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NEWTON, Mass., May 15, 2019 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, congratulates its founder, President and Chief Scientific Officer, Sharon Shacham, PhD, MBA, for winning the esteemed New York Intellectual Property Law Association (NYIPLA) 2019 “Inventor of the Year” award. Dr. Shacham was recognized for her scientific research that led to the development of oral selinexor and related compounds. Selinexor is Karyopharm’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound for which a New Drug Application (NDA) is currently under Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of patients with heavily pretreated refractory myeloma.
Selinexor is currently in late-stage development for the treatment of a broad range of hematologic malignancies and solid tumors, including earlier line treatment of multiple myeloma, diffuse large B-cell lymphoma (DLBCL), liposarcoma and endometrial cancer. In addition to selinexor, other related novel SINE compounds, eltanexor and verdinexor, are being evaluated in other types of cancer as well as in neurodegenerative and inflammatory diseases.
“Dr. Shacham is a renowned expert in the biologic mechanisms of oncologic diseases and has been a pioneer in advancing research in a fundamental mechanism of oncogenesis: nuclear export dysregulation and tumor suppressor protein inactivation,” said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. “This award recognizes her important work designing and developing our lead investigational medicine, oral selinexor, which is currently under Priority Review by the FDA for its first target indication in patients with heavily pretreated multiple myeloma.”
Dr. Shacham stated, “I am honored to receive this award and to be recognized for the efforts to better understand nuclear transport abnormalities in cancer, which led to the creation of a novel, oral oncology medicine that has the potential to help patients across a wide range of hematologic malignancies and solid tumors. I sincerely hope this work will enable improved clinical outcomes for patients with relapsed refractory multiple myeloma as well as other high unmet need types of cancer.”
The award was presented on May 14, 2019 at the 2019 NYIPLA annual meeting at the Princeton Club in New York City. Past winners of this award have included the inventors of chimeric antigen receptor T-cell (CAR-T) therapy, Gleevec®, Valium®, LASIK laser vision correction and Priceline.com, among many others. For more information about the NYIPLA award, please visit https://www.nyipla.org/nyipla/InventoroftheYearAward.asp.
About Sharon Shacham, PhD, MBA
Dr. Shacham founded Karyopharm in 2008 and has served as our Chief Scientific Officer and President of Research and Development since December 2012. From 2010 to 2012, Dr. Shacham served as our Chief Scientific Officer and Head of Research and Development, and prior to that, as our President and Chief Executive Officer. Dr. Shacham has led our scientific progress since inception.
Prior to joining Karyopharm, Dr. Shacham served as Senior Vice President of Drug Development at Epix Pharmaceuticals, Inc., and Director, Algorithm and Software Development at Predix Pharmaceuticals Inc., which merged into Epix Pharmaceuticals in 2006, and where she led the company’s efforts in GPCR modeling, computational chemistry, lead optimization and development of clinical trials.
Dr. Shacham holds a Bachelor of Science in Chemistry, along with a Doctor of Philosophy in Biophysical Chemistry and a Master of Business of Administration from Tel Aviv University.
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.
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.
Karyopharm Therapeutics Inc.
Ian Karp, Vice President, Investor and Public Relations
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