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OBI Pharma Announces Acquisition of TH-3424 from Threshold Pharmaceuticals

01 Jun 17

OBI Pharma, Inc., a Taiwan biopharma company (TPex: 4174), announced today an agreement with Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) to acquire TH-3424, a first-in-class novel small-molecule prodrug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1c3 (AKR1C3). The product will be renamed OBI-3424 effective immediately.

OBI-3424 is a first-in-class prodrug that 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. For example, hepatocellular carcinomas (HCC), which highly overexpress AKR1C3 in the majority of patients. OBI-3424 has demonstrated potent activities in preclinical models of HCC, including a model resistant to the standard of care treatment, sorafenib. AKR1C3 is adaptively upregulated in response to castration; therefore, castrate-resistant prostate cancer is another logical unmet need population where OBI-3424 will be tested. In addition, the US National Cancer Institute is performing preclinical evaluations of OBI-3424 for the potential treatment of T-cell acute lymphoblastic leukemia (T-ALL).

Furthermore, individualized patient selection by staining for AKR1C3 overexpression by immunohistochemistry can be performed to identify patients with other tumor types most likely to respond to treatment with OBI-3424, thereby offering the possibility for a streamlined clinical development strategy.

Under the terms of the agreement, Threshold will transfer to OBI Pharma its ownership rights as well as preclinical and manufacturing data for OBI-3424 in exchange for an undisclosed, upfront one-time payment. No further payments or future royalties are required. OBI Pharma will obtain Threshold's global intellectual property as well as the commercial, developmental, and manufacturing rights to OBI-3424, except in certain specified countries in Asia (see footnote 1).

"OBI-3424 is an innovative anticancer drug that can preferentially deliver its payload to cancers that overexpress the activating enzyme, AKR1C3. AKR1C3 is highly overexpressed in a number of cancers that represent unmet medical needs, including hepatocellular carcinoma, castrate-resistant prostate cancer, and T-cell acute lymphoblastic leukemia. OBI-3424 offers the possibility of early efficacy read outs based on objective response rates in well-defined resistant patient populations," said Tillman Pearce, M.D., Threshold's Chief Medical Officer.

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