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    Home > Active Ingredient News > Drugs Articles > First nuclear output inhibitor! Deki Pharmaceutical ATG-010 (selinexor) treatment of external T and NK/T cell lymphoma completed the first patient medication!

    First nuclear output inhibitor! Deki Pharmaceutical ATG-010 (selinexor) treatment of external T and NK/T cell lymphoma completed the first patient medication!

    • Last Update: 2020-09-25
    • Source: Internet
    • Author: User
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    Antengene recently announced that the oral selective nuclear output inhibitor ATG-010 (selinexor) has completed its first phase 1b clinical trial (code name: TOUCH) in China for patients with recurring incurable external T-cell lymphoma (PTCL) and NK/T-cell lymphoma (NKTL).
    the trial was designed to assess the safety, toerability, and initial efficacy of ATG-010 (selinexor) single-drug maintenance therapy in patients with recurring recurring incurable PTCL and NKTL who had received at least one line of treatment in the past.
    is the first-in-class, selective nuclear output inhibitor (SINE).
    August 2018, Deki Pharmaceuticals and Karyopharm Therapeutics reached a strategic partnership to develop four oral innovative drugs, including three SINE XPO1 antagonists Xpovio (selinexor), eltanexor, verdinexor and a PAK4 and AMPT dual target inhibitor KPT-9274.
    January 2019, atG-010 (Xpovio) was approved for clinical approval in China for the treatment of recurring multiple myeloma, the first selective nuclear output inhibitor (SINE) developed in China for multiple myeloma.
    T-cell lymphoma and NK/T-cell lymphoma are lymphocytes derived from T-cells and NK cell line, and there are significant regional differences in disease distribution.
    PTCL accounts for about 25%-30% of non-Hodgkin's lymphoma (NHL) in China.
    NKTL is closely related to Epstein-Barr virus infection, accounting for about 6.4 percent of China's NHL and 24.91 percent of T-cell NHL.
    PTCL and NKTL are significantly higher in China's NHL than in Europe and the United States.
    at present, first-line chemotherapy programs based on cyclocycline and mendonamidease have limited efficacy for PTCL and NKTL, and there is no standard second-line treatment for patients with relapse or recurring treatment.
    ATG-010 (selinexor) is an oral, selective nuclear output inhibitor that can cause in-nucleus retention and resuspension of tumor suppressors and other growth-regulating proteins, as well as reduce a variety of carcinogenic proteins, and induce apoptosis of large numbers of solid and blood tumor cells in vitro and in vivo, while normal cells are not affected.
    clinical studies have shown that ATG-010 (selinexor) is effective and safe for a variety of hematomas and solid tumors.
    , the ATG-010 (selinexor) is the first and only FDA-approved SINE compound.
    Deqi Pharmaceuticals is conducting Phase 2 registered clinical studies in China for attestable recurring multiple myeloma and refractic recurring large B-cell lymphoma in China, and has initiated clinical trials on high-risk tumors in the Asia-Pacific region, including T-cell lymphoma and KRAS mutant non-small cell lung cancer. "PTCL and NKTL are highly heterogeneic and invasive, existing treatment options are ineffective and have poor prognosis, so there is still a significant number of unmet clinical needs for patients with relapses, especially those with multiple comorbations that are not suitable for transplantation, and there is an urgent need to develop new treatments," said Dr. Jianming Mei, founder, chairman and CEO of
    Deqi Pharmaceuticals.
    trials have shown that ATG-010 monotherapy is effective for solid and hematomas, and that it has significant synergies with a variety of chemotherapy and targeted therapies.
    through a combination of companies and complementary clinical strategies, ATG-010 promises to bring a new and effective treatment to this group of patients.
    " selinexor (Xpovio) is a pioneering, oral, selective nuclear output inhibitor (SINE) compound that binds and inhibits the function of the nucleoprotein XPO1 (also known as CRM1), which causes tumor inhibitors to accumulate in the nuclei of the cell, which restarts and amplifies their tumor suppression function, resulting in selective apoptosis of cancer cells without significantly affecting normal cells.
    in the United States, selinexor (Xpovio) has been approved by the FDA for 2 tumor adaptations for the treatment of pentovirus multiple myeloma (MM) and recurring or refractic diffuse large B-cell lymphoma (DLBCL), specifically: (1) joint Dexamisson, used in patients who have received at least 4 therapies in the past and have at least 2 protease inhibitors (PI), at least 2 immunosuppressants (IMiDs), and an anti-CD38 monoclonal antibody that is difficult to treat in patients with recurring multiple myeloma (RRMM).
    (2) is used to treat adult patients with relapsed or incurable DLBCL who have received at least 2 system therapies, including DLCBL caused by folytic lymphoma (FL).
    it's worth noting that Xpovio is the first and only FDA-approved nuclear output inhibitor (SINE) to be approved for a new target for myeloma (XPO1) since 2015.
    addition, Xpovio is the first single-drug oral therapy approved for the treatment of relapsed or incurable DLBCL.
    July, the FDA accepted a new drug application (sNDA) from Xpovio seeking approval for a new adaptation for patients with multiple myeloma (MM) who had previously received at least one treatment.
    FDA expects to make a review decision by the end of the first quarter of 2021.
    if this sNDA is approved, Xpovio will provide an important complement to the treatment model for patients with relapsed or incurable MM.
    Currently, Karyopharm is evaluating the potential of selinexor to treat a range of hematosomas and solid tumors in a number of late-stage clinical studies, including multiple myeloma (MM), diffuse large B-cell lymphoma (DLBCL), liposarcoma (SEAL study), endometrial cancer, and relapsed glioblastoma.
    .
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