With the launch of the clincial trial for mRNA-6231, the company’s mRNA-encoded IL-2 modified for the expansion of regulatory T cells, the company now has active clinic programs in five different therapeutic areas: infectious disease, oncology, cardiovascular, rare disease and autoimmune disease.
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.
“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.”
Potential in therapeutics
Moderna’s headline work has been in mRNA vaccines, developing its COVID-19 vaccine and taking flu and HIV vaccine candidates into the clinic this year, among other programs.