Merck's IL-2 Agonist MK-6194, Acquired for $1.85 Billion, Receives IND Approval in China for Systemic Lupus Erythematosus

▎Edited by the WuXi AppTec content team

Today (February 5), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that MSD has submitted a new Class 1 drug.MSD's MK-6194 Injection Receives Clinical Trial Approval, Intended for Development in TreatmentSystemic Lupus Erythematosus。Public information shows,This isA Selective IL-2 Agonist。In February 2021, Merck & Co., Inc. announced the acquisition of Pandion Therapeutics for $1.85 billion, thereby obtaining the latter's leading investigational therapy, namelyMK-6194（PT101）。

Screenshot source:CDE Official Website

Systemic Lupus Erythematosus（SLE）Is a complex autoimmune disease,About 90% of the patients are female.In recent years, although the long-term survival of SLE patients has improved, the inevitable disease relapses and the resulting irreversible organ damage remain significant causes of death for SLE patients. These patients urgently need innovative treatment methods to achieve sustained relief of disease symptoms, control organ damage, and improve long-term survival.

Public information shows that, inIn autoimmune diseases, the immune system inappropriately attacks host cells, targetingRegulatory T cells (Tregs）Can allow the immune system to regain control and restore homeostasis.TregsAs a control node within the immune system, it can suppress the activity of various pro-inflammatory immune cell types.Multiple third-party clinical trials have shown that expanding Tregs through low-dose IL-2 can benefit patients with autoimmune diseases.。Targeted expansion of Tregs or enhancement of their suppressive activity in vivo has alreadyBecomeDevelopment of IL-2-Based DrugsA new, promising focus.

MK-6194 PositiveIs an engineered IL-2 mutant, intended for development to treatAutoimmune Disease。According to literature reports,ResearchersAdopting a structure-oriented approach,Several mutations that significantly reduce CD122 binding affinity and others that increase CD25 binding affinity were introduced into IL-2.Resulting inFc-fusion moleculeMK-6194 inIn preclinical studiesPossibleSelective Activation and Expansion of Treg, andNo significant effect on other types of immune cells, nor will it trigger the production of pro-inflammatory cytokines.

Research shows that MK-6194Can selectively bind to the IL-2 receptor trimer containing the IL-2Ra subunit on the surface of Tregs, rather than binding to the IL-2 receptor dimer on conventional T cells and natural killer cells, thereby specifically activating and expanding Tregs.。This product previouslyA Phase 1a clinical trial has been completed, demonstrating good safety and tolerability, along with proof of mechanism.