Moderna Inc (MRNA)

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BIG NEWS OUT: MODERNA REVIEWS CLINICAL TRIAL PROGRAMS ACROSS PORTFOLIO AT 2022 R&D DAY


Interim data from Phase 1/2 propionic acidemia (PA) multi-dose Paramount trial shows mRNA-3927 was well-tolerated to date, with encouraging early signs of potential for clinical benefit

Interim data from Phase 1/2 glycogen storage disease 1a (GSD1a) single-dose Ba1ance trial shows mRNA-3745 was well tolerated to date, with encouraging early signs of potential for clinical benefit

Moderna announces a new development candidate, mRNA-3139, for ornithine transcarbamylase (OTC) deficiency, a rare genetic disorder

Phase 3 clinical trial of RSV vaccine, mRNA-1345, has enrolled more than 24,000 of the 34,000-participant target

Phase 3 immunogenicity and safety study of flu vaccine, mRNA-1010, is fully enrolled; Company to pursue accelerated approval pathway in 2023

Company is on track to report data from its Phase 2 personalized cancer vaccine (PCV) study in 4Q 2022

Personalized Cancer Vaccine

Personalized cancer vaccines (PCV) target an individual patient's unique tumor mutations to selectively treat their cancer. Moderna's PCV program is being developed in collaboration with Merck.
mRNA-4157 is a PCV candidate designed to stimulate an immune response by boosting T cells, which are believed to be necessary for a curative cancer therapy. Moderna's Phase 2 clinical trial will determine if mRNA-4157 in combination with KEYTRUDA®, an approved cancer therapy, can improve recurrence-free survival (at 12 months) in patients with resected melanoma at high risk of recurrence, compared to KEYTRUDA alone. KEYTRUDA was selected as the comparator in the trial because it is considered the standard of care for high-risk melanoma patients.
The Phase 2 trial is fully enrolled and primary data are expected in 4Q 2022.

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