Last $38.01 USD
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Volume 378.2K
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karyopharm therapeutics inc (KPTI) Details

Karyopharm Therapeutics Inc., a clinical-stage pharmaceutical company, focuses on the discovery and development of drugs directed against nuclear transport targets for the treatment of cancer and other major diseases. The company’s lead drug candidate, Selinexor, a novel selective inhibitors of nuclear export (SINE) compound that specifically blocks XPO1 cargo binding is in Phase I clinical trials in patients with heavily pretreated relapsed and/or refractory hematological and solid tumor malignancies. Its other drug candidates comprise KPT-350 and related SINE compounds; PAK4 inhibitors; and Verdinexor, an oral SINE compound that is in Phase 2b clinical trials in pet dogs with newly-diagnosed or first relapse after chemotherapy lymphomas. The company was founded in 2008 and is based in Natick, Massachusetts.

31 Employees
Last Reported Date: 03/24/14
Founded in 2008

karyopharm therapeutics inc (KPTI) Top Compensated Officers

Co-Founder, Chief Executive Officer, Director...
Total Annual Compensation: $380.5K
Co-Founder, Co-Chairman of Scientific Advisor...
Total Annual Compensation: $380.5K
Principal Financial Officer, Principal Accoun...
Total Annual Compensation: $160.5K
Compensation as of Fiscal Year 2013.

karyopharm therapeutics inc (KPTI) Key Developments

Karyopharm Initiates Registration-Directed, Randomized Study of Selinexor (KPT-330) in Older Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML)

Karyopharm Therapeutics Inc. announced the initiation of its Phase 2 study of Selinexor (KPT-330) in patients 60 years of age or older with relapsed or refractory acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy and/or transplantation. This Selinexor in Older Patients with Relapsed/Refractory AML (SOPRA) study is a randomized trial of Selinexor, the company's novel oral Selective Inhibitor of Nuclear Export (SINE) compound, versus physician's choice, and will be conducted at approximately 40 sites worldwide including sites in the United States, Canada, Europe and Israel. In SOPRA, 150 patients with AML which has relapsed after, or was refractory to, first line therapy will be randomized in a 2:1 fashion to Selinexor provided orally twice per week at a dose of 55mg/m(2) versus one of four physician choices. Physician choices include best supportive care (BSC) alone, or BSC plus either azacytidine (Vidaza), decitabine (Dacogen), or low dose cytosine arabinoside (LD-AraC). Overall survival is the primary endpoint. SOPRA was designed based on data from the ongoing Phase 1 study of Selinexor in patients with advanced hematologic malignancies, including AML. SOPRA is expected to take approximately two years to complete.

U.S. Food and Drug Administration Center Approves the New Animal Drug Application for Karyopharm Therapeutics Inc.'s Novel, Oral Selective Inhibitor of Nuclear Transport Compound Verdinexor for the Treatment of Canine Lymphoma

Karyopharm Therapeutics Inc. announced that the U.S. Food and Drug Administration Center for Veterinary Medicine has found the effectiveness and safety technical sections complete to support conditional approval under a New Animal Drug Application for Karyopharm's novel, oral Selective Inhibitor of Nuclear Transport compound Verdinexor (KPT-335) for the treatment of canine lymphoma. The use of Verdinexor to treat canine lymphoma has been designated a 'minor use' in accordance with the Minor Use Minor Species (MUMS) Act. This makes the product eligible for conditional approval similar to orphan drug/accelerated approvals used for submissions of human therapeutics. The effectiveness and safety technical sections of the NADA for Verdinexor were submitted to the FDA as part of a phased review approach to approval. The FDA has now agreed that the data presented in these sections can support the conditional approval of Verdinexor for canine lymphoma. Karyopharm anticipates working with a marketing partner to complete the final major technical section for the NADA, which covers the commercial-scale manufacturing (CMC) of Verdinexor. As part of conditional marketing approval, the sponsor is required to conduct a full, often randomized, study, to confirm the activity of the conditionally approved agent within five years. Following a Phase 1 dose escalation study, Verdinexor was tested in a Phase 2 study designed to meet requirements for conditional approval in companion dogs with B-cell or T-cell Non-Hodgkin's Lymphoma (NHL). The Phase 2 study was managed by Animal Clinical Investigation (ACI), conducted at ten ACI network clinics and academic institutions, and overseen by board certified veterinary medical oncologists at each site. Fifty-eight (58) pet dogs were enrolled in the study: 35 with newly diagnosed lymphoma and 23 with lymphoma at first relapse following standard injectable chemotherapy treatment. Of the 58 dogs, 42 had B-cell lymphoma, 14 had T-cell lymphoma and two had lymphoma of undetermined phenotype. Owners administered Verdinexor to their dogs two to three times per week by mouth after a meal at doses of 1.25-1.5 mg/kg. Response evaluation was based on objective measures per the Veterinary Cooperative Oncology Group (VCOG) standardized response criteria for peripheral lymphoma. Verdinexor was generally well tolerated with serious adverse events being uncommon. The most common side effect was reduced food intake, which was typically reversible with altered diet, the addition of low dose prednisone, and/or by alteration of Verdinexor dose or schedule. Single-agent Verdinexor induced an overall objective response rate of 34% (20/58 dogs) including 19 partial responses and one complete response (in a dog with T-cell lymphoma). There was little evidence of cumulative toxicity in treated dogs. Approximately 20% of dogs enrolled in this study continued on single agent Verdinexor therapy for more than three months and approximately 15% of the dogs continued therapy for more than four months. A validated quality of life questionnaire was completed by owners of dogs enrolled into this study at each treatment visit. Importantly, Verdinexor was shown to have no negative impact on the quality of life of dogs treated in this study, supporting the notion that this therapy is well tolerated over long-term administration.

Karyopharm Therapeutics, Inc. Ratifies the Selection of Ernst & Young LLP as its Independent Registered Public Accounting Firm for the Fiscal Year 2014

Karyopharm Therapeutics, Inc. announced that its stockholders ratified the selection of Ernst & Young LLP as its independent registered public accounting firm for the fiscal year 2014.


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