First clinical trial to evaluate the safety and efficacy of OBI-3424, a DNA alkylating agent targeting AKR1C3 enzyme, in T-Cell Acute Lymphocytic Leukemia (T-ALL) and Lymphoblastic Lymphoma (T-LBL)
TAIPEI, Taiwan, April 26, 2021 — OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced that the U.S.-based SWOG Cancer Research Network has started patient enrollment for a Phase I/II study of OBI-3424, a first-in-class (small-molecule prodrug) DNA alkylating agent that targets cancers expressing the aldo-keto reductase 1C3 (AKR1C3) enzyme.
The study, S1905 (ClinicalTrials.gov Identifier: NCT04315324), is titled “A Phase 1/2 Study of AKR1C3-Activated Prodrug OBI-3424 in Patients with Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)/T-Cell Lymphoblastic Lymphoma (T-LBL).” SWOG is a member of the National Cancer Institute’s (NCI) National Clinical Trials Network (NCTN), America’s largest publicly funded cancer research network. In the NCTN, cancer trials are designed by some of the nation’s leading cancer experts, funded by tax dollars, and powered by patient volunteers.
OBI Pharma’s Chief Medical Officer, Tillman Pearce, M.D., noted, “this clinical trial intends to verify whether the potent efficacy that OBI-3424 demonstrated against T-ALL patient-derived xenografts in mice (Evans et al. Clin Ca Res 2019) can be observed in T-ALL and T-LBL patients. The initial xenograft experiments were conducted by the NCI Pediatric Preclinical Study Group, so it is very fitting that SWOG is the first to evaluate the concept in patients. This study in an unmet population of patients with T cell acute leukemias and lymphomas is complementary to OBI Pharma’s ongoing phase 1/2 study evaluating OBI-3424 in solid tumors (ClinicalTrials.gov Identifier: NCT03592264).”
Anjali S. Advani, MD, director of the Inpatient Leukemia Unit at Cleveland Clinic Taussig Cancer Institute and professor of medicine at Cleveland Clinic Lerner College of Medicine in Cleveland, OH is the lead investigator of the OBI-3424 T-ALL/T-LBL SWOG trial.
“Although the treatments in B-ALL have advanced significantly, we have lagged behind in T-ALL,” said Dr. Advani. “We are hopeful that targeting AKR1C3 in T-ALL will represent a promising treatment strategy.”
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.
About SWOG Cancer Research Network
SWOG Cancer Research Network is part of the National Cancer Institute’s National Clinical Trials Network and the NCI Community Oncology Research Program, and is part of the oldest and largest publicly-funded cancer research network in the nation. SWOG has nearly 12,000 members in 47 states and eight other countries who design and conduct clinical trials to improve the lives of people with cancer. SWOG trials have led to the approval of 14 cancer drugs, changed more than 100 standards of cancer care, and saved more than 3 million years of human life. Learn more at swog.org.
About T-ALL and T-LBL
The treatment of relapsed/refractory T‐cell acute lymphoblastic leukemia (T-ALL) remains an unmet need. Once ALL relapses in adults, the prognosis is poor (7% overall survival at 5 years) and novel therapies are needed. Ultimately, the only known cure is allogeneic hematopoietic stem cell transplant. However, patients typically need to be in remission to proceed to allogeneic transplant. There have been significant advances in the field of relapsed/refractory B‐Cell Acute Lymphoblastic Leukemia over the last 5 years. Patients with relapsed or refractory T-LBL have dismal outcomes and may receive similar treatments to relapsed or refractory T-ALL patients.
About OBI Pharma
OBI Pharma, Inc., is a Taiwan biopharmaceutical company that was established in 2002. Its mission is to develop and license novel therapeutic agents for unmet medical needs against cancer targets such as Globo Series (including Globo H, SSEA-3 and SSEA-4), AKR1C3, and other promising targets.
The company’s novel first-in-class immuno-oncology portfolio against Globo H includes: Adagloxad Simolenin (formerly OBI-822) and OBI-833, a Globo H active immunotherapy vaccine; OBI-888 (Globo H mAb) and OBI-999 (Globo H ADC). The company’s novel first-in-class AKR1C3 targeted therapy is OBI-3424 (small-molecule prodrug) that selectively releases a potent DNA alkylating agent in the presence of the aldo-keto reductase 1C3 (AKR1C3) enzyme. Additional information can be found at www.obipharma.com.
Statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about future clinical trials, results and the timing of such trials and results. Such risk factors are identified and discussed from time to time in OBI Pharma’s reports and presentations, including OBI Pharma’s filings with the Taiwan Securities and Futures Bureau.
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