1.Date of occurrence of the event:2024/03/11
2.Company name: OBI Pharma, Inc.
3.Relationship to the Company (please enter ”head office” or ”subsidiaries”):head office
4.Reciprocal shareholding ratios: NA
5.Cause of occurrence: Following a strategic portfolio review, the Company’s
Board of Directors has 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.
(2)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.
(3)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 NT$300 million
will be shifted to support other priority projects after OBI-3424-001
trial is terminated.
(4)The Company will continue the development of OBI-3424 in hematological
malignancies through collaboration with Southwest Oncology Group
(hereinafter referred to as “SWOG”), 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
lymphocytic leukemia in China.
6.Countermeasures: 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.
7.Any other matters that need to be specified(the information
disclosure also meets the requirements of Article 7, subparagraph 9
of the Securities and Exchange Act Enforcement Rules, which brings
forth a significant impact on shareholders rights or the price of
the securities on public companies.): NA