Taiwan's OBI Pharma, Inc. announced on the 11th that its board of directors has approved a resolution to halt enrollment in the Phase II clinical trial of its anti-cancer drug OBI-3424. However, OBI Pharma emphasized that the development plan for OBI-3424 has not been entirely terminated, and collaboration with other partners in clinical trials will continue.
OBI Pharma's CEO, Dr. Heidi Wang, stressed that the purpose of this decision is to focus limited resources on key products to accelerate the development progress. She pointed out that in addition to the Phase II physical tumor clinical trial of OBI-3424, which is about to be halted, the first/second phase clinical trial project for T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) led by the Southwest Oncology Group (SWOG) in the United States is still actively enrolling participants.
This project is sponsored by the National Cancer Institute (NCI), with OBI Pharma providing OBI-3424 trial drugs and assisting in related operations. OBI Pharma is also collaborating with Shenzhen Ascentawits Pharmaceuticals, Ltd. to conduct clinical trials of OBI-3424 for the treatment of hepatocellular carcinoma and acute lymphoblastic leukemia in mainland China.
OBI Pharma's Chief Research Officer, Dr. Ming-Tain Lai, pointed out that the Phase I clinical trial of OBI-3424 has demonstrated good safety and tolerability. However, over the past two years, the Phase II human clinical trial of OBI-3424 for patients with progressive solid tumors has treated 29 tumor patients, including colorectal cancer, pancreatic cancer, and other solid tumor patients, but has not demonstrated its therapeutic potential for these cancers. After careful evaluation, the company decided to halt the OBI-3424-001 trial project and focus the saved approximately NT$300 million on other development projects.
The original plan for the OBI-3424 Phase II clinical trial was to enroll 62 patients. OBI Pharma emphasized that after the trial enrollment was halted prematurely, appropriate care will still be provided to the trial patients according to the clinical trial protocol, and the trial drugs will be handled in accordance with relevant regulations and Good Clinical Practice (GCP) guidelines.
OBI Pharma explained that OBI-3424 is a first-in-class prodrug small molecule drug that selectively releases potent DNA alkylating agents to cancer cells overexpressing aldo-keto reductase 1C3 (AKR1C3) to achieve anti-cancer effects. In 2017, OBI Pharma was granted the global development rights to OBI-3424 outside of China, Hong Kong, Macau, Taiwan, Japan, South Korea, Singapore, Malaysia, Thailand, Turkey, and India by California-based Threshold Pharmaceuticals. OBI-3424 received orphan drug designation from the U.S. Food and Drug Administration (FDA) in 2018 for the treatment of acute lymphoblastic leukemia (ALL) and hepatocellular carcinoma (HCC).
Shenzhen Ascentawits Pharmaceuticals holds the development rights to OBI-3424 in China, Hong Kong, Macau, Taiwan, Japan, South Korea, Singapore, Malaysia, Thailand, Turkey, and India. Additionally, both parties share relevant trial data and information according to the agreement.
