On March 28, 2023, Shanghai Leadingtac Pharmaceutical Co., Ltd. (hereinafter referred to as "Leadingtac Biotech") announced that it has officially submitted an IND clinical trial application to the U.S. FDA for its first IRAK4 novel protein degrader, and plan to file an IND simultaneously in China and Australia in Q2 2023 for the following indications Hidradenitis Suppurativa (HS) and Atopic Dermatitis (AD). In February 2023, Leadingtac already established the communication with US FDA in a Pre-IND meeting.

Based on publicly available information, in 2020 Sanofi acquires an autoimmune field interest in the Kymera IRAK4 program for an upfront payment of $150 million and $2 billion in potential development, regulatory and sales milestones, as well as significant royalty payments. On March 20, 2023, Gilead announced its exclusive rights to Nurix’s IRAK4 degrader, NX-0479, in exchange for $20 million in upfront cash and with $425 million in milestone payment. It’s the first target that Gilead has signed onto stemming from a June 2019 agreement with Nurix, with Gilead offering up to $2.35 billion in exchange for five protein degrader targets. (This information comes from "Smurf One" and "Pharma Notes" respectively)

About IRAK4 degraders:

IRAK4 (interleukin-1 receptor-associated kinase 4) is one of the human IRAK kinase family isozymes that plays a pivotal role in protein phosphorylation as well as in cellular signaling. It receives signals from the upstream toll-like receptors (TLRs) and the interleukin-1 receptor family (IL-1R) and activates the downstream NF-κB and JNK signaling pathways, which are important for human inflammatory responses and tumors. In December 2022, Kymera announced the phase 1 clinical data of its IRAK4 degrader KT-474, which demonstrated good efficacy in HS and AD patients.

Leadingtac's LT-002-158 is the first IRAK4 protein degrader in China and the second in the world to submit an IND application to the FDA following Kymera's KT-474. The molecule is developed on Nano-SPUD®, a target protein degradation drug development platform of Leadingtac. In preclinical animal models, the compound showed superior efficacy in improving skin inflammation symptoms and a favorable safety profile.

About Leadingtac

Founded in 2019, Leadingtac Bio is a biopharmaceutical company dedicated to the development of First-in-class/Best-in-class small molecule innovative drugs, with Targeted Protein Degradation (TPD) drug development platform with a focus on autoimmune and oncology, two therapeutic areas with great clinical unmet needs: autoimmune disease and oncology, providing breakthrough therapeutic solutions for patients. Located in Zhangjiang Science City, Shanghai, China, Leadingtac has nearly 1000 square meters of laboratory and office space, 20 employees, and has raised nearly CNY￥100 million in funding since its inception 3 years ago.