− ONO Rights Include Oncology Indications for
Selinexor and KPT-8602 in Japan, South Korea, Taiwan, Hong Kong and
ASEAN countries –
Karyopharm Therapeutics Inc. (Nasdaq:KPTI) (Karyopharm) and Ono
Pharmaceutical Co., Ltd. (ONO), today announced their entry into an
exclusive license agreement for the development and
commercialization of selinexor, Karyopharm’s lead, novel, oral
Selective Inhibitor of Nuclear Export (SINE™) compound, and
KPT-8602, Karyopharm’s second-generation oral SINE™ compound.
The agreement includes the development of selinexor and KPT-8602
for the diagnosis, treatment and/or prevention of all human
oncology indications in Japan, South Korea, Taiwan, Hong Kong, and
ASEAN countries (the Territory).
Under the terms of the agreement, Karyopharm
will receive a one-time upfront payment of ¥2.5 billion
(approximately US$22.3 million) from ONO and retains all rights to
selinexor and KPT-8602 outside the Territory. Karyopharm is
eligible to receive up to an additional ¥19.15 billion
(approximately US$170.7 million at the current exchange rate) if
specified future development and commercial milestones are achieved
by ONO. Karyopharm is also eligible to receive low
double-digit royalties based on future net sales of selinexor and
KPT-8602 in the Territory. In exchange, ONO will receive
exclusive rights to develop and commercialize both compounds in the
Territory, at its own cost and expense. ONO will also have
the ability to participate in any global clinical study of
selinexor and KPT-8602, and will bear the cost and expense for
patients enrolled in clinical studies in the Territory.
“We are very delighted to collaborate on the
development of selinexor and KPT-8602, an early development stage
XPO-1 inhibitor with Karyopharm, a leading pharmaceutical company
focused on the research and development of novel first-in-class
drugs in the oncology field,” said Gyo Sagara, President,
Representative Director of ONO. “We believe both products
will present a new treatment option to patients suffering from
devastating cancers in Asian countries.”
“Given ONO’s established leadership in oncology,
including Opdivo® (nivolumab) and Kyprolis® (carfilzomib) in Japan,
we believe there is no company better suited to advance both
selinexor and KPT-8602 in Japan and the other licensed
territories,” said Michael G. Kauffman, MD, PhD, Chief Executive
Officer of Karyopharm. “ONO is well-known and widely
respected for its clinical development and commercial expertise,
and this partnership provides important validation for both
compounds, while allowing us to remain focused on executing our
late-phase selinexor trials and pursue regulatory approval in the
United States and European Union. We look forward to working
with the ONO team to advance both compounds with the goal of
rapidly bringing them to patients who are in need of new treatment
options.”
About Selinexor
Selinexor (KPT-330) is a first-in-class, oral
Selective Inhibitor of Nuclear Export / SINE™ compound. Selinexor
functions by binding with and inhibiting the nuclear export protein
XPO1 (also called CRM1), leading to the accumulation of tumor
suppressor proteins in the cell nucleus. This reinitiates and
amplifies their tumor suppressor function and is believed to lead
to the selective induction of apoptosis in cancer cells, while
largely sparing normal cells. To date, over 2,200 patients have
been treated with selinexor, and it is currently being evaluated in
several mid- and later-phase clinical trials across multiple cancer
indications, including in multiple myeloma in a pivotal, randomized
Phase 3 study in combination with Velcade® (bortezomib) and
low-dose dexamethasone (BOSTON), in combination with low-dose
dexamethasone (STORM) and backbone therapies (STOMP), and in
diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL),
among others. Additional Phase 1, Phase 2 and Phase 3 studies are
ongoing or currently planned, including multiple studies in
combination with one or more approved therapies in a variety of
tumor types to further inform Karyopharm's clinical development
priorities for selinexor. Additional clinical trial information for
selinexor is available at www.clinicaltrials.gov.
About KPT-8602
KPT-8602 is a second generation oral SINE™
compound. KPT-8602 functions by binding to and inhibiting the
nuclear export protein XPO1 (also called CRM1), leading to the
accumulation of tumor suppressor proteins in the cell
nucleus. KPT-8602 has demonstrated minimal brain penetration
in animals, which has been associated with reduced toxicities in
preclinical studies while maintaining potent anti-tumor
effects.
About Karyopharm
Therapeutics
Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a
clinical-stage pharmaceutical company focused on the discovery and
development of novel first-in-class drugs directed against nuclear
transport and related targets for the treatment of cancer and other
major diseases. Karyopharm's SINE™ compounds function by binding
with and inhibiting the nuclear export protein XPO1 (or CRM1). In
addition to single-agent and combination activity against a variety
of human cancers, SINE™ compounds have also shown biological
activity in models of neurodegeneration, inflammation, autoimmune
disease, certain viruses and wound-healing. Karyopharm, which was
founded by Dr. Sharon Shacham, currently has several
investigational programs in clinical or preclinical development.
For more information, please visit www.karyopharm.com.
About Ono Pharmaceutical Co.,
Ltd.
Ono Pharmaceutical Co., Ltd., headquartered in
Osaka, Japan, is an R&D-oriented pharmaceutical company
committed to creating innovative medicines in specific areas. It
focuses especially on the diabetes and oncology areas. For more
information, please visit the company's website at
http://www.ono.co.jp/eng/index.html.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include those
regarding the potential to receive milestone and royalty payments
under the license agreement with ONO; the success of Karyopharm’s
arrangement with ONO and the parties’ ability to work effectively
together; and the therapeutic potential of and potential clinical
development plans for Karyopharm's drug candidates. Such statements
are subject to numerous important factors, risks and uncertainties
that may cause actual events or results to differ materially from
Karyopharm’s current expectations. For example, there can be no
guarantee that any of Karyopharm's SINE™ compounds, including
selinexor (KPT-330), will successfully complete necessary
preclinical and clinical development phases or that development of
any of Karyopharm's drug candidates will continue. Further, there
can be no guarantee that any positive developments in Karyopharm's
drug candidate portfolio will result in stock price appreciation.
Management's expectations and, therefore, any forward-looking
statements in this press release could also be affected by risks
and uncertainties relating to a number of other factors, including
the following: the ability of Karyopharm or ONO to fully perform
their respective obligations under the license agreement;
Karyopharm's results of clinical trials and preclinical studies,
including subsequent analysis of existing data and new data
received from ongoing and future studies; the impact volatility in
currency exchange rates, the content and timing of decisions made
by the U.S. Food and Drug Administration and other regulatory
authorities, investigational review boards at clinical trial sites
and publication review bodies, including with respect to the need
for additional clinical studies; Karyopharm's ability to obtain and
maintain requisite regulatory approvals and to enroll patients in
its clinical trials; unplanned cash requirements and expenditures;
development of drug candidates by Karyopharm's competitors for
diseases in which Karyopharm is currently developing its drug
candidates; and Karyopharm's ability to obtain, maintain and
enforce patent and other intellectual property protection for any
drug candidates it is developing. These and other risks are
described under the caption "Risk Factors" in Karyopharm's
Quarterly Report on Form 10-Q for the quarter ended June 30, 2017,
which was filed with the Securities and Exchange Commission (SEC)
on August 8, 2017, and in other filings that Karyopharm may make
with the SEC in the future. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and, except as required by law, Karyopharm expressly disclaims any
obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise.
Opdivo® is a registered trademark of
Bristol-Meyers Squibb Company. Kyprolis® is a registered trademark
of Onyx Pharmaceuticals, Inc.Velcade® is a registered trademark of
Takeda Pharmaceutical Company Limited
Contacts:
KARYOPHARM THERAPEUTICS, INC.Investors:Kimberly
Minarovich(646) 368-8014kimberly@argotpartners.com
Gus Jenkins(646) 351-1067
gus@argotpartners.com
Media:Eliza Schleifstein(917)
763-8106eliza@argotpartners.com
ONO PHARMACEUTICAL CO., LTD.Corporate
Communicationspublic_relations@ono.co.jp
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