Moderna, Inc. announced that it has entered a new autoimmune therapeutic area. Building on the clinical validation of systemic delivery of mRNA provided by data from its antibody against the chikungunya virus (mRNA-1944) program, this new therapeutic area will include autoimmune and inflammatory diseases. The company also announced that it will expand its pipeline of innovative vaccines in the near term, following six positive Phase 1 clinical trial readouts from its infectious disease portfolio and the initiation of a Phase 2 study for its CMV vaccine (mRNA-1647). Moderna’s pipeline is organized into six modalities based on similar mRNA technologies, delivery technologies and manufacturing processes. The Company’s approach is to leverage early programs within a modality to generate clinical data and insights that reduce the technology risk of subsequent programs and accelerate the expansion of the pipeline in that modality. Moderna’s New Autoimmune Therapeutic Area: Autoimmune diseases are characterized by immune activation in response to antigens normally present in the body, reflecting a loss of tolerance. Within this therapeutic area, the Company is developing two potential medicines, mRNA-6231 and mRNA-6981, designed to engage peripheral tolerance pathways to dampen autoimmune activation and help restore immune homeostasis, thereby reducing autoimmune pathology. mRNA-6231 is an mRNA encoding for a long-acting IL-2 mutein designed to preferentially activate and expand the regulatory T cell population, dampening the immune response. mRNA-6981 is an mRNA encoding for PD-L1 and is designed to augment cell surface levels of PD-L1 on myeloid cells, providing co-inhibitory signals to self-reactive lymphocytes. As an initial step to addressing a range of autoimmune indications, the Company plans to conduct a Phase 1 study of mRNA-6231 in healthy adult volunteers and intends to pursue proof-of-concept with mRNA-6981 in a Phase 1 study in type 1 autoimmune hepatitis (AIH), a condition that involves liver inflammation and can lead to cirrhosis and liver failure. The Phase 1 study of mRNA-6231 will be the first clinical demonstration of subcutaneous administration of this delivery technology. Both of these new autoimmune development candidates share the same delivery technology as mRNA-1944, the antibody against chikungunya, reducing technology risk. The autoimmune therapeutic area is Moderna’s fifth therapeutic area, in addition to infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases. Program Updates by Modality: Prophylactic vaccines: Moderna is developing vaccines against viral diseases where there is unmet medical need " including complex vaccines with multiple antigens for common diseases, as well as vaccines against threats to global public health. Serious infections transmitted from mother to baby: Cytomegalovirus (CMV) vaccine (mRNA-1647): Moderna recently announced positive seven-month interim data after the third and final vaccination from the Phase 1 study of mRNA-1647, as well as dosing of the first participant in the Phase 2 dose-confirmation study of mRNA-1647. Manufacturing and planning are underway for the pivotal Phase 3 study designed to evaluate the efficacy of mRNA-1647 against primary CMV infection in a population that includes women of childbearing age, expected to start in 2021. Moderna owns worldwide commercial rights for mRNA-1647. Zika virus (mRNA-1893): The 10 µg and 30 µg cohorts in the Phase 1 study of mRNA-1893 have been fully enrolled. This development candidate is being developed in collaboration with the U.S. Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. Moderna owns worldwide commercial rights to mRNA-1893. Serious respiratory infections: Human metapneumovirus (hMPV) and parainfluenza type 3 (PIV3) vaccine (mRNA-1653): The first participant in the Phase 1b age de-escalation study of hMPV/PIV3 vaccine (mRNA-1653) has been dosed. Moderna previously announced positive data from the second pre-planned interim analysis of the Phase 1 study of mRNA-1653. Moderna owns worldwide commercial rights to mRNA-1653. Respiratory syncytial virus (RSV) vaccine (mRNA-1172 or V172): The Phase 1 study of mRNA-1172 led by Merck is ongoing. Moderna has licensed worldwide commercial rights to mRNA-1172 to Merck.