JW Jungwoo Pharmaceutical Applies for Phase 1 Clinical Trial of STAT3-Targeting Anticancer Drug ‘JW2286’

JW Pharmaceutical announced on the 13th that it has submitted an Investigational New Drug (IND) application for the Phase 1 clinical trial of ‘JW2286,’ a solid tumor treatment candidate, to the Ministry of Food and Drug Safety.

This clinical trial will be conducted at Seoul National University Hospital, targeting approximately 60 healthy Korean and Caucasian adults to evaluate the safety, tolerability, and pharmacokinetic properties of JW2286.

JW2286 is a first-in-class innovative drug candidate with a novel mechanism that selectively inhibits STAT3. It is being developed as an oral medication, with indications including triple-negative breast cancer, gastric cancer, and colorectal cancer. STAT3 is a protein that promotes the expression of various genes within cells. Abnormal activation of STAT3 is deeply involved in cancer cell growth, proliferation, metastasis, and drug resistance, and is also known to cause inflammatory diseases such as atopic dermatitis and autoimmune diseases.

JW2286 has demonstrated higher efficacy and safety compared to existing standard therapies in several solid tumors where STAT3 activity serves as a biomarker. These results were confirmed in non-clinical pharmacological evaluations presented by JW Pharmaceutical at the 2021 American Association for Cancer Research (AACR) Annual Meeting. Notably, it showed strong efficacy against triple-negative breast cancer, a type of breast cancer that is not influenced by female hormones or the epidermal growth factor receptor (HER2), and has a very high unmet medical need.

A representative from JW Pharmaceutical stated, “JW2286 is expected to be a drug candidate that selectively and effectively inhibits STAT3, addressing the unmet medical needs of various solid tumors. We will continue to develop it as a global innovative drug through successful clinical trials and open innovation strategies, including technology partnerships.”

JW2286 has completed toxicity evaluations according to non-clinical trial regulations and clinical drug production with research funding support from the National New Drug Development Project.

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