Karyopharm Therapeutics
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- -
- Employees
- 325
- Market Cap
- -
- Introduction
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.
Promising Pipeline for Soft Tissue Sarcoma Treatment Expands with 130+ Therapies in Development
• 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.
Robust Pipeline of 200+ Therapies Targets Colorectal Cancer Treatment Landscape
• DelveInsight's latest report reveals a robust pipeline with over 195 companies developing 200+ therapies for colorectal cancer, highlighting significant innovation in targeted treatments and immunotherapies.
• Key drug candidates include XL092 (Exelixis), Adagrasib (Mirati Therapeutics), Olaparib (Merck/AstraZeneca), and novel approaches like LYL845, an autologous tumor-infiltrating lymphocyte therapy from Lyell Immunopharma.
• The metastatic colorectal cancer segment shows particular promise with 150+ companies advancing 180+ pipeline therapies, including innovative treatments targeting specific mutations and immune pathways.
Pipeline Advances in Head and Neck Cancer Treatment: Over 100 Drugs in Development for 2025
• DelveInsight's latest report reveals a robust pipeline with over 80 companies developing 100+ drug candidates for head and neck cancer, highlighting significant research momentum in this therapeutic area.
• Key late-stage candidates include Debiopharm/Merck's xevinapant, GlaxoSmithKline's dostarlimab, and QBiotics' tigilanol tiglate, each employing novel mechanisms to potentially improve outcomes for patients with limited treatment options.
• Multiple clinical trials are underway testing innovative approaches including IAP inhibitors, immune checkpoint blockers, and oncolytic therapies, with several Phase III studies expected to deliver results that could reshape treatment paradigms.
Brain Hemorrhage Treatment Market Expected to Grow Significantly by 2032 as AI Solutions Gain FDA Approval
• The brain hemorrhage treatment market is projected to experience substantial growth through 2032, driven by an aging population and increasing prevalence of risk factors such as hypertension and traumatic brain injuries.
• Recent FDA approvals for AI-based diagnostic tools, including JLK-LVO and Heuron ICH, mark significant advancements in early detection and treatment of brain hemorrhages.
• Several pharmaceutical companies including Baxter, Pfizer, and Novartis are developing promising pipeline therapies such as tissue plasminogen activator, alteplase, and BAF312 to address the significant unmet needs in brain hemorrhage treatment.
Pipeline Progress: Over 25 New Therapies in Development for Metastatic Liver Cancer
• DelveInsight's latest report reveals a robust pipeline with over 20 companies developing 25+ therapies for metastatic liver cancer, offering new hope for patients with limited treatment options.
• Several promising clinical trials are underway in 2025, including studies evaluating novel combinations such as AK104 plus lenvatinib, tislelizumab with lenvatinib, and triplet therapy of nivolumab, relatlimab and bevacizumab.
• Key emerging therapies include exoASO-STAT6 targeting tumor-associated macrophages, STP705 dual TGF-ß1/COX-2 inhibitor, and ONCR-177, an oncolytic viral immunotherapy expressing five transgenes to fight tumors through multiple mechanisms.
Global Clinical Trials for Myelodysplastic Syndrome Show Significant Industry Investment in 2025
• A comprehensive review of global Myelodysplastic Syndrome clinical trials reveals extensive research activity across G7 and E7 countries, with major pharmaceutical companies leading development efforts.
• The analysis highlights significant participation from industry leaders including Bristol-Myers Squibb, Novartis, and Sanofi, demonstrating strong commercial interest in MDS therapeutics.
• The report indicates evolving clinical trial landscapes across multiple regions, with detailed tracking of trial phases, enrollment trends, and success rates over the past five years.
Xpovio Secures Public Health Insurance Coverage in Taiwan for Relapsed/Refractory Multiple Myeloma
• 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.
OST-HER2 Shows Promise in Preventing Recurrence of Lung Metastatic Osteosarcoma
• OST-HER2 demonstrated a statistically significant 12-month event-free survival (EFS) rate of 33.3% compared to 20% in historical controls for recurrent, fully resected osteosarcoma with lung metastases.
• Interim overall survival (OS) analysis showed a favorable trend for OST-HER2, with 1-year OS at 91% versus 80% in historical controls, and all patients achieving 12-month EFS remaining alive.
• The Phase 2b trial's positive results support OS Therapies' plans to engage with the FDA for accelerated approval of OST-HER2 in this challenging indication with no currently approved therapies.
• OST-HER2, a HER2-targeted immunotherapy, exhibited a strong safety profile in the study, further supporting its potential use in patients with recurrent lung metastatic osteosarcoma.
Karyopharm's Selinexor Shows Promise in Myelofibrosis, Phase 3 Data Expected in 2H 2025
• 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.
Selinexor Shows Promise in Treating KRAS-Mutated Non-Small Cell Lung Cancer
• A clinical trial reveals that selinexor, an FDA-approved drug, effectively shrinks tumors in non-small cell lung cancer (NSCLC) patients with KRAS mutations.
• The combination of selinexor and docetaxel controlled cancer in approximately 80% of cases, demonstrating effectiveness across various KRAS mutation types.
• Researchers observed that selinexor exhibited anti-tumor effects independently before docetaxel administration, suggesting its potential as a standalone treatment.
• This novel treatment offers hope for addressing the unmet clinical need for effective therapies targeting KRAS-mutated lung cancer, a challenging subset of the disease.
Karyopharm Announces FDA Discussions Regarding Selinexor's Endometrial Cancer Program
• 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.
XPOVIO® (Selinexor) Included in China's National Reimbursement Drug List for R/R DLBCL
• Antengene's XPOVIO® (selinexor) gains NRDL inclusion in China for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) post two or more systemic therapies.
• This marks XPOVIO®'s second indication in China to be included in the NRDL, enhancing patient access to this innovative treatment option.
• XPOVIO®, a selective XPO1 inhibitor, offers a novel mechanism of action and the convenience of oral administration for DLBCL patients.
• Antengene is further developing XPOVIO® in combination regimens for myelofibrosis and endometrial cancer, expanding its therapeutic potential.
Thrombocytopenia Treatment Market Shows Promising Growth with Novel Therapies and Clinical Trials
• The thrombocytopenia market is experiencing significant growth, driven by the introduction of novel therapies and ongoing clinical trials.
• Key players like Sanofi, Takeda, and Amgen are actively involved in developing and marketing treatments for various types of thrombocytopenia.
• Emerging therapies such as Rilzabrutinib and Nipocalimab show promise in addressing unmet needs in immune and alloimmune thrombocytopenia.
• Clinical trials are exploring new treatments for chemotherapy-induced thrombocytopenia and myelofibrosis-related thrombocytopenia.
Selinexor Data in Multiple Myeloma and Myelofibrosis to Be Presented at ASH 2024
• 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 Announces Positive Regulatory Update and Q3 2024 Financial Results
• Karyopharm's SENTRY trial endpoints are changing to absolute TSS following FDA discussions, increasing confidence in the trial's success.
• The company reported Q3 2024 U.S. XPOVIO net product revenue of $29.5 million, marking the third consecutive quarter of growth.
• Karyopharm narrows its full-year 2024 revenue guidance to $145-$155 million and expects current funds to last into Q1 2026.
• Selinexor's potential in myelofibrosis and endometrial cancer represents approximately $1 billion in potential annual U.S. peak revenues each.
Karyopharm's SENTRY Trial for Myelofibrosis Modifies Primary Endpoint Following FDA Feedback
• Karyopharm Therapeutics has changed the co-primary endpoint in its Phase 3 SENTRY trial to Absolute Total Symptom Score (Abs-TSS) after discussions with the FDA.
• The SENTRY trial evaluates selinexor combined with ruxolitinib in JAKi-naive myelofibrosis patients, with Spleen Volume Response Rate (SVR35) remaining a co-primary endpoint.
• Increased sample size to approximately 350 patients aims to enhance statistical power, with top-line data expected in the second half of 2025.
• Phase 1 data showed promising improvements in Abs-TSS and SVR35 with the selinexor and ruxolitinib combination, supporting the Phase 3 trial's rationale.
Karyopharm Announces Favorable Study Design Update for Phase 3 SENTRY Trial in JAKi-Naive Myelofibrosis
• 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.
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