Antengene announces IND approval in China for global Phase III trial of Selinexor in advanced or recurrent endometrial cancer

SHANGHAI and HONG KONG, May 13, 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 first-rate therapeutics in Hematology and Oncology, today announced that From China The National Medical Products Administration (NMPA) has approved the Investigational New Drug Application (IND) for a Phase III clinical trial designed to evaluate the safety and efficacy of selinexor (XPOVIO®) in the treatment of cancer of the advanced or recurrent endometrium (SIENDO trial).

(PRNewsfoto / 德琪 医药 有限公司)

Endometrial cancer is a common gynecologic malignancy that commonly occurs in women of childbearing age. With a high incidence rate that has steadily increased in recent years, endometrial cancer has become the most common malignancy of the female reproductive system. Pregnancy, obesity, diabetes and diseases of the reproductive system are the main risk factors for endometrial cancer[1]. There is a lack of treatment and curative care options for patients with advanced or recurrent endometrial cancer, so new and effective treatments are increasingly important.

Selinexor (XPOVIO®) is an oral selective nuclear export inhibitor approved by the United States Food and Drug Administration (FDA). included in five regimens recommended by the National Comprehensive Cancer Network (NCCN®) Guidelines and several regimens recommended by the Chinese Society of Clinical Oncology (CSCO) Diagnosis and Treatment Guidelines, for the treatment of multiple myeloma (MM) and diffuse large B cell lymphoma (DLBCL). Selinexor inhibits XPO1, the only clinically proven nuclear export protein target. Based on its unique mechanism of action, selinexor can be combined with a variety of other drugs to potentially improve efficacy. The SIENDO trial is a global trial conducted in more than 80 centers across North America, Europe and Asia.

“This IND approval for selinexor in China marks an important milestone in achieving our mission to transform patients’ lives, ”said Dr. Jay mei, founder, CEO of Antengene. “The successful launch of the SIENDO trial is a further step to help us explore other solid tumor indications for the drug candidate. We believe that selinexor has the potential to play an important role in improving treatment options for patients with endometrial cancer. We look forward to working with the sites and our partners to complete this trial. If the data is positive, we will soon make this innovative therapy available to patients of China And in the world. “

[1] Reference: Qingliang ZENG, China Maternal and Child Health, 2021,36 (08), 1723-1725 DOI: 10.19829 / j.zgfybj.issn.1001-4411.2021.08.006

About Selinexor (XPOVIO®)

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

In July 2019, the United States Food and Drug Administration (FDA) has approved selinexor in combination with low-dose dexamethasone for the treatment of relapsed / refractory multiple myeloma (rrMM) and June 2020 approved selinexor as monotherapy for the treatment of relapsed / refractory diffuse large B-cell lymphoma (rrDLBCL). In December 2020, selinexor has also received FDA approval as a combination treatment for multiple myeloma after at least one prior treatment. In February 2021, selinexor has been 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 the first and only oral SINE compound approved by the FDA to date and is the first drug approved for the treatment of MM and DLBCL. Selinexor is also being evaluated in several other mid and later phase clinical trials in several indications of solid tumors, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society (CTOS 2020) Annual Meeting 2020, Antengene’s partner, Karyopharm, presented the positive results of the SEAL randomized, double-blind, placebo-controlled, crossover phase III trial evaluating oral selinexor monotherapy versus corresponding placebo in patients with liposarcoma. Karyopharm also announced that the ongoing SIENDO Phase III trial of selinexor in endometrial cancer patients has passed the planned interim futility analysis and that the Data and Safety Monitoring Board (DSMB) has recommended that the test proceed as planned without any modification. The main results of the SIENDO trial are expected in the second half of 2021.

Antengene is currently conducting five advanced clinical trials of selinexor for the treatment of MM, DLBCL, non-small cell lung cancer, and peripheral T and NK / T lymphoma. In addition, Antengene has submitted new drug applications. (NDA) for selinexor in several Asia Pacific markets, including China, Australia, South Korea, and Singapore, and was granted priority review status by From China NMPA and an orphan drug designation by the Ministry 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 drugs for oncology and other life-threatening diseases. Antengene aims to provide the most advanced anticancer drugs to patients in the Asia-Pacific region and around the world. Since its inception in 2017, Antengene has built a large and expanding pipeline of clinical and preclinical assets through partnerships as well as in-house drug discovery, and has secured 15 Investigational New Drug Approvals (IND) and submitted 5 new drug requests (NDAs) in several markets Asia Pacific. Antengene’s vision is to “treat patients across borders”. Antengene is focused on and committed to addressing significant unmet medical needs by discovering, developing and commercializing top notch / top notch therapies.

Forward-looking statements

Forward-looking statements made in this article relate only to events or information as of the date the statements are made in this article. Except as required by law, we assume no obligation to publicly update or revise 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 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 or references to our intentions or those of any of our directors or our company are made as of the date of this article. Each of these intentions may change in the light of future development.

* XPOVIO® and NEXPOVIO® are registered trademarks of KaryopharmTherapeutics Inc.

SOURCE Antengene Corporation Limited


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