Moderna Therapeutics announced important advances in its mRNA development pipeline, demonstrating the increasing productivity of its platform, including its first mRNA program to enter phase 2, new infectious disease vaccine and oncology programs entered into Phase 1 clinical studies, and the ongoing expansion of its pipeline with several new development candidates (DCs). A leader in mRNA science and development, Moderna continues to make notable progress across its broad, diverse pipeline, which now includes 19 mRNA drug candidates spanning infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases. The company announced several new advances including: A Phase 2a study of mRNA AZD8601, a localized mRNA therapeutic encoding for vascular endothelial growth factor, VEGF-A, being developed in partnership with AstraZeneca. Information on the clinical study, including design and target indication, will be detailed in the coming weeks. Led by AstraZeneca, this will be Moderna’s first phase 2 study. A new development candidate, mRNA-3927, for a rare disease within the liver modality. mRNA-3927 directs liver expression of a deficient enzyme in patients with propionic acidemia (PA), a serious and potentially life-threatening rare disease, which is part of a family of disorders known as organic acidemias. There are no approved therapies or ongoing clinical trials for PA. In September, Moderna announced its first rare disease DC, mRNA-3704, to treat methylmalonic acidemia, or MMA, another serious and often deadly organic acidemia. The filing of an investigational new drug (IND) application for mRNA-5671, a KRAS cancer vaccine. KRAS is one of the most frequently mutated oncogenes in human cancer (approximately 30% of all cases). mRNA-5671 encodes for the four most commonly found KRAS mutations, which will cover most of the mutations that occur in non-small cell lung cancer, colorectal cancer and pancreatic cancer. The initiation of two phase 1 prophylactic vaccine studies for mRNA-1647, a cytomegalovirus (CMV) vaccine, and mRNA-1653, a human metapneumovirus and parainfluenza virus type 3 (HMPV+PIV3) combination vaccine. CMV is the most common cause of newborn disability and the most frequent viral disease in transplant recipients, often leading to transplant failure. mRNA-1647 is made of 6 mRNAs, one coding for the herpesvirus glycoprotein (gB) antigen and 5 coding for the pentamer. HMPV and PIV3 are the second and third most common causes, respectively, of lower respiratory hospitalizations in children, behind respiratory syncytial virus (RSV). Currently, there are no approved vaccines for CMV, HMPV or PIV3. A new development candidate, mRNA-1944, which directs liver expression of an antibody that can potentially neutralize chikungunya virus circulating in the blood. Moderna has a Phase 1 study underway for a prophylactic vaccine, mRNA-1388, to prevent infection from the chikungunya virus. An antibody approach would be more desirable in certain settings, such as in immuno-compromised populations, when rapid post-exposure treatment or prophylaxis is warranted, or when protection is needed only for short periods of time. This program is sponsored by DARPA.