Research & Development
FDA Grants OBI Pharma Clearance of OBI-3424 IND Application for Phase I/II Study Targeting AKR1C3 Solid Tumors
23 April 2018 - - Taipei, Taiwan-based biopharma company OBI Pharma, Inc. (TPEx: 4174) has received clearance from the US Food and Drug Administration for an investigational new drug application for a Phase I/II study of OBI-3424, a first-in-class DNA alkylating agent that targets cancers that overexpress the aldo-keto reductase 1C3 (AKR1C3) enzyme, the company said.
OBI plans to enroll patients with local solid tumors, including hepatocellular carcinoma and castrate-resistant prostate cancer.
OBI-3424, first-in-class novel small-molecule prodrug, selectively targets cancers overexpressing the enzyme aldo-keto reductase 1C3 (AKR1C3), and selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme.
This selective mode of activation distinguishes OBI-3424 from traditional alkylating agents, such as cyclophosphamide and ifosfamide, which are non-selective.
AKR1C3 overexpression has been documented in a number of treatment-resistant and difficult-to-treat cancers including: hepatocellular carcinomas, castrate-resistant prostate cancer, and T-cell acute lymphoblastic leukemia (T-ALL). AKR1C3 is highly expressed in up to 15 solid and liquid tumors.
Furthermore, individualized patient selection by staining for AKR1C3 overexpression by immunohistochemistry can be performed based on tumor biopsies or circulating tumor cells to identify patients with other tumor types most likely to respond to treatment with OBI-3424, and thus offering the possibility for a streamlined clinical development strategy.
OBI Pharma's mission is to develop and license novel therapeutic agents for unmet medical needs against cancer targets.
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