Moderna, Inc. MRNA announced positive updated interim data from a phase I study evaluating its mRNA-based coronavirus vaccine candidate, mRNA-1273. The data demonstrated that participants vaccinated twice with mRNA-1273 induced rapid and strong immune responses against SARS-CoV-2 in all patients through day 57, across all three dose cohorts.
The data also showed that all participants were seroconverted (producing antibody against SARS-CoV-2 Spike protein) by day 15. The safety profile of the vaccine looks promising as no serious adverse events were reported through Day 57 while adverse events were generally transient and mild to moderate in severity.
Participants achieved levels of antibodies similar or higher than those typically found in a patient who recovered from COVID-19 naturally. The phase III selected dose of 100 µg dose showed more than four times neutralizing antibody compared to reference convalescent sera. Please note that the phase I study was conducted by the National Institute of Allergy and Infectious Diseases.
T cell responses were also observed following second vaccination with 25 µg and 100 µg dose levels.
The study continues to evaluate the durability of immune responses. Blood samples of participants will be evaluated regularly for one year following the second vaccination. The study has also added seven new cohorts to evaluate a new dose level (50 µg) and three cohorts each for older adults (ages 56-70) and elderly adults (ages 71 and above).
Shares of Moderna were up 17% in pre-market trading on Jul 15, following the encouraging study data on the coronavirus vaccine candidate. In fact, the company’s shares have skyrocketed 283.8% so far this year compared with the industry’s increase of 7.8%, primarily due to the company’s progress with its coronavirus vaccine candidate.
Moderna has completed enrollment in a phase II study on mRNA-1273, which the company is conducting under its own investigational new drug application last month. The study is evaluating 50 µg and 100 µg doses of mRNA-1273.
Moreover, the company has finalized the design for a phase III study on mRNA-1273 and anticipates to initiate the study on Jul 27. The study will evaluate the 100 µg dose in approximately 30,000 patients for prevention of symptomatic COVID-19 disease. On the back of these positive developments, Jefferies provided bullish commentary earlier this week.
However, we note that the presence of several large pharma players in the coronavirus vaccine field is likely to increase competition. Pfizer PFE in collaboration with a Germany-based biotech, BioNTech SE BNTX, is developing four mRNA-based vaccines for COVID-19. Moreover, the FDA recently granted Fast Track designation to its two most advanced vaccine candidates. Other big pharma companies developing vaccines for COVID-19 include J&J JNJ, AstraZeneca, Merck and Sanofi in collaboration with Glaxo.
Moderna, Inc. Price
Moderna currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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