CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Moderna, Inc.. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the first participant has been dosed in the Phase 1 study of mRNA-6231, the Company’s mRNA-encoded IL-2 modified for the expansion of regulatory T cells. mRNA-6231 is Moderna’s first autoimmune candidate to enter the clinic. It is also Moderna’s first subcutaneously administered therapeutic program.

“The initiation of the Phase 1 study of mRNA-6231 is an important milestone for Moderna, as we now look to bring the potential of mRNA therapeutics to people living with autoimmune diseases,” said Ruchira Glaser, MD, Sr. Vice President and Therapeutic Area Head, Rare Disease, Autoimmune & Cardiovascular. “This is our first mRNA autoimmune candidate, and the first to be subcutaneously administered. Today marks another important step in our mission to deliver on the promise of mRNA to help patients across diseases.”

Moderna now has active clinic programs in five different therapeutic areas: infectious disease, oncology, cardiovascular, rare disease and autoimmune disease.

About mRNA-6231

mRNA‑6231 is a lipid nanoparticle (LNP)‑encapsulated mRNA-based therapeutic that encodes for mutein human interleukin 2, fused to human serum albumin (HSA‑IL2m), with the goal of achieving enhanced selectivity toward T regulatory cells. IL-2 through preferential expansion of Tregs is hypothesized to play a central role in restoring immune homeostasis.

The trial is a Phase 1, first‑in‑human, dose‑escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of mRNA‑6231 in healthy adult participants (between 18 and 50 years of age), following subcutaneous administration of a single dose of mRNA‑6231.

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both ground-breaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 16 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company’s conduct of clinical trials for IL-2 (mRNA-6231); and the potential for mRNA-6231 to achieve enhanced selectivity toward T regulatory cells. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.

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