
Pharmaceutical R&D and Manufacturer
▎Edited by the WuXi AppTec content team
On November 27, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that Merck & Co., Inc. (MSD) had submitted a Class 1 new drug application.The clinical trial application for MK-6194 injection has been submitted and accepted.Public information shows,MK-6194(PT101) 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, PT101.
Screenshot source:CDE Official Website
Public information shows that, inIn autoimmune diseases, the immune system inappropriately attacks host cells, targetingRegulatory T cells (Tregs)Enable 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.。

MK-6194Is an engineered IL-2 mutant, to be developed for the treatment ofAutoimmune Diseases。It can 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-concept for the mechanism of action.
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