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- -STAT3 Inhibitor JW2286 Developed as a First-in-Class Global Innovative Drug
- -Expected to Address Unmet Medical Needs in Various Solid Tumors
- -Progression to Clinical Phase with In-House R&D Platform Targeting Wnt and STAT
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June 2024
JW Pharmaceutical announced on the 19th that it has received approval from the Ministry of Food and Drug Safety for the clinical phase 1 IND for its STAT3 inhibitor 'JW2286', which is being developed as a treatment for solid tumors.
JW2286 is a novel mechanism-based first-in-class candidate that selectively inhibits STAT3. It is being developed as an oral drug, targeting triple-negative breast cancer, gastric cancer, and colorectal cancer.
This clinical trial aims to evaluate the safety, tolerability, and pharmacokinetic properties of JW2286 in approximately 70 healthy Korean and Caucasian adults at Seoul National University Hospital.
STAT3 is a protein (transcription factor) that promotes the expression of various genes within cells. Abnormal activation of STAT3 is deeply involved in the growth, proliferation, metastasis, and drug resistance of cancer cells, and it is also known to cause inflammatory diseases and autoimmune disorders such as atopic dermatitis.
According to preclinical pharmacological evaluation results presented by JW Pharmaceutical at the 2021 American Association for Cancer Research (AACR) Annual Meeting, JW2286 demonstrated higher efficacy and safety compared to standard therapies in several solid tumors with high STAT3 activity as a biomarker, showing particularly strong efficacy in triple-negative breast cancer. Triple-negative breast cancer is a type of breast cancer that is not affected by female hormones or epidermal growth factor (HER2), with very high unmet medical needs.
A JW Pharmaceutical representative stated, "The IND approval is a significant milestone in the development of JW2286, recognizing its potential to address unmet medical needs in oncology and immunological disorders. We will continue to develop JW2286 as the first innovative drug that selectively inhibits STAT3."
JW2286 was selected as a supported project in the '2022 2nd National New Drug Development Project'. With funding from the National New Drug Development Project, JW Pharmaceutical completed the GLP (Good Laboratory Practice) toxicity evaluation and production of the clinical drug for JW2286.
About STAT and JW Research
The JAK-STAT pathway is a representative intracellular signal transduction system involved in cell development, differentiation, growth, survival, and various immune responses. STAT proteins consist of seven different types (STAT1~4, STAT5A, STAT5B, STAT6) with distinct functions, activated by the upstream protein JAK. While the JAK-STAT pathway is typically controlled within a normal range, abnormal activation (overexpression or hyperactivation) of the proteins can lead to various diseases.
Pharmaceutical companies, including global big pharma, are focusing on developing treatments for immune and tumor diseases by targeting JAK to inhibit the JAK-STAT signaling pathway. However, to date, no new drugs have been developed globally that directly inhibit STAT.
JW Pharmaceutical is developing specific small molecule inhibitors that directly bind to and inhibit the activity of STAT3, STAT5, STAT6, aiming to achieve powerful effects and overcome the side effect issues of JAK inhibitors. JW Pharmaceutical's subsidiary, C&C New Drug Research Institute, is focused on discovering new drugs targeting STAT proteins, currently securing a pipeline of over 10 new drug candidates for tumor and immune disorders. C&C's new drug pipeline has been continuously recognized as a national project. In addition to the preclinical research on the STAT3-targeted anticancer drug JW2286 (2022), the optimization research for the lead compound of the STAT3-targeted atopic dermatitis treatment (2021), and the optimization research for the lead compound of the STAT5/STAT3 dual-targeted acute myeloid leukemia treatment (2023) were each selected as national projects.
About AI and Data Science Platform-Based Innovative Drug Development Targeting Wnt and STAT
JW Pharmaceutical is continuously generating new drug candidates in oncology, immunological diseases, and regenerative medicine by leveraging its in-house data science platforms 'JWELRY' and 'CLOVER', targeting Wnt and STAT. Recently, JW has been enhancing and differentiating its R&D platform by integrating AI (artificial intelligence) and deep learning technology with chemical and biological informatics big data and actively pursuing open innovation with external AIDD (AI-based Discovery) platforms.
JW's new drug research center is utilizing 'JWELRY (JW Excellent LibraRY)', specialized in the Wnt signaling pathway, as a core technology. JWELRY is based on a library of tens of thousands of compounds involved in the Wnt pathway and drug evaluation and mechanism research technologies that distinguish inhibition and activation of the Wnt pathway.
CLOVER (C&C Research Laboratories Omics serVER) is the R&D platform of C&C New Drug Research Institute, a research subsidiary of JW Pharmaceutical, actively engaged in developing new drugs targeting STAT proteins. JW is accelerating the development of its new drug pipeline targeting Wnt or STAT, with plans to initiate clinical trials for the Wnt-targeted hair loss treatment 'JW0061' and the STAT3-targeted anticancer drug 'JW2286' in 2024.
Additionally, JW is continuously striving to enhance translational research to reduce the gap between preclinical and clinical stages and increase the likelihood of clinical success by integrating R&D platforms such as AI, organoids, and zebrafish (open innovation).