TAIPEI, Taiwan, June 1, 2017 /PRNewswire/ -- OBI Pharma, Inc., a
Taiwan biopharma company (TPex:
4174), announced today an agreement with Threshold Pharmaceuticals,
Inc. (NASDAQ: THLD) to acquire TH-3424, a first-in-class novel
small-molecule prodrug that selectively targets cancers
overexpressing the enzyme aldo-keto reductase 1c3 (AKR1C3). The
product will be renamed OBI-3424 effective immediately.
OBI-3424 is a first-in-class prodrug that 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. For example,
hepatocellular carcinomas (HCC), which highly overexpress AKR1C3 in
the majority of patients. OBI-3424 has demonstrated potent
activities in preclinical models of HCC, including a model
resistant to the standard of care treatment, sorafenib. AKR1C3 is
adaptively upregulated in response to castration; therefore,
castrate-resistant prostate cancer is another logical unmet need
population where OBI-3424 will be tested. In addition, the US
National Cancer Institute is performing preclinical evaluations of
OBI-3424 for the potential treatment of T-cell acute lymphoblastic
leukemia (T-ALL).
Furthermore, individualized patient selection by staining for
AKR1C3 overexpression by immunohistochemistry can be performed to
identify patients with other tumor types most likely to respond to
treatment with OBI-3424, thereby offering the possibility for a
streamlined clinical development strategy.
Under the terms of the agreement, Threshold will transfer to OBI
Pharma its ownership rights as well as preclinical and
manufacturing data for OBI-3424 in exchange for an undisclosed,
upfront one-time payment. No further payments or future royalties
are required. OBI Pharma will obtain Threshold's global
intellectual property as well as the commercial, developmental, and
manufacturing rights to OBI-3424, except in certain specified
countries in Asia (see footnote
1).
"OBI-3424 is an innovative anticancer drug that can
preferentially deliver its payload to cancers that overexpress the
activating enzyme, AKR1C3. AKR1C3 is highly overexpressed in a
number of cancers that represent unmet medical needs, including
hepatocellular carcinoma, castrate-resistant prostate cancer, and
T-cell acute lymphoblastic leukemia. OBI-3424 offers the
possibility of early efficacy read outs based on objective response
rates in well-defined resistant patient populations," said
Tillman Pearce, M.D., Threshold's
Chief Medical Officer.
"We will continue the pre-clinical work and hope that OBI-3424
develops into a solid treatment option for patients with cancers
that express AKR1C3," said Amy
Huang, General Manager of OBI Pharma, Inc. "This novel
cancer therapeutic enhances our pipeline and moves us another step
towards becoming a global cancer biopharma company. "
OBI Pharma plans to accelerate the development of OBI-3424, with
an Investigational New Drug (IND) application filing with the U.S.
Food and Drug Administration (FDA) planned for early 2018.
(1) OBI obtains worldwide rights with the exception of the
following countries: China,
Hong Kong, Macao, Taiwan, Japan, South
Korea, Singapore,
Malaysia, Thailand, Turkey and India.
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, including cancer
targets such as the Globo series antigens, AKR1C3 and other
promising targets. The company's flagship product is Adagloxad
Simolenin (formerly OBI-822), a first-in-class active
immunotherapy for metastatic breast cancer. OBI is also developing
next generation immunotherapies for difficult to treat cancers,
including lung, colorectal, pancreatic, gastric, and ovarian
cancer. Additional information can be found at
www.obipharma.com/en.
Forward-Looking Statements
Statements included in
this press release that are not a description of historical facts
are forward-looking statements within the meaning of the US 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.
COMPANY CONTACT:
Gus Adapon
OBI Pharma, Inc.
+886 (2) 2786-6589
info@obipharma.com
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SOURCE OBI Pharma, Inc.