KPTI Karyopharm Therapeutics Inc.

8.33
-0.04  -0%
Previous Close 8.37
Open 8.32
52 Week Low 7.78
52 Week High 18
Market Cap $625,521,083
Shares 75,092,567
Float 71,338,442
Enterprise Value $585,609,785
Volume 720,264
Av. Daily Volume 1,203,368
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Upcoming Catalysts

Drug Stage Catalyst Date
XPOVIO (selinexor) - SIENDO
Endometrial cancer
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
XPOVIO (selinexor) and JAKAFI (ruxolitinib) - (XPORT-MF-034)
Myelofibrosis
Phase 1/2
Phase 1/2
Phase 1/2 initiation of dosing announced July 28, 2021.
XPOVIO (selinexor) and KEYTRUDA (pembrolizumab) - (XPORT-MEL-033)
Melanoma
Phase 2
Phase 2
Phase 2 initiation of dosing announced July 28, 2021.
KPT-9274
Non-Hodgkin Lymphoma
Phase 1/2
Phase 1/2
Phase 1/2 ongoing.
XPOVIO (selinexor)
Relapsed/Refractory Acute Myeloid Leukemia (AML)
Phase 2
Phase 2
Data Safety Monitoring Board (DSMB) noted March 2, 2017 that trial will not meet primary endpoint.
XPOVIO (selinexor)
COVID-19 Coronavirus
Phase 2
Phase 2
Phase 2 data noted unlikely to demonstrate efficacy benefit across entire patient population with benefit in a clearly defined subpopulation of patients.
XPOVIO (selinexor)
Diffuse Large B-Cell Lymphoma (DLBCL)
Approved
Approved
FDA Approval announced June 22, 2020.
XPOVIO (selinexor)
Glioblastoma
Phase 1/2
Phase 1/2
Phase 1/2 commencement of dosing announced June 9, 2020.
XPOVIO (selinexor)
Multiple myeloma
Approved
Approved
FDA approval announced December 18, 2020.
XPOVIO (selinexor)
Dedifferentiated liposarcoma
Phase 3
Phase 3
Phase 3 trial met primary endpoint - November 2, 2020.
XPOVIO (selinexor)
Quadruple Refractory Multiple Myeloma
Approved
Approved
FDA Approval announced July 3, 2019.

Latest News

  1. NEWTON, Mass., July 29, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that it will report second quarter 2021 financial results on Thursday, August 5, 2021. Karyopharm's management team will host a conference call and audio webcast at 8:30 a.m. ET on Thursday, August 5, 2021, to discuss the financial results and other company updates.

    To access the conference call, please dial (888) 437-3179 (local) or (862) 298-0702 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call will be available under "Events & Presentations" in the Investor…

    NEWTON, Mass., July 29, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that it will report second quarter 2021 financial results on Thursday, August 5, 2021. Karyopharm's management team will host a conference call and audio webcast at 8:30 a.m. ET on Thursday, August 5, 2021, to discuss the financial results and other company updates.

    To access the conference call, please dial (888) 437-3179 (local) or (862) 298-0702 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call will be available under "Events & Presentations" in the Investor section of the Company's website, http://investors.karyopharm.com/events-presentations. An archived webcast will be available on the Company's website approximately two hours after the event.

    About Karyopharm Therapeutics

    Karyopharm Therapeutics Inc. (NASDAQ:KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer and other diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead 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 heavily pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. NEXPOVIO® (selinexor) has also been granted conditional marketing authorization in combination with dexamethasone for adult patients with heavily pretreated multiple myeloma by the European Commission. 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. For more information, please visit www.karyopharm.com.

    Cision View original content:https://www.prnewswire.com/news-releases/karyopharm-to-report-second-quarter-2021-financial-results-on-august-5-2021-301343871.html

    SOURCE Karyopharm Therapeutics Inc.

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  2. NEWTON, Mass., July 28, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced dosing of the first patients in two new company-sponsored Phase 2 and 1/2 clinical studies evaluating XPOVIO® (selinexor), the Company's first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound in combination with approved therapies in patients with advanced melanoma and in patients with treatment naïve myelofibrosis. These company-sponsored studies follow encouraging results from preclinical research and earlier stage, investigator-sponsored clinical studies conducted by Karyopharm's scientific collaborators.

    "Despite recent advances in treatment…

    NEWTON, Mass., July 28, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced dosing of the first patients in two new company-sponsored Phase 2 and 1/2 clinical studies evaluating XPOVIO® (selinexor), the Company's first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound in combination with approved therapies in patients with advanced melanoma and in patients with treatment naïve myelofibrosis. These company-sponsored studies follow encouraging results from preclinical research and earlier stage, investigator-sponsored clinical studies conducted by Karyopharm's scientific collaborators.

    "Despite recent advances in treatment options for both metastatic melanoma and myelofibrosis, far too many patients either do not respond or have short-lived responses to currently available treatment options, making the development of novel drug treatment approaches incredibly important for these diseases," said Sharon Shacham, PhD, MBA, Chief Scientific Officer of Karyopharm. "Substantial need remains for continued research into new druggable targets and identifying multiple targets and pathways that have the potential to be inhibited synergistically using combination approaches. We believe XPOVIO's oral administration, along with its novel mechanism of action, make it a promising treatment candidate for new, single and synergistic combination regimens across both hematologic and solid tumors."

    Summary of Newly Initiated Clinical Studies:

    A Phase 2 Study Evaluating XPOVIO in Combination with Keytruda® (pembrolizumab) in Recurrent Advanced Melanoma

    This Phase 2, multicenter, open-label study (XPORT-MEL-033; NCT04768881) will evaluate the safety and efficacy of XPOVIO in combination with Keytruda® and is expected to enroll approximately 40 patients with locally advanced or metastatic melanoma that is resistant to initial checkpoint inhibitor therapy. Patients will receive once-weekly oral XPOVIO (80mg) and Keytruda® (400mg intravenously once every six weeks) until disease progression, toxicity or withdrawal from the study, whichever occurs first. The primary endpoint of the study is overall response rate (ORR). Secondary endpoints include safety, progression-free survival, overall survival (OS), and complete response rate, among several others.

    Preclinical studies have shown that XPOVIO selectively kills malignant melanoma cells and synergistically increases the antitumor activity of check point inhibitors1,2,3. Two early clinical studies, one investigating XPOVIO as a single agent4 and one investigating XPOVIO plus Keytruda5, in heavily pretreated advanced melanoma, have shown that this activity is borne out in clinical studies.

    A Phase 1/2 Study Evaluating XPOVIO in Combination with Jakafi® (ruxolitinib) in Treatment Naïve Myelofibrosis

    This global Phase 1/2, multicenter, open-label study (XPORT-MF-034; NCT04562389) will evaluate the safety and efficacy of XPOVIO in combination with Jakafi® and is expected to enroll approximately 237 patients with treatment naïve myelofibrosis. The study will be conducted in two phases: Phase 1a/1b and Phase 2. The Phase 1a dose escalation portion of the study will determine the maximum tolerated dose and the recommended Phase 2 dose (RP2D) and will evaluate safety and preliminary efficacy. The Phase 1b dose expansion portion of the study will be conducted at the determined RP2D and will further assess the safety and preliminary efficacy at this dose level. In the Phase 2 portion of the study, patients will be randomized 1:1 to receive either once weekly XPOVIO plus Jakafi® (15mg or 20mg twice daily) or Jakafi® (15mg or 20mg twice daily) monotherapy. The primary endpoint for the Phase 2 portion of the study is the percentage of patients who achieve spleen volume reduction of at least 35% from baseline. Secondary endpoints for the Phase 2 portion of the study include safety, percentage of patients who achieve total symptom score reduction of ≥50%, OS, anemia response and ORR, among several others.

    This new Phase 1/2 study is supported by multiple preclinical data sets which showed that (i) nuclear cytoplasmic transport is essential for survival of JAK2V617F-mutant HEL cells in vitro, a major vulnerability and a potential therapeutic target in MF6, (ii) that XPOVIO significantly reduced white blood cells (WBCs), granulocytes and spleen GFP+ cells in in vivo models of JAK2V617F-driven myeloproliferative neoplasms, and (iii) the combination of XPOVIO and ruxolitinib in vivo showed significant reduction in WBCs, granulocytes, spleen GFP+ cells, as well as in spleen weight when compared to either agent alone7.  Collectively, these data support the clinical investigation of XPOVIO combined with ruxolitinib in patients with myelofibrosis. 

    About XPOVIO® (selinexor)

    XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. NEXPOVIO® (selinexor) has also been granted conditional marketing authorization for adult patients with heavily pretreated multiple myeloma by the European Commission. Karyopharm's supplemental New Drug Application (sNDA) requesting an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA on December 18, 2020. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP) and 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.

    For more information about Karyopharm's products or clinical trials, please contact the Medical Information department at:

    Tel: +1 (888) 209-9326

    Email: 

    XPOVIO® (selinexor) is a prescription medicine approved:

    • In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).
    • In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti‐CD38 monoclonal antibody (Xd).
    • For the treatment of adult patients with relapsed or refractory diffuse large B‐cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

    SELECT IMPORTANT SAFETY INFORMATION

    Warnings and Precautions

    • Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
    • Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony‐stimulating factors.
    • Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
    • Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
    • Serious Infection: Monitor for infection and treat promptly.
    • Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
    • Embryo‐Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
    • Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.

    Adverse Reactions

    • The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3‐4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.
    • The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
    • The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3‐4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection(21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.

    Use In Specific Populations

    Lactation: Advise not to breastfeed.

    For additional product information, including full prescribing information, please visit www.XPOVIO.com.

    To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1‐888‐209‐9326 or FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch. 

    About Karyopharm Therapeutics

    Karyopharm Therapeutics Inc. (NASDAQ:KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer and other diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead 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 heavily pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. NEXPOVIO® (selinexor) has also been granted conditional marketing authorization in combination with dexamethasone for adult patients with heavily pretreated multiple myeloma by the European Commission. 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. 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 Karyopharm's expectations and plans relating to XPOVIO for the treatment of hematologic malignancies or certain solid tumors; the expected design of the Company's clinical trials; and the therapeutic potential of and potential clinical development plans for Karyopharm's drug candidates, especially selinexor. 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 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 the development or commercialization of 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: the risk that the COVID-19 pandemic could disrupt Karyopharm's business more severely than it currently anticipates, including by negatively impacting sales of XPOVIO, interrupting or delaying research and development efforts, impacting the ability to procure sufficient supply for the development and commercialization of selinexor or other product candidates, delaying ongoing or planned clinical trials, impeding the execution of business plans, planned regulatory milestones and timelines, or inconveniencing patients; the adoption of XPOVIO in the commercial marketplace, the timing and costs involved in commercializing XPOVIO or any of Karyopharm's drug candidates that receive regulatory approval; the ability to retain regulatory approval of XPOVIO or any of Karyopharm's drug candidates that receive regulatory approval; 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; the ability of Karyopharm or its third party collaborators or successors in interest to fully perform their respective obligations under the applicable agreement and the potential future financial implications of such agreement; Karyopharm's ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development or regulatory approval of drug candidates by Karyopharm's competitors for products or product candidates in which Karyopharm is currently commercializing or developing; and Karyopharm's ability to obtain, maintain and enforce patent and other intellectual property protection for any of its products or product candidates. 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, 2021, which was filed with the Securities and Exchange Commission (SEC) on May 4, 2021, 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.

    XPOVIO®(selinexor) is a registered trademark of Karyopharm Therapeutics Inc. Any other trademarks referred to in this press release are the property of their respective owners.

    References

    1 Fragomeni RA, et al. Cancer Ther. 2013 Jul 1;12(7):1171-9.

    2 Breit MN, et al. Mol Cancer Ther. 2017 Mar 1;16(3):417-27.

    4 Abdul Razak AR, et al. J Clin Oncol. 2016 Dec 1;34(34):4142.

    5 Data on file at Karyopharm.

    6 Deininger, MW, et al. Clin Cancer Res April 1 2019 (25) (7) 2323-2335.

    7 Tan, D, et al. Clin Cancer Res . 2019 Apr 1;25(7):2323-2335.

    Cision View original content:https://www.prnewswire.com/news-releases/karyopharm-announces-dosing-of-first-patients-in-two-new-company-sponsored-clinical-studies-in-melanoma-and-myelofibrosis-301342839.html

    SOURCE Karyopharm Therapeutics Inc.

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  3. SHANGHAI and HONG KONG, July 13, 2021 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that it has submitted a New Drug Application (NDA) to the Taiwan Food and Drug Administration (TFDA) for selinexor, a first-in-class XPO1 inhibitor, for three indications: in combination with bortezomib and dexamethasone (XVd), or in combination with dexamethasone (Xd) for the treatment of patients with relapsed and/or refractory multiple myeloma (RRMM); and as monotherapy in adult patients with relapsed and/or refractory diffuse…

    SHANGHAI and HONG KONG, July 13, 2021 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that it has submitted a New Drug Application (NDA) to the Taiwan Food and Drug Administration (TFDA) for selinexor, a first-in-class XPO1 inhibitor, for three indications: in combination with bortezomib and dexamethasone (XVd), or in combination with dexamethasone (Xd) for the treatment of patients with relapsed and/or refractory multiple myeloma (RRMM); and as monotherapy in adult patients with relapsed and/or refractory diffuse large B-cell lymphoma (rrDLBCL), including DLBCL arising from follicular lymphoma, who have received at least two lines of systemic therapy.

    (PRNewsfoto/德琪医药有限公司)

    Antengene has submitted New Drug Applications (NDAs) for selinexor in multiple Asia Pacific markets including China, Australia, South Korea, and Singapore, and was granted Priority Review status by China's National Medical Products Administration (NMPA) and Orphan Drug Designation by the Ministry of Food and Drug Safety of South Korea (MFDS). This NDA submitted in Taiwan marks another milestone in Antengene's expansion in the APAC markets and the company's effort to address the unmet clinical needs of patients with hematologic malignancies.

    Dr. Jay Mei, Founder, Chairman and CEO of Antengene, commented: "Within just nine months, we have submitted NDAs in six APAC markets, demonstrating our commitment to addressing the unmet needs of patients in the APAC region. Our seasoned team has a wealth of experience and depth of insight in product registration and commercialization in the Asia Pacific markets. I am confident that Antengene will deliver on our promise to bring our portfolio of innovative therapies to patients in the APAC markets."

    "Selinexor is an anti-tumor drug with a highly novel mechanism of action. It has been approved by the FDA for three indications in two tumor types (MM and DLBCL) in less than two years, demonstrating its broad anti-tumor effects," said Kevin Lynch, Chief Medical Officer of Antengene. "Selinexor treatment in combination with dexamethasone still has 25.3% overall response rate (ORR) in patients who have failed five established therapies (penta-refractory) myeloma; and for patients with multiple myeloma who received at least one prior line of treatment, the median progression-free survival (PFS) is 13.9 months, which is significantly higher than that of the control group receiving bortezomib-based standard of care. In the subgroup analysis, patients who are 65 years or older, with renal insufficiency or high-risk cytogenetics can still achieve significant benefits from the XVd regimen. These are patients who are otherwise very difficult to treat. Finally, selinexor monotherapy can enable patients with rrDLBCL to obtain deep and durable responses with a median duration of response of 23.0 months for patients with complete response. We are therefore very optimistic about the potential efficacy benefits of selinexor combination regimens in DLBCL."

    Antengene and Karyopharm Therapeutics Inc. (NASDAQ:KPTI) have entered into an exclusive collaboration and license agreement for the development and commercialization of selinexor and other two XPO1 inhibitors, and a PAK4/NAMPT inhibitor in 17 APAC markets including Mainland China.

    About Selinexor (XPOVIO®)

    Selinexor, a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE) compound discovered and developed by Karyopharm, is currently being developed by Antengene, which has the exclusive development and commercial rights in certain Asia-Pacific markets, including Greater China, South Korea, Australia, New Zealand and the ASEAN countries.

    In July 2019, the US Food and Drug Administration (FDA) approved selinexor in combination with low-dose dexamethasone for the treatment of RRMM and in June 2020 approved selinexor as a single-agent for the treatment of rrDLBCL. In December 2020, selinexor also received FDA approval as a combination treatment (XVd) for MM after at least one prior therapy. In February 2021, selinexor was approved by the Israeli Ministry of Health for the treatment of patients with RRMM or rrDLBCL and in March 2021, the European Commission (EC) has granted conditional marketing authorization for selinexor (NEXPOVIO) for the treatment of adult patients with RRMM.

    Selinexor is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for the treatment of both MM and DLBCL. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene's partner, Karyopharm, presented positive results from the Phase III randomized, double blind, placebo controlled, cross-over SEAL trial evaluating single agent, oral selinexor versus matching placebo in patients with liposarcoma. Karyopharm also announced that the ongoing Phase III SIENDO trial of selinexor in patients with endometrial cancer passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) recommended the trial should proceed as planned without any modifications. Top-line SIENDO trial results are expected in the second half of 2021.

    Antengene is currently conducting five late-stage clinical trials of selinexor in China for the treatment of MM, DLBCL, non-small cell lung cancer, and peripheral T and NK/T-cell lymphoma.

    About Antengene

    Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage R&D driven biopharmaceutical company focused on innovative medicines for oncology and other life-threatening diseases. Antengene aims to provide the most advanced anti-cancer drugs to patients in the Asia Pacific Region and around the world. Since its establishment in 2017, Antengene has built a broad and expanding pipeline of clinical and pre-clinical stage assets through partnerships as well as in-house drug discovery, and obtained 15 investigational new drug (IND) approvals and submitted 6 new drug applications (NDA) in multiple markets in Asia Pacific. Antengene's vision is to "Treat Patients Beyond Borders". Antengene is focused on and committed to addressing significant unmet medical needs by discovering, developing and commercializing first-in-class/best-in-class therapeutics.

    Forward-looking statements

    The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/antengene-submits-new-drug-application-for-selinexor-in-taiwan-for-the-treatment-of-three-indications-in-hematologic-malignancies-301333212.html

    SOURCE Antengene Corporation Limited

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  4. SHANGHAI and HONG KONG, July 5, 2021 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, recently announced that China's National Medical Products Administration (NMPA) has accepted the Investigational New Drug (IND) application for single agent selinexor, a first-in-class orally available Exportin 1 (XPO1) inhibitor, for the treatment of patients with myelofibrosis (MF) in China.

    MF is a clonal hematologic neoplasm which can emerge either as primary MF, polycythemia vera (PV) or essential thrombocythemia (ET)[1]. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is currently the only curative treatment for MF. However, such treatment is difficult to carry out and has a low rate of success. According to the National Comprehensive Cancer Network (NCCN®) Guidelines for the Treatment of MF, patients with intermediate-2 or high-risk MF ineligible for allo-HSCT and with a platelet count of ≥50×109/L should be treated with ruxolitinib or fedratinib, while there are few follow-on treatment alternatives for patients failed or resistant to ruxolitinib. At present, only ruxolitinib has been approved for clinical treatment in China, and as a result, MF remains a disease with limited treatment options, representing an urgent unmet medical need.

    This randomized, open-label, multicenter Phase II study is designed to evaluate the safety and efficacy of selinexor versus physician's choice (PC) in patients with MF who had at least six months of treatment with a JAK1/2 inhibitor. Approximately 112 patients with MF from 75 trial centers across the world will be randomized in a 1:1 ratio into one of the two treatment arms.

    "This acceptance by the NMPA of the IND application for the China study of selinexor in patients with MF marks another major step forward in our effort to develop selinexor into a novel cancer drug. It also paves the way for our on-going exploration of additional indications for Antengene's novel assets," said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. "We are hopeful that, through this novel drug candidate with strong potential in this disease, coupled with our deep expertise in the field of hematologic malignancies, we will be able to bring renewed hope to patients with MF in China. Moving forward, we will work closely with the NMPA to advance this trial in China, and strive to bring this innovative therapeutic to patients in the region and beyond."

    About Selinexor (XPOVIO®)

    Selinexor is a first-in-class oral selective inhibitor of nuclear export (SINE) compound discovered and developed by Karyopharm Therapeutics Inc. (NASDAQ:KPTI), Selinexor is currently being developed by Antengene, which has the exclusive development and commercial rights in certain Asia-Pacific markets, including Greater China, South Korea, Australia, New Zealand and the ASEAN countries.

    In July 2019, the US Food and Drug Administration (FDA) approved selinexor in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma (RRMM) and in June 2020 approved selinexor as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (RR DLBCL). In December 2020, selinexor also received FDA approval as a combination treatment for multiple myeloma after at least one prior therapy. In February 2021, selinexor was approved by the Israeli Ministry of Health for the treatment of patients with RRMM or RR DLBCL and in March 2021, the European Commission (EC) has granted conditional marketing authorization for selinexor (NEXPOVIO) for the treatment of adult patients with RRMM.

    Selinexor is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for the treatment of both MM and DLBCL. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene's partner, Karyopharm, presented positive results from the Phase III randomized, double blind, placebo controlled, cross-over SEAL trial evaluating single agent, oral selinexor versus matching placebo in patients with liposarcoma. Karyopharm also announced that the ongoing Phase III SIENDO trial of selinexor in patients with endometrial cancer passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) recommended the trial should proceed as planned without any modifications. Top-line SIENDO trial results are expected in the second half of 2021.

    Antengene is currently conducting five late-stage clinical trials of selinexor for the treatment of MM, DLBCL, non-small cell lung cancer, and peripheral T and NK/T-cell lymphoma. Furthermore, Antengene has submitted New Drug Applications (NDAs) for selinexor in multiple Asia-Pacific markets including China, Australia, South Korea, and Singapore, and was granted the Priority Review status by China's NMPA and an Orphan Drug Designation by the Ministry of Food and Drug Safety of South Korea (MFDS).

    About Antengene

    Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage R&D driven biopharmaceutical company focused on innovative medicines for oncology and other life threatening diseases. Antengene aims to provide the most advanced anti-cancer drugs to patients in the Asia-Pacific Region and around the world. Since its establishment in 2017, Antengene has built a broad and expanding pipeline of clinical and pre-clinical stage assets through partnerships as well as in-house drug discovery, and obtained 15 investigational new drug (IND) approvals and submitted 5 new drug applications (NDA) in multiple markets in Asia Pacific. Antengene's vision is to "Treat Patients Beyond Borders". Antengene is focused on and committed to addressing significant unmet medical needs by discovering, developing and commercializing first-in-class/best-in-class therapeutics.

    Forward-looking statements

    The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

    [1] J. Mascarenhas, B.K. Marcellino, M. Lu, M. Kremyanskaya, F. Fabris, L. Sandy, M. Mehrotra, J. Houldsworth, V. Najfeld, S. El Jamal, B. Petersen, E. Moshier, R. Hoffman, A phase I study of panobinostat and ruxolitinib in patients with primary myelofibrosis (PMF) and post-­polycythemia vera/essential thrombocythemia myelofibrosis (post-­PV/ET MF).

     

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    SOURCE Antengene Corporation Limited

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  5. NEWTON, Mass., July 1, 2021  /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that in connection with the hiring of Ms. Sohanya Cheng, Senior Vice President, Sales and Commercial Operations, the Compensation Committee of Karyopharm's Board of Directors granted a stock option to purchase 125,000 shares of Karyopharm's common stock to Ms. Cheng, with a grant date of June 30, 2021. The stock option was granted as an inducement material to Ms. Cheng's entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).  In the event that the services of Ms. Cheng are terminated by Karyopharm without cause prior to the first…

    NEWTON, Mass., July 1, 2021  /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that in connection with the hiring of Ms. Sohanya Cheng, Senior Vice President, Sales and Commercial Operations, the Compensation Committee of Karyopharm's Board of Directors granted a stock option to purchase 125,000 shares of Karyopharm's common stock to Ms. Cheng, with a grant date of June 30, 2021. The stock option was granted as an inducement material to Ms. Cheng's entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).  In the event that the services of Ms. Cheng are terminated by Karyopharm without cause prior to the first vesting of the stock option granted to Ms. Cheng, then the number of shares underlying the stock option that is scheduled to vest on the first anniversary of Ms. Cheng's employment commencement date will vest upon her termination date.

    The Compensation Committee also granted stock options to purchase an aggregate of 50,700 shares of Karyopharm's common stock to 10 additional newly-hired employees, with a grant date of June 30, 2021. The stock options were granted as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).

    Each of the stock options has an exercise price of $10.32 per share, the closing price of Karyopharm's common stock on June 30, 2021. Each stock option vests over four years, with 25% of the total number of shares underlying the stock option vesting on the one-year anniversary of the applicable employee's employment commencement date and 1/48th of the total number of shares vesting monthly thereafter, subject to the employee's continued service as an employee of, or other service provider to, Karyopharm through the applicable vesting dates. In addition, each stock option will be immediately exercisable in full if, on or prior to the first anniversary of the consummation of a "change in control event," the employee's employment is terminated for "good reason" by the employee or terminated without "cause" by Karyopharm (as such terms are defined in the applicable stock option agreement).

    About Karyopharm Therapeutics

    Karyopharm Therapeutics Inc. (NASDAQ:KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer and other diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead 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 heavily pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. NEXPOVIO® (selinexor) has also been granted conditional marketing authorization in combination with dexamethasone for adult patients with heavily pretreated multiple myeloma by the European Commission. 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. For more information, please visit www.karyopharm.com.

    XPOVIO® and NEXPOVIO® are registered trademarks of Karyopharm Therapeutics Inc. Any other trademarks referred to in this release are the property of their respective owners.

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    SOURCE Karyopharm Therapeutics Inc.

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