On January 24, 2022 OBI Pharma, a Taiwan biopharma company (TPEx: 4174), reported that the first patients have been enrolled in both of the Phase 2 studies of OBI-999, an antibody drug conjugate (ADC) cancer therapy targeting Globo H, and OBI-3424, a prodrug targeting the enzyme aldo-keto reductase 1C3 (AKR1C3) (Press release, OBI Pharma, JAN 24, 2022, View Source [SID1234606757]).

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The Phase 2 cohort expansion part of the OBI-999-001 (ClinicalTrials.gov Identifier: NCT04084366) entitled "A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients with Advanced Solid Tumors" has now begun enrollment. The Phase 2 part of the study will enroll Globo H expressing patients with pancreatic, colorectal and other high Globo H expression solid tumors in more than ten medical centers in the United States and Taiwan.

The Phase 2 cohort expansion part of the OBI-3424-001 (ClinicalTrials.gov Identifier: NCT03592264) entitled "A Phase 1/2 Study of OBI-3424 in Subjects with Advanced Solid Tumors" has also begun enrollment. This study will enroll AKR1C3 expressing patients with pancreatic and other high AKR1C3 expressing solid tumors in select oncology medical centers in the United States.

OBI’s Chairman and Chief Executive Officer, Michael Chang, PhD, noted "OBI Pharma strives to develop novel therapeutics for cancer patients worldwide. Based upon the impressive Phase 1 safety study and preclinical data of OBI-999 and OBI-3424, we are excited to commence our Phase 2 efficacy and safety study in patients with high Globo H or AKR1C3 antigen expression in solid tumors. We would like to thank the commitment of our international investigators to bring these 1st-in-class cancer therapeutic products to potential patients in our ongoing study."

OBI anticipates completing the enrollment of both Phase 2 studies in the second half of 2023.

About OBI-999

OBI-999 is a novel first-in-class Antibody Drug Conjugate (ADC) with a proprietary linker technology that provides a consistent Drug-to-Antibody ratio (DAR) for cancer treatment that is based on Globo H, an antigen expressed in up to 15 epithelial cancers. OBI-999 uses a Globo H antibody to target cancer cells of high Globo H expression. By releasing a small molecule chemotherapeutic drug through the specificity of the antibody, it directly deploys cytotoxic therapy at the targeted cancer cells. In pre-clinical xenograft animal models in multiple tumor types (gastric, pancreatic, lung and breast), OBI-999 has demonstrated profound tumor shrinkage at various doses. In human Phase 1 study, OBI-999 was well-tolerated, and achieved a favorable safety margin which warrants further clinical development. OBI-999 is currently in a Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04084366) in medical centers in the US and Taiwan. OBI Pharma owns global rights to OBI-999.

About OBI-3424

OBI-3424 is a first-in-class novel small-molecule prodrug that 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 (HCC), castrate-resistant prostate cancer (CRPC), 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-3424 is currently in a Phase 2 trial (ClinicalTrials.gov Identifier: NCT03592264) in medical centers in the US. OBI owns global rights to OBI-3424 except the Asia Pacific region.