Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage
pharmaceutical company, today announced that five abstracts
relating to selinexor, the Company’s first in class, oral SINE
compound, will be presented at the upcoming European Hematology
Association (EHA) 2019 Annual Meeting taking place June 13-16, 2019
in Amsterdam. The first abstract, which was selected for an
oral presentation, will highlight updated data from the Phase 1b/2
STOMP study arm evaluating selinexor and dexamethasone in
combination with Darzalex (daratumumab) in patients with relapsed
or refractory multiple myeloma. Two abstracts selected for
poster presentations will feature new and updated data,
respectively, from the STOMP arms evaluating selinexor and
dexamethasone in combination with Kyprolis (carfilzomib) or
Pomalyst (pomalidomide) in patients with relapsed or refractory
multiple myeloma.
Two additional abstracts will also be presented
regarding selinexor in acute myeloid leukemia (AML). One is
an oral presentation which describes data from a Phase 2 study
evaluating selinexor in combination with cytarabine and idarubicin
in patients with relapsed or refractory AML, and the other is a
poster that summarizes clinical data from the Phase 2 SOPRA study
evaluating single-agent selinexor in patients with relapsed or
refractory AML. As reported previously by Karyopharm in 2017,
the SOPRA study did not meet its pre-specified primary
endpoint.
“The Phase 1b/2 STOMP study continues to
generate encouraging efficacy and safety data from multiple ongoing
arms evaluating once weekly oral selinexor and dexamethasone in
combination with the standard approved myeloma therapies,” said
Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of
Karyopharm. “Of note, at EHA this year, we will be presenting
new data from the STOMP arm evaluating selinexor and dexamethasone
in combination with the proteasome inhibitor Kyprolis as well as
updated data from both the Darzalex and Pomalyst arms. There
remains a growing need for new therapies, especially ones with
novel mechanisms, for myeloma patients whose disease progresses
despite treatment with currently available combination
regimens. As such, the aim of the STOMP study is to establish
that selinexor holds the potential to be a safe and effective
backbone combination therapy option for patients with multiple
myeloma.”
Updated STOMP data from what appears in the
abstracts will be presented at this meeting.
Details for the EHA 2019 presentations
are as follows:
Oral Presentations
Title: Safety and Efficacy of
combination of Selinexor, Daratumumab, and Dexamethasone (SDd) in
Patients with Multiple Myeloma (MM) Previously Exposed to
Proteasome Inhibitors and Immunomodulatory DrugsLead
author: Cristina Gasparetto, Duke University Cancer
CenterAbstract #:
S1606Session: Myeloma and other monoclonal
gammopathies – ClinicalDate and Time: Sunday, June
16, 2019; 09:00 – 09:15 CESTLocation:
Auditorium
Title: A Phase 2 Study of Selinexor Plus
Cytarabine and Idarubicin in Patients with Relapsed/Refractory
Acute Myeloid Leukemia (AML)Lead author: Walter
Fiedler, Hubertus Wald University Cancer Center
HamburgAbstract #: S880Session:
Acute myeloid leukemia – Clinical Date and
Time: Saturday, June 15, 2019; 17:00 – 17:15
CESTLocation: Elicium 2
Poster Presentations
Title: Selinexor, Pomalidomide,
and Dexamethasone (SPd) in Patients with Relapsed or Refractory
Multiple Myeloma (RRMM)Lead author: Christina
Chen, Princess Margaret Cancer CenterAbstract #:
PF587Session: Myeloma and other monoclonal
gammopathies – ClinicalDate and Time: Friday, June
14, 2019; 17:30 – 19:00 CESTLocation: Poster
Area
Title: A Randomized,
Open-Label, Phase II Study of Selinexor Versus Physician’s Choice
(PC) In Older Patients with Relapsed or Refractory Acute Myeloid
Leukemia (AML)Lead author: Kendra Sweet, Moffitt
Cancer CenterAbstract #:
PF261Session: Acute myeloid leukemia – Clinical
Date and Time: Friday, June 14, 2019; 17:30 –
19:00 CESTLocation: Poster Area
Title: A Phase 1b/2 Study of
Selinexor, Carfilzomib, and Dexamethasone (SKd) in Relapsed/
Refractory Multiple Myeloma (RRMM)Lead
author: Cristina Gasparetto, Duke
University Cancer CenterAbstract #:
PS1414Session: Myeloma and other monoclonal
gammopathies – Clinical Date and Time:
Saturday, June 15, 2019; 17:30 – 19:00
CESTLocation: Poster Area
About Selinexor
Selinexor 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. In 2018, Karyopharm reported positive data from the
Phase 2b STORM study evaluating selinexor in combination with
low-dose dexamethasone in patients with triple class refractory
multiple myeloma who have been previously exposed to all five of
the most commonly prescribed anti-myeloma therapies currently
available. Selinexor has been granted Orphan Drug Designation in
multiple myeloma and Fast Track designation for the patient
population evaluated in the STORM study. Karyopharm's New Drug
Application (NDA) has been accepted for filing and granted Priority
Review by the FDA, and oral selinexor is currently under review by
the FDA as a possible new treatment for patients with triple class
refractory multiple myeloma. The Company has also submitted a
Marketing Authorization Application (MAA) to the European Medicines
Agency (EMA) with a request for conditional approval. Selinexor is
also being studied in patients with relapsed or refractory diffuse
large B-cell lymphoma (DLBCL). In 2018, Karyopharm reported
positive top-line results from the Phase 2b SADAL study evaluating
selinexor in patients with relapsed or refractory DLBCL after at
least two prior multi-agent therapies and who are ineligible for
transplantation, including high dose chemotherapy with stem cell
rescue. Selinexor has received Fast Track designation from the FDA
for the patient population evaluated in the SADAL study.
Selinexor is also being evaluated in several other 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), as a potential backbone therapy in
combination with approved therapies (STOMP), in liposarcoma (SEAL),
and an investigator-sponsored study 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
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.
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 our expectations relating to submissions to, and the
review and potential approval of selinexor by, regulatory
authorities, including the anticipated timing of such submissions
and actions, and the potential availability of accelerated approval
pathways, the therapeutic potential of and potential clinical
development plans for Karyopharm's drug candidates, especially
selinexor, and the plans for commercialization. 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
regulators will agree that selinexor qualifies for accelerated
approval in the U.S. or conditional approval in the E.U. as a
result of our clinical data, including the data from the STORM
study in patients with triple class refractory myeloma or the SADAL
study in patients with relapsed or refractory DLBCL, 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 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: 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; 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 March 31, 2019,
which was filed with the Securities and Exchange Commission (SEC)
on May 9, 2019, 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.
Contacts:
Investors: Karyopharm Therapeutics Inc. Ian
Karp, Vice President, Investor and Public Relations857-297-2241 |
ikarp@karyopharm.com
Media:Argot PartnersDavid Rosen212-600-1902 |
david.rosen@argotpartners.com
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