mRNA

Moderna last week used its annual R&D Day to reveal interim Phase 1 data on its RSV vaccine and tout other pipeline developments.

Three different dose levels of its RSV candidate (mRNA-1345) boosted neutralizing antibody titers in adults ages 65-79 against RSV-A “approximately 14-fold” and against RSV-B “approximately 10-fold,” with no significant difference between doses, the Massachusetts-based company said. Single injections of 50 µg, 100 µg and 200 µg were well-tolerated…

Moderna will license a therapeutic candidate for an ultra-rare disease to a newly launched nonprofit “with no upfront fees” and “without any downstream payments,” the Massachusetts-based mRNA specialist announced Tuesday.

In a joint press release, Moderna said seeking a high price for this drug “is not aligned with our values”—effectively contrasting itself with other pharmas that have held on to unused intellectual property or sought premium pricing for rare disease burdens.

The…

FierceBiotech reported Monday that CureVac quietly revealed in its latest financial report that Boehringer Ingelheim is walking away from its $600 million lung cancer deal inked with the German mRNA maker in 2014.

The new setback for CureVac comes just two months after its Covid-19 mRNA shot showed only 47% efficacy at preventing any severity of the disease, the news outlet said.

Sanofi announced Tuesday that it will buy Massachusetts-based Translate Bio for approximately $3.2 billion in cash to accelerate development of mRNA-based therapeutics and vaccines.

The companies already jointly invested in a Covid-19 vaccine and a seasonal influenza shot (in Phase 1/2 and Phase 1 trials, respectively). But Sanofi is now acquiring Translate Bio outright to “unlock the potential of mRNA in other strategic areas such as immunology, oncology, and rare diseases in addition…

Germany’s BioNTech announced Monday that it is “evaluating sustainable mRNA vaccine production capacities in Africa” for a candidate malaria shot and other vaccines.

The company said in a press release it would select promising candidates for clinical development from “multiple vaccines featuring known [m]alaria targets” (such as the circumsporozoite protein) while also evaluating new antigens. First trials are planned for year-end 2022.

In the same press release, BioNTech said…

Moderna announced Wednesday that it has launched a Phase 1/2 study of mRNA-1010—its quadrivalent seasonal influenza vaccine candidate—in healthy adults in the United States.

The news follows Sanofi’s report last month that it has also begun Phase 1 trials of an mRNA-based candidate targeting A/H3N2 flu. BioNTech and Pfizer are also working on an mRNA-based flu candidate.

Mentions:

Corporate restructuring, clinical trial results, and a new business investment kept Sanofi in the news this week.

First, the company announced Monday that as part of its “ongoing efforts to reduce the complexity of its Consumer Healthcare portfolio and accelerate its growth trajectory,” it will offload 16 products to Germany’s STADA Arzneimittel. Neither firm disclosed deal terms.

The same day, Sanofi announced that its respiratory syncytial virus (RSV) single-dose monoclonal…

Health science conglomerate Danaher will acquire North Dakota-based CDMO Aldevron for approximately $9.6 billion in cash, the former announced last week. Aldevron, which manufactures plasmid DNA, mRNA and recombinant proteins for companies including Moderna, will operate as a standalone business within Danaher’s Life Sciences segment, the press release said. Danaher’s holdings include diagnostics specialists Cepheid and Beckman Coulter as well as a biologics manufacturing unit the Washington…

Promising mRNA vaccines made news again last week as the U.S. Walter Reed Army Institute of Research announced that its investigational shot against P. falciparum malaria achieved “high levels of protection” in mice. NPJ Vaccines published the study on the jab (PfCSP mRNA-LNP), co-developed with Acuitas Therapeutics and other collaborators.

In other malaria news, Life Science Alliance published details last week on a method developed by Imperial College London researchers for isolating…

Sanofi and Massachusetts-based Translate Bio have launched a Phase 1 trial of an mRNA-based seasonal flu vaccine candidate targeting influenza A/H3N2, the companies announced Tuesday. The study will evaluate two formulations of the vaccine (MRT5400 and MRT5401) in up to 280 healthy adults, per the press release. The collaborators also have a Covid-19 vaccine candidate in Phase 1/2 and plan to develop mRNA shots for up to three additional pathogens.

In other Sanofi news, a new…