Karyopharm Therapeutics, Inc. is a commercial-stage pharmaceutical company, which engages in the discovery, development, and commercialization of drugs directed against nuclear export for the treatment of cancer and other diseases. Its Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm’s compound, XPOVIO (selinexor), is approved in the U.S. in multiple hematologic malignancy indications, including in combination with Velcade (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of adult patients with pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. 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. The company was founded by Joseph Araujo, Ronald A. DePinho, Pamela A, Silver, Giulio Draetta, Michael G. Kauffman, and Sharon Shacham on December 22, 2008 and is headquartered in Newton, MA.
相关临床试验
48
35 进行中
药物批准
3
批准总数
监管机构
2
监管机构数
成立时间
N/A
进行中（未招募）
35
72.9%
已完成
1
2.1%
招募中
10
20.8%
终止
1
2.1%
撤回
1
2.1%
- Menarini Group will present seven oncology presentations at ASCO 2026, spanning both solid tumors and hematologic malignancies with focus on difficult-to-treat cancers. - New data from the ELEVATE study will showcase elacestrant plus capivasertib combination therapy in ER+/HER2- metastatic breast cancer patients with PI3K/AKT/PTEN pathway alterations. - Updates from multiple elacestrant clinical trials will be shared, including the phase 3 ELEGANT study evaluating adjuvant treatment in high-risk early breast cancer. - Karyopharm Therapeutics will present late-breaking phase 3 SENTRY trial data for selinexor in JAK inhibitor-naïve myelofibrosis patients.
- Karyopharm expects top-line data from its Phase 3 SENTRY trial evaluating selinexor plus ruxolitinib in myelofibrosis patients in March 2026, potentially unlocking the first combination therapy in this multi-billion dollar market. - The company also anticipates mid-2026 results from its Phase 3 XPORT-EC-042 trial in endometrial cancer, representing another significant opportunity for patient outcomes in a targeted population. - Preliminary 2025 revenue reached approximately $145 million total and $115 million in U.S. XPOVIO net product sales, with cash runway extending beyond the expected SENTRY trial readout.
- A new comprehensive report analyzes over 200 pipeline drugs from 180+ companies targeting metastatic hormone refractory prostate cancer, highlighting the extensive research efforts in this challenging therapeutic area. - Key late-stage candidates include PNT2002 by Lantheus targeting PSMA in Phase III trials, and Opevesostat by Merck, an oral CYP11A1 inhibitor also in Phase III development. - The pipeline spans multiple development stages from discovery to Phase III, with promising mid-stage candidates like XL092 by Exelixis exploring receptor tyrosine kinase inhibition in Phase II trials. - Current treatment approaches involve next-generation androgen receptor inhibitors and chemotherapy agents, but significant unmet needs remain for patients experiencing disease progression despite anti-androgen treatments.
- Karyopharm Therapeutics has laid off 20% of its workforce as part of ongoing expense management while seeking strategic alternatives including potential mergers or sales. - The oncology biotech company has accumulated a $1.6 billion deficit and is struggling with declining revenue from its approved drug Xpovio, which generated $30 million in Q2 2024. - The company's pipeline centers on eltanexor, an oral XPO1 inhibitor for myelodysplastic neoplasms that showed a 31% response rate in phase 1/2 trials. - Despite ongoing discussions with investors for financing transactions, no deals have materialized, prompting continued evaluation of restructuring options.
- Global soft tissue sarcoma pipeline constitutes 125+ companies developing 130+ treatment therapies, with significant progress in clinical trials across various stages of development. - FDA grants Orphan Drug Designation to Actuate Therapeutics' elraglusib for soft tissue sarcoma treatment, highlighting its potential to address unmet needs in this rare cancer. - Novel approaches include tumor-targeting antibody-cytokine fusion proteins, intratumoral administration techniques, and GSK-3β inhibition, offering hope for improved outcomes in this challenging disease.
• Antengene's Xpovio (selinexor), the world's first oral XPO1 inhibitor, will be included in Taiwan's National Health Insurance reimbursement scheme starting March 1, 2025, benefiting patients with relapsed/refractory multiple myeloma. • Multiple myeloma represents the second most common hematologic malignancy in Taiwan, with 700-800 new diagnoses and approximately 400 deaths annually, creating significant treatment challenges for patients. • Taiwan becomes the fifth APAC market to provide public insurance coverage for Xpovio, following mainland China, South Korea, Australia, and Singapore, with Antengene pursuing additional indications including myelofibrosis and endometrial cancer.
- Karyopharm Therapeutics anticipates top-line results from its Phase 3 SENTRY trial of selinexor plus ruxolitinib for JAKi-naïve myelofibrosis in the second half of 2025. - The SENTRY trial updated its co-primary endpoint to absolute mean change in total symptom score (Abs-TSS) and increased the sample size to 350 patients. - Preliminary 2024 results show total revenue of approximately $145 million, with XPOVIO net product revenue reaching $113 million for Karyopharm.
- Karyopharm Therapeutics is engaging with the FDA to discuss the evolving treatment landscape in endometrial cancer and its impact on the Phase 3 XPORT-EC-042 trial. - The XPORT-EC-042 trial is evaluating selinexor as maintenance therapy for TP53 wild-type advanced or recurrent endometrial cancer following systemic treatment. - Karyopharm has paused discussions on its endometrial cancer program at the Piper Sandler conference, awaiting further clarity from the FDA interaction. - An update on the endometrial cancer program will be provided by Karyopharm following the discussions with the FDA.
- Karyopharm will present data on selinexor in relapsed or refractory multiple myeloma (RRMM) at the ASH Annual Meeting. - Selinexor's effect on hematopoietic stem cells in ruxolitinib-refractory myelofibrosis will also be presented. - Antengene will present Phase 3 data on weekly selinexor, bortezomib, and dexamethasone (SVd) versus bortezomib and dexamethasone (Vd) in Chinese RRMM patients.
- Karyopharm Therapeutics announced a favorable study design update for its pivotal Phase 3 SENTRY trial evaluating selinexor in JAKi-naive myelofibrosis patients. - The SENTRY trial is designed to assess the efficacy and safety of selinexor in myelofibrosis patients who have not yet been treated with JAK inhibitors. - Key opinion leaders, including Dr. Raajit Rampal and Dr. John Mascarenhas, are involved in the trial and will participate in an investor event to discuss the update. - Karyopharm's lead compound, selinexor (XPOVIO/NEXPOVIO), is an oral exportin 1 (XPO1) inhibitor already approved for several oncology indications.
