Moderna mRNA Portfolio on Track to Hit 2025 Goal with Nipah Virus Trial Launch

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Moderna announced Tuesday that it has dosed the first participant in a Phase I clinical trial of mRNA-1215, a vaccine designed to fight the Nipah virus (NiV).

Moderna developed the vaccine in collaboration with the Vaccine Research Center, a division of the National Institute of Allergy & Infectious Diseases (NIAID) at the National Institutes of Health (NIH). The trial will evaluate the safety, tolerability and immunogenicity of the NiV vaccine in healthy adults.

NiV is a zoonotic virus, a virus that spreads between animals and people and has a high mortality rate, as 40 to 75% of those infected dies from the virus. The pathogen causes a rapidly progressive disease, which includes acute respiratory infection and encephalitis that can lead to coma or death.

Moderna Making the Most of mRNA Portfolio

mRNA-1215 is just one in a large portfolio of mRNA vaccines that Moderna is studying in clinical trials. The company recently advanced its Zika virus vaccine candidate to Phase II clinical trials and has ongoing clinical trials for vaccines against HIV. Overall, the company has launched four of the 15 priority vaccine programs it is committed to developing by 2025.

As Moderna advances its mRNA vaccine pipeline, other companies are following suit. 

Crowded mRNA Influenza Vaccine Space

Several companies are on the prowl to introduce an mRNA vaccine for influenza, including Moderna, which recently entered into a Phase III clinical trial for its candidate mRNA-1010. The asset is intended to be a seasonal influenza vaccine.

CureVac, which recently made headlines for launching a patent infringement lawsuit against BioNTech related to mRNA vaccine technologies, is in collaboration with GSK to develop an influenza mRNA vaccine. In February, the companies announced that the first participant was dosed in a Phase I clinical trial with their multivalent influenza vaccine candidate designed to target four different influenza strains.

In 2021, Sanofi acquired Translate Bio and its mRNA vaccine portfolio and is currently developing an influenza vaccine. The companies initiated a Phase I clinical trial in June 2021. Late last year, Pfizer also launched a Phase I exploratory clinical trial to evaluate its quadrivalent mRNA vaccine against influenza.

Could mRNA Prevent Pancreatic Cancer?

Cancer has been an important target for mRNA vaccines. Currently, Moderna has several mRNA vaccine candidates in clinical trials for oncology indications. These include a personalized cancer vaccine and a KRAS vaccine targeting KRAS mutations present in approximately 25% of malignant tumors that drive 85 to 90% of pancreatic cancer cases.

Memorial Sloan Kettering Cancer Center is also working on an mRNA vaccine candidate for pancreatic cancer. In May, the institution announced that the custom-made vaccines activated T cells that recognized and attacked pancreatic cancer in 50% of the patients studied, and the patients showed a delayed recurrence of their pancreatic cancers.

BioNTech is also working on an individualized cancer vaccine that encodes up to 20 patient-specific tumor neoantigens, with the goal of inducing an immune response against the malignant tumor. The company currently has clinical trials underway in colorectal cancer, solid tumors and melanoma. It is also working on an mRNA cancer vaccine specific to three ovarian cancer-associated antigens designed to produce a strong immune response in patients with the antigens.