Moderna regains all rights to RSV vaccine from Merck

Separately, Moderna also announced the initiation of dosing in the Phase 1 study of its solely owned RSV vaccine candidate (mRNA-1345). This Phase 1 study includes initial dosing in adults, followed by age de-escalation into children. The company previously announced its intent to advance mRNA-1345 in children in combination with mRNA-1653, a vaccine against two other pediatric respiratory viruses (hMPV, PIV3) which is currently in its own age de-escalation study. With today’s announcement, Moderna will have the right to also advance RSV vaccines in adults, either alone or in combination with other respiratory virus vaccines.

Moderna and Merck will continue their ongoing collaboration in cancer vaccines. In 2016, Moderna and Merck entered into a collaboration for mRNA-4157, a personalized cancer vaccine candidate, which is currently being evaluated in a Phase 2 study. In 2018, the companies expanded the collaboration to include the development and commercialization of mRNA-5671 a mutant KRAS vaccine candidate currently in a Phase 1 study.

Moderna’s mRNA-1345 vaccine uses the Company’s proprietary lipid nanoparticle delivery technology also used in the Company’s *redacted* vaccine (mRNA-1273) and CMV vaccine (mRNA-1647).

Moderna completes enrollment in ph 2 study of mRNA-1273, ready for ph 3 in 30000 participants

Moderna highlights diverse research at their third annual science day

At this year’s virtual Science Day, Moderna will present new platform science and preclinical research, including: 

Engineering mRNA and Proteins to Improve Therapeutic Properties – advantage of mRNA medicines over small molecule drugs is the ease of engineering their properties to achieve desired pharmacology. New research will be presented on efforts to engineer both mRNAs and encoded proteins to improve and extend therapeutic effect. At Science Day, Moderna will present a protein engineering workflow by which it has engineered a Moderna T7 RNA polymerase (MT7) that does not produce dsRNA impurities. 

Optimizing Lipid Nanoparticle Technology – the Company will present new research in delivery science to optimize its lipid nanoparticles (LNPs). The presentations will highlight a novel squaramide-based ionizable lipid designed to enhance the interactions between the lipid and mRNA. Preclinical data from new LNPs incorporating this novel ionizable lipid show improved protein expression after IV administration, including repeat dosing, and efficient delivery to the liver, as compared to current state-of-the-art Moderna proprietary LNPs. 

Collaborating on an HIV Vaccine – research conducted through Moderna’s ongoing collaborations with International Aids Vaccine Initiative (IAVI), National Institute of Allergy and Infectious Diseases (NIAID) and the Bill & Melinda Gates Foundation, will be showcased. This research seeks to deliver an engineered HIV immunogen using Moderna’s mRNA platform that allows for a faster, more flexible approach to rapid iterative vaccine design and clinical testing.

across Moderna’s pipeline

Encouraging interim data from ph 1 trial of Moderna’s redacted vaccine candidate mRNA-1273

mRNA-1273 was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies. 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. To date, 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. All adverse events have been transient and self-resolving. No grade 4 adverse events or serious adverse events have been reported.

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). 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 participants ages 18-55 (n=15 per cohort) across all three dose levels seroconverted by day 15 after a single dose. 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 redacted) 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. Samples are not yet available for remaining participants.

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

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.

Modern’a redacted vaccine candidate cleared for phase 2


Moderna (NASDAQ:) says the FDA has given the green light to begin the Phase 2 study on its redacted redacted vaccine (mRNA-1273).

It’s expected to start imminently, with the goal of a Phase 3 study to begin in early summer, and approval as soon as 2021.

This is important because Moderna is ahead of everyone else in the redacted vaccine battle.