Business WireJanuary 12, 2020Comment
Moderna Builds on Clinical Validation of Systemic Delivery with Two Additional Development Candidates in New Autoimmune Therapeutic Area
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mRNA-6231 encodes a long-acting selective IL-2 to preferentially expand regulatory T cells that suppress immune activity in autoimmune diseases
mRNA-6981 encodes PD-L1 to treat autoimmune disease, initially to be developed in autoimmune hepatitis
Company to expand pipeline of innovative vaccines in the near term based on clinical success of infectious disease vaccine portfolio to date
Moderna, Inc. (Nasdaq: MRNA), a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today 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. Today’s announcement reflects the Company’s belief that recent positive Phase 1 data from its infectious disease vaccine portfolio, including its complex CMV vaccine, and chikungunya antibody program have de-risked its prophylactic vaccines and systemic therapeutics modalities. As a result, Moderna intends to bring new development candidates forward within these two areas.
"2019 was an inflection point for Moderna with significant clinical advances resulting from our investments in science and manufacturing capabilities. The positive Phase 1 results from our CMV vaccine and chikungunya antibody programs validate our approach and help clinically de-risk the delivery technologies for our prophylactic vaccines and systemic therapeutics modalities. Based on these learnings, we are excited to enter a new therapeutic area in autoimmune disease and announce two new development candidates," said Stéphane Bancel, Moderna’s chief executive officer. "We are entering 2020 with clear priorities, a strong cash balance and a talented team of employees focused on achieving our mission. With our CMV vaccine, we are preparing for our first pivotal Phase 3 study and we look forward to announcing additional new development candidates in our two clinically de-risked modalities, prophylactic vaccines and systemic therapeutics."
Mr. Bancel will present an update on the Company and its pipeline of mRNA development programs on Monday, January 13, 2020 at 4:30 p.m. PT at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco. The presentation will be followed by a question and answer session. A live webcast of both the presentation and question and answer session will be available under "Events & Presentations" in the investors section of Moderna’s website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for 30 days following the presentation.
Moderna currently has 21 mRNA development candidates in its portfolio with 13 in clinical studies. Across Moderna’s pipeline, more than 1,500 participants have been enrolled in clinical studies. The Company’s updated pipeline can be found at www.modernatx.com/pipeline.
About 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.
