SHANGHAI and HONG KONG, January 4, 2021 / PRNewswire / – Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to the discovery, development and commercialization of world-class and / or world-class therapeutics in hematology and oncology, announced that that it has filed an Investigational New Drug (IND) application with the National Medical Products Administration (NMPA) for ATG-010 (Selinexor) for the treatment of endometrial cancer. This is a Phase 3, multicentre, double-blind, randomized, global study (SIENDO) aimed at evaluating the effectiveness of ATG-010 versus placebo as maintenance therapy in patients with advanced or recurrent endometrial cancer after combination chemotherapy 80 investigative agencies around the world, underneath North America, Europe and Asia.
Endometrial cancer is the most common type of cancer in the female reproductive tract. Treatment options with poor prognosis are limited for patients who progress after initial chemotherapy. The highest incidence rates are reported in developed countries and some economically developed areas of China. In recent years, with the increase in the prevalence of obesity, diabetes and high blood pressure, the incidence and mortality rate of endometrial cancer has increased with the trend toward younger women.
ATG-010 is a premier and only oral selective inhibitor of nuclear export developed by Antengene and Karyopharm Therapeutics Inc. (NASDAQ: KPTI). It has been approved by the US Food and Drug Administration (FDA) for use in both multiple myeloma and diffuse large B-cell lymphoma, which are two main indications for hematological malignancies. In addition, the Phase 3 SIENDO study of ATG-010 in patients with endometrial cancer passed the planned preliminary futility analysis and the Data and Safety Monitoring Board (DSMB) recommended that the study continue as planned without changes.
“The positive data from the Phase 3 SEAL study in liposarcomas and the ongoing Phase 3 SIENDO study in endometrial cancer, which have just passed the interim analysis, indicate significant potential for ATG-010 in multiple solid tumors. Submission of an IND at the NMPA in China is an important step in the clinical development of ATG-010 as we expect to explore additional therapeutic areas of our novel oral drug Candidate,” said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. “We look forward to entering the global phase 3 study in patients with advanced or recurrent endometrial cancer Chinato provide better treatment options for Chinese patients. “
Professor Qi Zhou from the Gynecological Oncology Center of Chongqing University Cancer Hospital, the lead clinical investigator, said, “R&D ability in China has improved significantly in recent years. There are more innovative anti-tumor drugs moving towards clinical research and commercialization, and they are widely used in clinical practice. The advent of targeted and immunotherapeutic drugs effectively improved patient prognosis. I look forward to advancing research on ATG-010, a world-class selective nuclear export inhibitor, with Antengen to improve efficacy and improve treatment accessibility so that patients can benefit from clinical results as soon as possible. “”
About ATG-010 (Selinexor, XPOVIO®)
ATG-010 (Selinexor, XPOVIO®), a premium and unique oral selective inhibitor of the nuclear export compound discovered and developed by Karyopharm, is currently being developed by Antengene, which has exclusive development and commercial rights in certain Asia Pacific Markets, including the Greater China, South Korea, Australia, New Zealand and the ASEAN countries. in the July 2019The US Food and Drug Administration (FDA) has approved ATG-010 in combination with low-dose dexamethasone for the treatment of relapsed / refractory multiple myeloma (rrMM) and in June 2020 Approved ATG-010 as a single agent for the treatment of relapsed / refractory diffuse large B-cell lymphoma (rrDLBCL). A Marketing Authorization Application (MAA) has also been submitted to the European Medicines Agency (EMA) with the application for conditional approval of ATG-010 in the same rrMM indication. On December 18, 2020The supplementary New Drug Application (sNDA), which requests an extension of its indication to the treatment of patients with multiple myeloma after at least one previous therapy, has been approved by the FDA. ATG-010 is the first and only SINE oral compound to be approved by the FDA, and the first drug approved for the treatment of both MM and DLBCL. ATG-010 is also being evaluated in several other mid- and later-phase clinical trials across several solid tumor indications, including liposarcoma and endometrial cancer. in the November 2020At the annual meeting of the Connective Tissue Oncology Society 2020 (CTOS 2020), Antengenes partner Karyopharm presented positive results from the randomized, double-blind, placebo-controlled, cross-over-SEAL phase 3 study, in which an oral ATG-010 single active ingredient compared to the matching placebo was evaluated in patients with liposarcoma. Karyopharm recently announced that the ongoing SIENDO Phase 3 study of ATG-010 in patients with endometrial cancer has passed the planned preliminary futility analysis, and the Data and Safety Monitoring Board (DSMB) recommended that the study continue as planned without changes. The best results of the SIENDO study are expected in the second half of 2021.
Antengen is conducting two Phase 2 clinical registration studies with ATG-010 in China for Relapsed / Refractory Multiple Myeloma (MARCH) and Relapsed / Refractory Diffuse Large B-Cell Lymphoma (SEARCH) and has initiated clinical trials for high-prevalence cancers in the United States Asia Pacific Region including peripheral T-cell lymphoma and NK / T-cell lymphoma (TOUCH) and KRAS mutated non-small cell lung cancer (TRUMP).
Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading clinical stage Asia Pacific The biopharmaceutical company focused on innovative oncological drugs. Antengene aims to bring the most advanced cancer drugs to patients in the United States China, in Asia Pacific and around the world. Since inception, Antengene has built a pipeline of 12 clinical and preclinical assets and received 11 new investigational drug approvals Asia Pacific. Antengen’s vision is to “Treat Patients Beyond Boundaries”. Antengene aims to meet the significant medical needs by discovering, developing and commercializing world class / world class therapeutics.
The forward-looking statements made in this article relate only to events or information at the time the statements in this article are made. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements as a result of new information, future events, or for any other reason after the date on which the statements were made, or to reflect the occurrence of unexpected events. You should read this article in its entirety and understand that our actual future results or performance could differ materially from our expectations. This article makes statements or references as of the date of this article about our intentions or those of our directors or our company. Each of these intentions can change in the light of future developments.
* XPOVIO® is a registered trademark of Karyopharm Therapeutics Inc.
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