Moderna (MRNA): Stock Surges Due To Positive Phase 1 Coronavirus Vaccine Data

By Amit Chowdhry ● May 18, 2020
  • Moderna Inc (NASDAQ: MRNA) saw a sharp jump in price today due to the company announcing positive interim clinical data of mRNA-1273

On Friday, shares of Moderna Inc (NASDAQ: MRNA) were trading at about $66.43 and now it is trading at about $79.26. The sharp jump in price today was due to the company announced positive interim clinical data of mRNA-1273 — which is its vaccine candidate against novel coronavirus (SARS-CoV-2) — from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

The immunogenicity data are currently available for the 25 µg and 100 µg dose level (ages 18-55) after two doses (day 43) and at the 250 µg level (ages 18-55) after one dose (day 29). And dose dependent increases in immunogenicity were seen across the three dose levels and between prime and boost within the 25 µg and 100 µg dose levels. All of the participants ages 18-55 (n=15 per cohort) across all three dose levels seroconverted by day 15 after a single dose. And at day 43 (two weeks following the second dose) at the 25 µg dose level (n=15), levels of binding antibodies were at the levels seen in convalescent sera (blood samples from people who have recovered from COVID-19) tested in the same assay. At day 43 at the 100 µg dose level (n=10), levels of binding antibodies significantly exceeded the levels seen in convalescent sera. Currently, samples are not yet available for remaining participants.

Currently, neutralizing antibody data are available only for the first four participants in each of the 25 µg and 100 µg dose level cohorts. And consistent with the binding antibody data, mRNA-1273 vaccination elicited neutralizing antibodies in all 7 of these participants as measured by plaque reduction neutralization (PRNT) assays against live SARS-CoV-2. The levels of neutralizing antibodies at day 43 were at or above levels generally seen in convalescent sera.

mRNA-1273 was generally safe and well-tolerated with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies. And the sole incidence of a grade 3 adverse event in the 25 µg and 100 µg dose cohorts was a single participant at 100 µg who experienced grade 3 erythema (redness) around the injection site.

So far, the most notable adverse events were seen at the 250 µg dose level, comprising three participants with grade 3 systemic symptoms, only following the second dose. And all adverse events have been transient and self-resolving. No grade 4 adverse events or serious adverse events have been reported.

The preclinical results from a viral challenge study in mice conducted in collaboration with NIAID and its academic partners are also available. And in this study, vaccination with mRNA-1273 prevented viral replication in the lungs of animals challenged with SARS-CoV-2. Plus neutralizing titers in Phase 1 clinical trial participants at the 25 µg and 100 µg dose levels were consistent with neutralizing titers that were protective in the mouse challenge model.

And based on the interim Phase 1 data, the Moderna-led Phase 2 study will be amended to study two dose levels — 50 µg and 100 µg — with the aim of selecting a dose for pivotal studies. The NIAID-led Phase 1 study is being amended to include a 50 µg dose level cohort across each of the three age groups. Moderna anticipates the dose for the Phase 3 study to be between 25 µg and 100 µg and expects Phase 3 trial initiation in July, subject to finalization of the clinical trial protocol.

The funding from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), supported the planning for the Phase 2 and Phase 3 studies of mRNA-1273 and will also support the execution of these studies as well as the scale-up of mRNA-1273 manufacturing both at the Company’s facilities and that of its strategic collaborator, Lonza Ltd.

Key Quotes:

“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg. When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”

– Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna

“With today’s positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July and, if successful, file a BLA. We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2.”

– Stéphane Bancel, Chief Executive Officer at Moderna