Karyopharm to Present Phase 1b/2 STOMP Clinical Data at the American Society of Hematology 2017 Annual Meeting

NEWTON, Mass., Nov. 01, 2017 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. KPTI, a clinical-stage pharmaceutical company, today announced that 14 abstracts have been selected for presentation, including three oral presentations, at the upcoming American Society of Hematology (ASH) 2017 annual meeting being held December 9-12, 2017 in Atlanta.  Four key abstracts being presented at the meeting will feature clinical data from Karyopharm's ongoing Phase 1b/2 STOMP study evaluating selinexor, the Company's lead, novel, oral SINE™ compound, in combination with backbone therapies for the treatment of patients with heavily pretreated multiple myeloma (MM).  The four STOMP presentations will include updated data from the arms evaluating selinexor in combination with Velcade® (bortezomib) and low-dose dexamethasone (SVd), selinexor in combination with Pomalyst® (pomalidomide) and low-dose dexamethasone (SPd), and selinexor in combination with Revlimid® (lenalidomide) and low-dose dexamethasone (SRd), and preliminary data from the arm evaluating selinexor in combination with Darzalex® (daratumumab) and low-dose dexamethasone (SDd).

"Despite several treatment advances for myeloma patients, there is a need for treatments with novel mechanisms, and many patients favor orally administered medicines," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm.  "Previously reported data from the ongoing Phase 1b/2 STOMP study showed promising response rates in patients with heavily pretreated myeloma when oral selinexor is combined with Velcade ("SVd") or Pomalyst ("SPd"). We are very pleased to provide updated data for selinexor in combination with these agents, new data for selinexor in combination with Revlimid ("SRd"), and early results from the new Darzalex ("SDd") combination arm at ASH this year.  We believe these data support the potential of selinexor as a backbone therapy with commonly used agents for multiple myeloma.  Moreover, we believe the new data continue to support our ongoing Phase 3 BOSTON study of SVd in myeloma."

Details for the ASH 2017 presentations are as follows:

Phase 1b/2 STOMP Study Data Presentations

Title: Selinexor in combination with weekly low dose bortezomib and dexamethasone (SVd) induces a high response rate with durable responses in patients with refractory multiple myeloma (MM)
Presenter: Nizar Bahlis, Southern Alberta Cancer Research Institute, Calgary, Alberta
Abstract Number/Publication ID: 3135
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 10, 2017; 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: Selinexor in Combination with Pomalidomide and Low Dose Dexamethasone in a Relapsed / Refractory Multiple Myeloma Patient Population with Prior Proteasome Inhibitor and Lenalidomide Exposure
Presenter: Christine Chen, Princess Margaret Cancer Center, Toronto, Ontario
Abstract Number/Publication ID: 3136
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 10, 2017; 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: A Phase Ib/II Trial of Selinexor Combined with Lenalidomide and Low Dose Dexamethasone in Patients with Relapsed / Refractory Multiple Myeloma
Presenter: Darrell White, Dalhousie University and QEII Health Sciences Center, Halifax; Nova Scotia
Abstract Number/Publication ID: 1861
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster I
Date and Time: Saturday, December 9, 2017; 5:30-7:30 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: A Phase 1b Study to Assess the Combination of Selinexor and Daratumumab in Patients with Relapsed/Refractory Multiple Myeloma Previously Exposed to Proteasome Inhibitors (PI) and Immunomodulatory Drugs (IMiDs)
Presenter: Cristina Gasparetto, Duke University Cancer Center, Durham, North Carolina
Abstract Number/Publication ID: 3100
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 10, 2017; 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Investigator-sponsored Study Oral Presentations

Title: Selinexor in Combination with Cladribine, Cytarabine and G-CSF for Relapsed or Refractory AML
Presenter: Geoffrey Uy, Washington University School of Medicine in St. Louis
Abstract Number/Publication ID: 816
Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Novel Targeted and Immune-based Approaches in the Treatment of AML; Monday, December 11, 2017 from 4:30-6:00 PM ET
Date and Time: Monday, December 11, 2017 at 5:45 PM ET
Location: Georgia World Congress Center, Building B, Level 5, Murphy BR 1-2

Investigator-sponsored Study Poster Presentations

Title: Selinexor maintenance is feasible and tolerable after allogeneic stem cell transplant (allo-SCT) for patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
Presenter: Hongtao Liu, University of Chicago Medical Center
Abstract Number/Publication ID: 3312
Session: 732. Clinical Allogeneic Transplantation: Results: Poster II
Date and Time: Sunday, December 10, 2017 from 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: A Phase I/II study of Selinexor (SEL) with Sorafenib in Patients (pts) with Relapsed and/or Refractory (R/R) FLT3 mutated Acute Myeloid Leukemia (AML)
Presenter: Naval Daver, University of Texas MD Anderson Cancer Center
Abstract Number/Publication ID: 1344
Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster I
Date and Time: Saturday, December 9, 2017 from 5:30-7:30 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: Phase I/II Study of Liposomal Doxorubicin (DOX) in Combination with Selinexor (SEL) and Dexamethasone (Dex) for Relapsed and Refractory Multiple Myeloma (RRMM)
Presenter: Rachid Baz, H. Lee Moffitt Cancer Center and Research Institute
Abstract Number/Publication ID: 3095
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 10, 2017 from 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Preclinical Oral Presentations

Title: Non-cytotoxic Low Doses of Selinexor Promote the Differentiation of AML Cells Harboring Mutant-NPM1 into Monocytes
Presenter: Saunthararajah Yogen, Cleveland Clinic
Abstract Number/Publication ID: 105742
Session: 603. Oncogenes and Tumor Suppressors: Nuclear Export and Metabolic Regulation; Monday, December 11, 2017, 6:15-7:45 PM ET
Date and Time: Monday, December 11, 2017 at 6:30 PM ET
Location: Georgia World Congress Center, Building C, Level 1, C101 Auditorium

Title: PAK4 Inhibition Impacts Growth and Survival, and Increases Sensitivity to DNA-Damaging Agents in Waldenstrom Macroglobulinemia
Presenter: Li Na, Dana Farber Cancer Institute
Abstract Number/Publication ID: 102879
Session: 622. Lymphoma Biology—Non-Genetic Studies: Novel Mechanisms Implicated in Lymphoma Biology; Monday, December 11, 2017, 10:30AM – 12:00 PM ET
Date and Time: Monday, December 11, 2017 at 11:45 AM ET
Location: Georgia World Congress Center, Building C, Level 1, C101 Auditorium

Preclinical Poster Presentations

Title: XPO1 Inhibitor Selinexor Overcomes Ibrutinib Resistance in Mantle Cell Lymphoma (MCL) via Nuclear Retention of IκB
Presenter: Mei Ming, University of Chicago
Abstract Number/Publication ID: 104320
Session: 605. Molecular Pharmacology, Drug Resistance-Lymphoid and Other Diseases
Date and Time: Monday, December 11, 2017; 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: XPO1 Inhibition Synergizes with BCR Inhibition, Blocks Tumor Growth and Prolongs Survival in a Bioluminescent Animal Model of Primary Central Nervous System Lymphoma
Presenter: Marta Crespo, Hall d'Hebron, Barcelona
Abstract Number/Publication ID: 107008
Session: 625. Lymphoma: Pre-Clinical-Chemotherapy and Biologic Agents
Date and Time: Sunday, December 10, 2017; 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: Eltanexor (KPT-8602), a Second-Generation Selective Inhibitor of Nuclear Export (SINE) Compound, in Patients with Refractory Multiple Myeloma
Presenter: Robert Frank Cornell, Vanderbilt University Medical Center
Abstract Number/Publication ID: 107422
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 10, 2017; 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

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 Karyopharm Therapeutics

Karyopharm Therapeutics Inc. 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 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 or eltanexor (KPT-8602), 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: 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 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.

Velcade® is a registered trademark of Takeda Pharmaceutical Company Limited.
Revlimid® and Pomalyst® are registered trademarks of Celgene Corporation.
Darzalex® is a registered trademark of Janssen Biotech, Inc.

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