Following a strategic portfolio review, the Board of Directors of OBI Pharma, Inc. (4174) has decided to terminate the OBI-3424-001 trial today (March 11, 2024), while continuing the collaboration of OBI-3424 with partners, given that the OBI-3424 development is still ongoing.
Dr. Heidi Wang, the Chief Executive Officer of OBI Pharma, emphasized that this decision was made to allocate limited resources to other priority projects. Other than OBI-3424-001 Phase II study, there is an ongoing Phase I/II clinical trial sponsored by the Southwest Oncology Group (hereinafter referred to as “SWOG”), recruiting patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T-cell lymphoblastic lymphoma (T-LBL). This clinical trial led by SWOG is currently open for enrollment in several medical institutions in the U.S., and OBI will continue to support the drug supply for this trial. In the meantime, the collaboration with Ascentawits Pharmaceuticals, Ltd. also continues. Ascentawits is conducting clinical trials in patients with hepatocellular carcinoma (HCC) and acute lymphoblastic leukemia (ALL) in China.
Dr. Ming-Tain Lai, the Chief Scientific Officer of OBI Pharma, pointed out that OBI-3424 Phase I clinical trial results demonstrated good tolerability and no major safety concerns. OBI-3424-001 Phase II clinical trial on patients with advanced solid tumors has been opened for enrollment in several medical institutions in the U.S. since 2021. Since then, a total of 29 advanced solid tumor patients have been treated, including patients with colorectal, pancreatic, and other cancer types. However, OBI-3424 has not demonstrated therapeutic potentials in these cancer patients. After careful assessment, the Company decided to terminate OBI-3424-001 trial. An estimated NT$300 million (or US~$10 million) will be shifted to support other priority projects after OBI-3424-001 trial is terminated.
The Phase II clinical trial of OBI-3424-001 was originally intended to enroll 62 patients. The Company will continue to provide medical care to patients still on study in accordance with the clinical study protocol and will manage the unused investigational products in compliance with related regulations and the Good Clinical Practice.
OBI-3424 is a first-in-class novel chemotherapeutic prodrug that is selectively converted by AKR1C3 to a potent DNA-alkylating agent that leads to selective killing of cancer cells. The Company acquired the worldwide right (except for China, Hong Kong, Macao, Taiwan, Japan, South Korea, Singapore, Malaysia, Thailand, Turkey, and India) of OBI-3424 from Threshold Pharmaceuticals, Inc. in 2017. OBI-3424 has been granted Orphan Drug Designation for the treatment of HCC and ALL by the US FDA in 2018.
The Company also continues the collaboration with Ascentawits Pharmaceuticals, Ltd., who owns the OBI-3424 right in China, Hong Kong, Macao, Taiwan, Japan, South Korea, Singapore, Malaysia, Thailand, Turkey, and India, through the sharing of clinical data and information.