Antengene obtains IND approval in China for phase Ib study of ATG-008 (Onatasertib) in combination with ATG-010 (Selinexor) in patients with diffuse large B-cell lymphoma


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SHANGHAI and HONG KONG, November 2, 2021 / PRNewswire / – Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to the discovery, development and commercialization of world-leading and / or world-leading therapeutics Order in Hematology and Oncology, today announced that from China The National Medical Products Administration (NMPA) has approved an open label phase Ib dose escalation study designed to evaluate the safety of ATG-008 (onatasertib) in combination with ATG-010 (selinexor) in patients with cell lymphoma (rrDLBCL).

(PRNewsfoto / Antengene Corporation Limited)

This study will be carried out in ten centers across China, including its main testing center at Sun Yat-Sen University Cancer Center. Composed of a dose escalation phase and a dose extension phase, the study will recruit patients with rrDLBCL and treat these patients with the combination of ATG-008 and ATG-010, in the goal of determining the recommended dose of ATG-008 plus ATG-010 while further evaluating the safety and efficacy of the combination regimen.

ATG-008 is a potent and selective mammalian target inhibitor of rapamycin (mTOR) capable of dual inhibition of mTORC1 and mTORC2. In several hematologic malignancy cell lines, including 23 DLBCL cell lines, ATG-008 has been shown to suppress cell proliferation and induce apoptosis. In animal models of the OCI-LY10 (ABC) activated human DLBCL cell line xenograft, ATG-008 at 3 mg / kg and 10 mg / kg exhibited potent anti-tumor activity as a sole agent. ATG-010 is a potent first-order selective nuclear export inhibitor (SINE) that has demonstrated broad spectrum antitumor activity in multiple hematologic malignancies and solid tumors. The United States Food and Drug Administration (FDA) has approved selinexor as monotherapy for the treatment of relapsed / refractory diffuse large B-cell lymphoma (rrDLBCL).

Teacher. Qingqing Cai, doctoral director at Sun Yat-Sen University Cancer Center, chairman of the Lymphoma Group, oncology subcommittee of the Guangdong Medical Association, and principal investigator of the study, noted, “LDGCB is one of the most common subtypes of non-Hodgkin lymphoma, 30% to 40% of patients will eventually relapse or become refractory. an urgent need for safer and more effective treatment options with novel mechanisms of action to achieve prolonged progression-free survival and improved quality of life In preclinical studies of the DoHH-2 cell line and models mouse DoHH2 CDX, ATG-008 plus ATG-010 has demonstrated potent synergistic antitumor activity both in vivo and in vitro, giving us confidence in the further study of the synergistic effect of ATG-008 and ATG-010 in the DLBCL. “

Dr. Jay mei, Founder, Chairman and CEO of Antengene, commented, “We are delighted to have received this approval from NMPA for the open label phase Ib dose escalation study designed to evaluate the safety of ATG-008 plus ATG-010 in patients with of rrDLBCL, as it marks an important milestone for Antengene. ATG-008 and ATG-010 have demonstrated strong anti-tumor activity as sole agents in preclinical models of DLBCL, and selinexor has been approved by the United States Food and Drug Administration for clinical use in this indication. Hopefully, the combination of these agents will demonstrate synergies with enhanced efficacy as a combination therapy for the treatment of rrDLBCL. We hope that the combination of ATG-008 and ATG-010 will benefit rrDLBCL patients worldwide. “

About the MATCH study

This open-label, dose-escalating phase Ib study is designed to evaluate the safety of ATG-008 (onatasertib) in combination with ATG-010 (selinexor) in adult patients with relapsed diffuse large B-cell lymphoma / refractory (rrDLBCL). The primary endpoints of the study include the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of ATG-008 plus ATG-010 in patients with rrDLBCL. The secondary endpoint is the lymphoma response assessed according to the modified Lugano response criteria (Cheson 2014).

About Antengène

Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading 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 starting operations in 2017, leveraging partnerships and in-house drug deliveries, Antengene has built a large and expanding pipeline of clinical and preclinical assets. Now, Antengene has 13 research assets, including 8 global rights assets and 5 assets with research rights. Asia Pacific markets including Greater China Region. Antengene obtained 18 Investigational New Drug Approvals (INDs), submitted 6 New Drug Applications (NDAs) in several Asia Pacific markets, with the NDA for selinexor in South Korea already approved through a priority review process. Driven by his vision of ‘Tpatients across borders“, Antengene is committed to meeting significant unmet medical needs by discovering, developing, manufacturing and marketing first-class / best-in-class therapeutic products.

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 unforeseen events. events. You should read this article in its entirety 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.

SOURCE Antengene Corporation Limited

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