to do with neutralizing antibodies. These are the antibodies that actually block the infection, so the ability of a vaccine to stimulate its production is crucial. Modern, in a publication in The New England Journal of Medicine, reported that all evaluated trial participants showed neutralizing antibody production. And in the 100 microgram dosage group, the levels were four times higher than those observed in recovered COVID-19 patients.
Initial data published in May only showed neutralizing antibody data for eight trial participants. Although neutralizing antibody levels were equal to or higher than those of patients who had undergone COVID-19, the sample was not large enough to demonstrate a clear trend. This latest report on the production of neutralizing antibodies in all participants is a great step forward. The results also showed T-cell responses after the second dose in the lowest dose group and in the 100 microgram dose. T cells are another important piece of the puzzle, as they are a tool of the immune system to detect and fight infections.
Moderna will attempt to replicate that positive data in up to 30,000 people when the company begins phase 3 studies on July 27.
One step closer to the finish line.
This is all good news for Moderna. The biotech company has taken a step closer to the finish line. But others have been catching up. Modern is not as advanced as it was several weeks ago.
AstraZeneca (NYSE: AZN) you are conducting a phase 2/3 test now. The United States Food and Drug Administration recently awarded the Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) Fast Track team designation for two vaccine candidates. Pfizer and BioNTech, like Moderna, are developing a vaccine using messenger RNA. Their goal is to start a phase 2b / phase 3 trial of 30,000 participants later this month. Moderna, AstraZeneca and the team at Pfizer and BioNTech are among the few drug manufacturers closest to the finish line at the moment.
Inovio Pharmaceuticals (NASDAQ: INO) and Novavax (NASDAQ: NVAX) They’re very close. Inovio plans to start a phase 2/3 study this summer, and Novavax expects to release interim phase 1/2 data later this month and then begin the phase 2 study portion soon after.
Of course, that “who’s ahead” list is all from a timeline perspective. What ultimately matters most, and will determine the winner (s), is the safety and efficacy of the vaccine candidate. Although Moderna’s results are encouraging, we still need to curb the excitement.
Here’s why: First there is the matter of neutralizing antibodies. It is still unclear how long neutralizing antibodies will remain in the body and what level of antibodies are needed to prevent infection. Another question is the performance of the vaccine in the elderly, a group very affected by COVID-19. A successful vaccine must be safe and effective in this population. Moderna is testing the vaccine on older and older volunteers in phase 2 and will also include these groups in phase 3.
What does this mean for investors?
Moderna’s shares have risen 315% since the beginning of the year. The company does not yet have any products on the market. In addition to the COVID-19 vaccine, Moderna’s most advanced candidate is in phase 2 studies. That means that if the Moderna vaccine fails, the company is still years away from marketing a product.
In the short term, with good news, this biotech stock is likely to have more to gain. And if Moderna’s vaccine is successful, actions can skyrocket. But if the company loses this race or produces a vaccine that is not as strong as a rival’s, the result can be devastating to actions. That’s why, for now, long-term investors may want to watch Moderna’s final sprint all the way from the sidelines.
