Shanghai Leadingtac, a rapidly expanding biotechnology company, focusing on the development of protein degrader therapeutics, today announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to conduct a Phase 1 clinical study of LT-002, an IRAK4 protein degrader intended for autoimmune disease such as Hidradenitis Suppurativa and Atopic Dermatitis. LT-002 represents Leadingtac's first investigational degrader targeting autoimmune disease.On 22th April, 2023, Leadingtac has made a Pre-IND meeting request to the CDE of the China National Drug Administration (NMPA), 2023, for a planned submission of IND application on July, 2023. In addition, Leadingtac is expected to submit the application of Phase I trial to Australian Human Research Ethics Committee (HREC) in June, 2023.

“The US IND clearance of our first IRAK4 degrader is a critical milestone for Leadingtac and a key step to compete with global innovations, which transformed Leadingtac from a preclinical stage pharmaceutical company into clinical-stage one.  It also demonstrates successful delivery of Leadingtac’s team execution and the efficiency of our in house R&D platforms.”said Leadingtac’s Chief Executive Officer and founder, Dr Yan Feng. “We would like to thank all the scientists for their years commitment and dedication, the investors for their trust and financial support, and the professionality of CRO partners for their dedicated support. In the future, Leadingtac will continue to work hard with the mission of "Lead the innovation and gather the source, and implement the toughness and openness", and we look forward to bringing more opportunities and benefits for patients based on Leadingtac’s own target protein degradation platforms".

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.

Kymera Therapeutics delivered an oral presentation at the European Academy of Dermatology and Venereology (EADV) symposium in Seville, Spain, May 18-20, 2023. The data showed that KT-474 administered to HS and AD patients had safety, PK and PD similar to healthy volunteers, achieved robust IRAK4 degradation in blood and skin associated with a systemic anti-inflammatory effect, and showed promising clinical activity in HS and AD.

Leadingtac's LT-002 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 is a clinical-stage biopharmaceutical company dediated to the discovery and development of First-in-class/Best-in-class small molecule innovative therapies using 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.