NEWTON, Mass., Dec. 1, 2020 /PRNewswire/ -- Karyopharm
Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical
company pioneering novel cancer therapies, today announced the
appointments of Chen Schor, MBA, to
its Board of Directors and Stephen
Mitchener, PharmD, as Chief Business Officer. Mr. Schor
currently serves as President and Chief Executive Officer and a
member of the board of directors of Adicet Bio, Inc., a
biotechnology company discovering and developing first-in-class
therapies for cancer and other diseases. Dr. Mitchener joins
Karyopharm from Axcella Healthcare, a clinical-stage biotechnology
company pioneering a new approach to treat complex diseases and
improve health, where he served as Chief Business Officer and Head,
Strategic Finance, and spearheaded all commercial, financing,
partnering, and corporate development initiatives.
"We are thrilled to welcome Chen and Stephen to the Karyopharm
team as we continue to execute on our goal of advancing novel
treatment options for patients with cancer and other serious
diseases," said Michael G. Kauffman,
MD, PhD, Chief Executive Officer of Karyopharm. "Chen is a
recognized and skilled leader in the biotechnology industry who has
served as President and CEO of multiple, innovative
biopharmaceutical companies. Regarding Stephen, his extensive
experience leading partnering, marketing, as well as key commercial
and strategic initiatives, will be critical to Karyopharm as we
look to expand our commercial reach by leveraging our internal
capabilities as well as through potential strategic partnerships.
We look forward to their contributions as we enter this next
chapter of growth for XPOVIO®(selinexor) and our emerging clinical
pipeline."
"I believe Karyopharm is just beginning to achieve its ambitious
goal of becoming a leader in the oncology space whose future growth
will be driven by the broad therapeutic potential of oral XPOVIO in
both hematological malignancies and solid tumors," said Mr. Schor.
"I hope that my deep experience in leading several commercial and
development-stage biotechnology companies will be beneficial in
helping to guide Karyopharm to maximize its impact on improving
future patient outcomes."
Dr. Mitchener added, "I am delighted to join the Karyopharm team
to help expand the global potential of XPOVIO and Karyopharm's
growing pipeline. I am honored to have the opportunity to play a
key role in pioneering innovation for patients in need of new
cancer treatment options."
Mr. Schor has led biotechnology companies across all stages,
from formation and early stage discovery to leading a publicly
traded multi-product company with significant external
partnerships. He has spearheaded several strategic transactions
valued at over $8 billion with
companies such as GSK, Amgen, Pfizer, Merck KGaA and Cephalon.
Prior to co-founding resTORbio and closing its merger with Adicet,
Mr. Schor led the turnaround of Synta Pharmaceuticals and its
reverse merger with Madrigal Pharmaceuticals. Previously, he served
as President and Chief Executive Officer at Novalere, Chief
Business Officer at Eleven Biotherapeutics, Vice President, Global
Branded Business Development and Pipeline Management, at Teva
Pharmaceuticals and Chief Business Officer at Predix
Pharmaceuticals. Before that, Mr. Schor was a Partner at Yozma
Venture Capital where he led the foundation and growth of multiple
therapeutic companies from inception to commercial success. Mr.
Schor received an MBA and a BA in Biology from Tel Aviv University, a BA in Economics and
Accounting from Haifa University and is
a Certified Public Accountant.
Before joining Axcella Healthcare in 2018, Dr. Mitchener spent
15 years at Novartis in roles of increasing responsibility, in both
U.S. and international roles within its Oncology Business. As Head
of Strategy, Partnering and Operations, Dr. Mitchener was
responsible for leading U.S. oncology strategy, enterprise
operations, non-core brands and partnering activities. During his
tenure at Novartis, he also held various commercial, medical and
business development roles, including Business Franchise Head,
Oncology, Global Pharma Strategy Director, and Global New Product
Director. Dr. Mitchener was involved in securing partnerships in
oncology with multiple Big Pharma, technology, academic and
healthcare partners. He received a PharmD from the University of North Carolina at Chapel Hill.
Inducement Grants Under Nasdaq Listing Rule
5635(c)(4)
In connection with the hiring of Dr. Mitchener, the Compensation
Committee of Karyopharm's Board of Directors granted a stock option
to purchase 100,000 shares of Karyopharm's common stock to Dr.
Mitchener, with a grant date of November 30,
2020. The stock option was granted as an inducement material
to Dr. Mitchener entering into employment with Karyopharm in
accordance with Nasdaq Listing Rule 5635(c)(4).
The Compensation Committee also granted stock options to
purchase an aggregate of 59,000 shares of Karyopharm's common stock
to 11 additional newly-hired employees, with a grant date of
November 30, 2020. The stock options
were granted as inducements material to the new employees entering
into employment with Karyopharm in accordance with Nasdaq Listing
Rule 5635(c)(4).
Each of the stock options has an exercise price of $16.99
per share, the closing price of Karyopharm's common stock on
November 30, 2020. Each stock option
vests over four years, with 25% of the total number of shares
underlying the stock option vesting on the one-year anniversary of
the applicable employee's employment commencement date and 1/48th
of the total number of shares vesting monthly thereafter, subject
to the employee's continued service as an employee of, or other
service provider to, Karyopharm through the applicable vesting
dates. In addition, each stock option will be immediately
exercisable in full if, on or prior to the first anniversary of the
consummation of a "change in control event," the employee's
employment is terminated for "good reason" by the employee or
terminated without "cause" by Karyopharm (as such terms are defined
in the applicable stock option agreement).
About XPOVIO® (selinexor)
XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear
Export (SINE) compound. XPOVIO functions by selectively binding to
and inhibiting the nuclear export protein exportin 1 (XPO1, also
called CRM1). XPOVIO blocks the nuclear export of tumor suppressor,
growth regulatory and anti-inflammatory proteins, leading to
accumulation of these proteins in the nucleus and enhancing their
anti-cancer activity in the cell. The forced nuclear retention of
these proteins can counteract a multitude of the oncogenic pathways
that, unchecked, allow cancer cells with severe DNA damage to
continue to grow and divide in an unrestrained fashion. Karyopharm
received accelerated U.S. Food and Drug Administration (FDA)
approval of XPOVIO in July 2019 in
combination with dexamethasone for the treatment of adult patients
with relapsed or refractory multiple myeloma (RRMM) who have
received at least four prior therapies and whose disease is
refractory to at least two proteasome inhibitors, at least two
immunomodulatory agents, and an anti-CD38 monoclonal antibody.
Karyopharm has also submitted a Marketing Authorization Application
(MAA) to the European Medicines Agency (EMA) with a request for
conditional approval of selinexor in this same RRMM indication.
Karyopharm's supplemental New Drug Application (sNDA) requesting an
expansion of its current indication to include the treatment for
patients with multiple myeloma after at least one prior line of
therapy has been accepted for filing by the FDA. In June 2020, Karyopharm received accelerated FDA
approval of XPOVIO for its second indication in adult patients with
relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not
otherwise specified, including DLBCL arising from follicular
lymphoma, after at least 2 lines of systemic therapy. Selinexor is
also being evaluated in several other mid-and later-phase clinical
trials across multiple cancer indications, including as a potential
backbone therapy in combination with approved myeloma therapies
(STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO),
among others. Additional Phase 1, Phase 2 and Phase 3 studies are
ongoing or currently planned, including multiple studies in
combination with 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 Karyopharm Therapeutics
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) is a
commercial-stage pharmaceutical company pioneering novel cancer
therapies and dedicated to the discovery, development, and
commercialization of novel first-in-class drugs directed against
nuclear export and related targets for the treatment of cancer and
other major diseases. Karyopharm's Selective Inhibitor of Nuclear
Export (SINE) compounds function by binding with and inhibiting the
nuclear export protein XPO1 (or CRM1). Karyopharm's lead compound,
XPOVIO® (selinexor), received accelerated approval from the U.S.
Food and Drug Administration (FDA) in July
2019 in combination with dexamethasone as a treatment for
patients with heavily pretreated multiple myeloma. In June 2020, XPOVIO was approved by the FDA as a
treatment for patients with relapsed or refractory diffuse large
B-cell lymphoma. A Marketing Authorization Application for
selinexor for patients with heavily pretreated multiple myeloma is
also currently under review by the European Medicines Agency. 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 has several
investigational programs in clinical or preclinical development.
For more information, please visit www.karyopharm.com.
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
Karyopharm's expectations and plans relating to the global
development and commercialization of XPOVIO. Such statements are
subject to numerous important factors, risks and uncertainties,
many of which are beyond Karyopharm's control, that may cause
actual events or results to differ materially from Karyopharm's
current expectations. For example, there can be no guarantee that
Karyopharm will successfully commercialize XPOVIO; that regulators
will agree that selinexor qualifies for conditional approval in the
E.U. as a result of data from the STORM study or confirmatory
approval in the U.S. or EU based on the BOSTON study in patients with relapsed or
refractory multiple myeloma; or that any of Karyopharm's
drug candidates, including selinexor, will successfully
complete necessary 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 the
development or commercialization of 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
risk that the COVID-19 pandemic could disrupt Karyopharm's
business more severely than it currently anticipates, including by
negatively impacting sales of XPOVIO, interrupting or delaying
research and development efforts, impacting the ability to procure
sufficient supply for the development and commercialization of
selinexor or other product candidates, delaying ongoing or planned
clinical trials, impeding the execution of business plans, planned
regulatory milestones and timelines, or inconveniencing patients;
the adoption of XPOVIO in the commercial marketplace, the timing
and costs involved in commercializing XPOVIO or any of Karyopharm's
drug candidates that receive regulatory approval; the ability to
retain regulatory approval of XPOVIO or any of Karyopharm's drug
candidates that receive regulatory approval; 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 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; the ability of Karyopharm or its third
party collaborators or successors in interest to fully perform
their respective obligations under the applicable agreement and the
potential future financial implications of such agreement;
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
September 30, 2020, which was filed with the Securities and
Exchange Commission (SEC) on November 2, 2020, 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.
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SOURCE Karyopharm Therapeutics Inc.