OBI Pharma, Inc. announced that Board of Directors decided to terminate the OBI-3424-001 trial, and to allocate resources to other priority projects. (1)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 acute lymphocytic leukemia (ALL) and hepatocellular carcinoma (HCC) by FDA in 2018. The Company has completed the Phase I clinical trial of OBI-3424, the result demonstrated good tolerability and no major safety concerns. The Phase II clinical trial of OBI-3424-001 on patients with advanced solid tumors has been opened for enrollment in several medical institutions in the U.S. since 2021.

However, OBI-3424 has shown only limited therapeutic potential in advanced solid tumor patients in this trial during the past two plus years. As such, the Company has made a decision to terminate this Phase II trial and will allocate resources to other priority projects. The Company will continue to provide medical care to the enrolled patients in accordance with the clinical study protocol and will manage the unused investigational products in compliance with related regulations and the Good Clinical Practice.

An estimated TWD 300 million will be shifted to support other priority projects after OBI-3424-001 trial is terminated. The Company will continue the development of OBI-3424 in hematological malignancies through collaboration with Southwest Oncology Group, an institute sponsored by the National Cancer Institute (NCI). The Company is responsible for providing investigational products and related assistance to support the SWOG Phase I/II clinical trials enrolling 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. The Company also collaborates with Ascentawits Pharmaceuticals Ltd., who owns the right in China, Hong Kong, Macao, Taiwan, Japan, South Korea, Singapore, Malaysia, Thailand, Turkey, and India, through the sharing of clinical data and information. Ascentawits Pharmaceuticals Ltd. now conducts the Phase I/II clinical trials enrolling patients with hepatocellular carcinoma and acute ymphocytic leukemia in China. Counter measures: Following a strategic portfolio review, the Company has decided to terminate the OBI-3424-001 Phase II trial based on the clinical response assessment in advanced solid tumor subjects.

Meanwhile, the Company will continue limited clinical development of OBI-3424 through external partnerships. Further development strategy will be determined based on the relevant clinical data provided through external partnerships.