Shanghai and Hong Kong, PRC, January 25, 2021-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, announced today that the National Medical Products Administration (NMPA) has granted approval for the Investigational New Drug (IND) application for ATG-010 (selinexor) combined with R-GDP (SR-GDP) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). The trial is a global Phase 2/3, multicenter study aiming to evaluate the safety and efficacy of ATG-010 in combination with R-GDP (SR-GDP) in patients with rrDLBCL (XPORT-DLBCL-030). It will be conducted at multiple international centers located in China, U.S., Australia, Europe and other regions.
ATG-010 (selinexor) is the first oral selective inhibitor of nuclear export (SINE) product in the world. It induces the apoptosis of cancer cells in vitro and in vivo by causing the nuclear storage and activation of tumor suppressor proteins and other growth-regulating proteins, and by down-regulating the intracytoplasmic levels of various oncogenic proteins while normal cells are not affected. In June 2020, the US Food and Drug Administration (FDA) approved ATG-010 as a single-agent for the treatment of rrDLBCL. This is the second indication for ATG-010 in hematological malignancies and the treatment regimen has been added to the National Comprehensive Cancer Network (NCCN®) Guidelines. In China, Antengene is conducting a Phase 2 clinical trial of ATG-010 in the treatment of patients with rrDLBCL who have received at least two but no more than five previous systemic regimens.
“Being granted the trial approval by the NMPA bears great significance as it brings us a step closer to offering an optimized new oral therapy to patients with DLBCL who now have very limited treatment options,” said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. “As the first global multicenter trial we are taking part in this year, the study once again signifies the advantages of our globalized development strategies. We will collaborate seamlessly with our global partners to ensure the successful initiation of the trial in China.”
About ATG-010 (selinexor, XPOVIO®)
ATG-010 (selinexor, XPOVIO®), a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE) compound discovered and developed by Karyopharm Therapeutics Inc. (NASDAQ: KPTI), 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 (XPOVIO®) in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma (rrMM) and in June 2020 approved selinexor (XPOVIO®) as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). In December 2020, selinexor (XPOVIO®) also received FDA approval as a combination treatment for multiple myeloma after at least one prior therapy. A Marketing Authorization Application (MAA) has also been submitted to the European Medicines Agency (EMA) with a request for conditional approval of selinexor in this same rrMM indication. Selinexor (XPOVIO®) 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 (XPOVIO®) 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 3 randomized, double blind, placebo controlled, cross-over SEAL trial evaluating single agent, oral selinexor (XPOVIO®) versus matching placebo in patients with liposarcoma. Karyopharm also recently announced that the ongoing Phase 3 SIENDO trial of selinexor (XPOVIO®) 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 Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading clinical-stage Asia-Pacific biopharmaceutical company focused on innovative oncology medicines. Antengene aims to provide the most advanced anti-cancer drugs to patients in China, the Asia Pacific Region and around the world. Since its establishment, Antengene has built a pipeline of 12 clinical and pre-clinical stage assets, obtained 12 investigational new drug approvals and has 9 ongoing cross-regional clinical trials in Asia Pacific. The vision of Antengene is to “Treat Patients Beyond Borders”. Antengene aims to address significant unmet medical needs by discovering, developing and commercializing first-in-class/best-in-class therapeutics.
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* XPORT-DLBCL-030 was initiated by Karyopharm Therapeutics Inc.; XPOVIO® is a registered trademark of Karyopharm Therapeutics Inc.; R-GDP: Rituximab, Gemcitabine, Dexamethasone and Cisplatin.