Le Lézard
Classified in: Health, Science and technology
Subjects: TRI, IMA

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


SHANGHAI and HONG KONG, May 13, 2021 /PRNewswire/ -- 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.

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.

SOURCE Antengene Corporation Limited


These press releases may also interest you

at 20:00
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today...

at 19:35
Prestige BioPharma Limited (PBP) specializing in the development of antibody therapeutics, announced that French National Agency for the Safety of Medicines and Health Products (L'Agence nationale de sécurité du medicament, ANSM) has approved a Phase...

at 18:01
COVID-19 patients suffer from cognitive and behavioural problems two months after being discharged from hospital, a new study presented at the 7th Congress of the European Academy of Neurology has found[1]. Issues with memory, spatial awareness...

at 17:37
The Government of Canada will announce updates to the border measures implemented to protect the health of Canadians due COVID-19. Ministers will hold a news conference to announce updates to border measures. Ministers will be available to answer...

at 12:00
I would like to dedicate today's Sunday Edition to a special group who have shown great strength and courage during a very challenging period - the kids and teens across Canada, and to the adults who support them. I know that things have not been...

at 11:00
The most recent data on the evolution of COVID-19, in the last 24 hours, in Québec show: 103 new cases, bringing the total number of people infected to 373,921; 361,352 people have recovered; 2 new deaths, for a total of 11,191 deaths: 0 deaths in...



News published on 13 may 2021 at 20:40 and distributed by: