Idians Announces Interim Results of Phase 1 Clinical Trial of 'Benadaparib' at American Gastroenterological Association Meeting
Idians, a new drug development company under Ildong Pharmaceutical Group, announced on the 22nd that it presented research results related to its drug candidate 'Venadafarib' at the 'ASCO GI 2024,' a gastrointestinal cancer symposium held from the 18th to the 20th (local time) at the American Society of Clinical Oncology (ASCO).
Venadafarib is a targeted anticancer drug candidate that inhibits 'poly (ADP-ribose) polymerase (PARP).' PARP is a protein known to repair DNA damage in the nucleus of cells. Therefore, inhibiting PARP suppresses the repair of DNA damage in cancer cells, leading to their death. Idians is currently advancing clinical development targeting gastric cancer, breast cancer, ovarian cancer, and PARP inhibitor-resistant cancers.
At this symposium, Idians disclosed interim results of a Phase 1 clinical trial in a poster presentation format, investigating the combination therapy of Venadafarib and the chemotherapy drug 'Irinotecan' in patients receiving third- or fourth-line treatment for gastric cancer.
According to the presentation, the optimal dose combination of Venadafarib and Irinotecan was explored, and among the evaluable patient group (11 patients) receiving the combination therapy, the objective response rate (ORR) was 36.4%, and the median progression-free survival (mPFS) was 5.6 months. Additionally, among five gastric cancer patients with homologous recombination deficiency (HRD), a biomarker for anticancer treatment, the ORR was relatively high at 60%. ORR refers to the proportion of patients showing a significant reduction in tumor size, and mPFS indicates the median duration during which the cancer does not progress and the patient survives.
Idians explained that considering the ORR and mPFS of 'Lonsurf (trifluridine/tipiracil),' currently used as the third-line standard treatment for metastatic gastric cancer, were 4% and 2.0 months respectively in Phase 3 clinical trials, the clinical results of Venadafarib are encouraging. They also added that the results are meaningful as they were obtained under conditions including both HER2-positive and HER2-negative gastric cancer patients, classified based on the presence or absence of human epidermal growth factor receptor 2 (HER2) in gastric cancer.
An Idians representative stated, “The combination therapy of Venadafarib showed higher ORR and mPFS compared to existing standard treatments, as well as efficacy in HRD gastric cancer and both HER2-positive and HER2-negative gastric cancers, suggesting it could be a promising treatment option with a broader scope of application.”
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The company plans to accelerate the development of Venadafarib aiming to enter Phase 2 and 3 pivotal clinical trials next year.
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