ANTENGENE CORPORATIO

6996
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Antengene : VOLUNTARY ANNOUNCEMENT NMPA APPROVAL OF IND APPLICATION FOR A PHASE IB/II CLINICAL TRIAL OF ELTANEXOR IN ADVANCED SOLID TUMORS

05/14/2021 | 10:39am

Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement.

Antengene Corporation Limited

德琪醫藥有限公司

(Incorporated in the Cayman Islands with limited liability)

(Stock Code: 6996)

VOLUNTARY ANNOUNCEMENT

NMPA APPROVAL OF IND APPLICATION FOR A PHASE IB/II CLINICAL

TRIAL OF ELTANEXOR IN ADVANCED SOLID TUMORS

Antengene Corporation Limited (the "Company", together with its subsidiaries, the "Group") hereby informs the shareholders and potential investors of the Company of the attached press release that the Company has received the approval of the investigational new drug ("IND") application by the National Medical Products Administration ("NMPA") for a Phase IB/II clinical trial of Eltanexor in advanced solid tumors in China.

This is a voluntary announcement made by the Company. The Group cannot guarantee that Eltanexor will ultimately be successfully developed and marketed. Shareholders and potential investors of the Company are advised to exercise caution when dealing in the shares of the Company.

By order of the Board

Antengene Corporation Limited

Dr. Jay Mei

Chairman

Hong Kong, May 14, 2021

As at the date of this announcement, the board of directors of the Company comprises Dr. Jay Mei, Mr. John F. Chin and Mr. Yiteng Liu as executive directors; Mr. Yanling Cao, Mr. Zhen Li and Dr. Kan Chen as non-executive directors; and Mr. Mark J. Alles, Ms. Jing Qian and Mr. Sheng Tang as independent non-executive directors.

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Antengene Announces the IND Approval for Eltanexor in Patients with Advanced Solid Tumors in Mainland China

Shanghai and Hong Kong, PRC, May 14, 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 that China's National Medical Products Administration (NMPA) has approved the initiation of a Phase Ib/II open-label, multicenter, dose-escalation study of eltanexor (ATG-016) in patients with advanced solid tumors (the REACH study).

This study aims to assess the safety and efficacy of eltanexor monotherapy in patients with advanced solid tumors. The Phase Ib part of the study will be carried out in patients with advanced solid tumors, including those with KRAS-mutant, p53 wild-type, human papillomavirus (HPV)- associated, Epstein-Barr virus (EBV)-positive and other solid tumors; and the Phase II part of the study will enroll patients with recurrent or metastatic penile squamous cell carcinoma, and patients with recurrent or metastatic nasopharyngeal carcinoma.

Eltanexor is a next-generation selective inhibitor of nuclear export (SINE) compound which exerts antitumor effects by inhibiting the nuclear export protein XPO1 leading to the accumulation and activation of tumor suppressor proteins in the nucleus, while simultaneously blocking the expression and translation of oncogenic proteins. For cancer patients, high XPO1 expression is commonly associated with a poor prognosis and resistance to chemotherapies. Pre-clinical data showed that eltanexor has potent pro-apoptotic activity in a broad spectrum of tumor cells without affecting normal cells. Moreover, eltanexor has also showed potent antitumor activity in animal models with multiple solid tumors including hepatocellular carcinoma, prostate cancer, pancreatic cancer, colon cancer and breast cancer.

"This IND approval marks an important step for Antengene's clinical development of eltanexor, one that we hope will ultimately allow patients with solid tumors to benefit from eltanexor's novel mechanism of action," said Dr. Jay Mei, founder, chairman and CEO of Antengene. "Based on the compelling pre-clinical and clinical data, eltanexor monotherapy has the potential of bringing renewed hope and higher quality of life to patients with advanced solid tumors in China."

About Eltanexor (ATG-016)

Eltanexor is a next-generation selective inhibitor of nuclear export (SINE) compound. Compared to the first-generation SINE compound, eltanexor has lower blood-brain barrier penetration and broader therapeutic window which allows more frequent dosing and a longer period of exposure at higher levels with better tolerability. Therefore, eltanexor may be used to target a broader range of indications. Antengene is currently conducting clinical trials of eltanexor in patients with myelodysplastic syndrome (MDS) or advanced solid tumors in China.

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About Antengene

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage R&D driven biopharmaceutical company focused on innovative medicines for oncology and other life threatening diseases. Antengene aims to provide the most advanced anti-cancer drugs to patients in the Asia Pacific Region and around the world. Since its establishment in 2017, Antengene has built a broad and expanding pipeline of clinical and pre-clinical stage assets through partnerships as well as in-house drug discovery, and obtained 15 investigational new drug (IND) approvals and submitted 5 new drug applications (NDA) in multiple markets in Asia Pacific. Antengene's vision is to "Treat Patients Beyond Borders". Antengene is focused on and committed to addressing significant unmet medical needs by discovering, developing and commercializing first-in-class/best-in-class therapeutics.

Forward-looking statements

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly 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 unanticipated 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 of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

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Disclaimer

Antengene Corporation Ltd. published this content on 14 May 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 14 May 2021 14:38:14 UTC.

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