SHANGHAI and HONG KONG, Nov. 25,
2020 /PRNewswire/ -- Antengene Corporation Limited
("Antengene", HKSE stock code: 6996.HK), a leading innovative
biopharmaceutical company dedicated to discovering, developing and
commercializing global first-in-class and/or best-inclass
therapeutics in hematology and oncology, announced that the
National Medical Products Administration (NMPA) has approved the
clinical trial of ATG-016 (eltanexor) in patients with intermediate
and higher risk myelodysplastic syndrome (MDS) according to the
Revised International Prognostic Scoring System (IPSS-R) after the
failure of hypomethylating agents (HMA) based therapy. The trial is
a Phase I/II, single-arm, open-label clinical study, aiming to
evaluate the pharmacokinetics, safety and efficacy of ATG-016
(eltanexor) monotherapy.
MDS is a heterogeneous group of clonal disorders of the bone
marrow hematopoietic stem cells (HPSCs), characterized by
ineffective hematopoiesis with peripheral blood cytopenia and a
higher risk for developing acute myeloid leukemia (AML). Patients
with high-risk MDS refractory to hypomethylating agents have a
median overall survival (OS) of only 4 to 6 months with limited
options for follow-up treatment. Pre-clinical studies have
demonstrated that selective inhibitor of nuclear export (SINE)
compounds are able to block the nuclear export of many tumor
suppressor proteins (e.g. p53, IkB, p21) leading to their
accumulation and activation in the nucleus thereby exerting
anti-tumor effects. In addition, SINE compounds can also reduce the
nuclear export and translation of many oncogenic mRNA (c-Myc,
Bcl-2, Bcl-6, cyclin D) which are bound to elF4E and result in
selective apoptosis of tumor cells. ATG-016 is a member of the
latest-generation of SINE compounds. Compared to the
first-generation nuclear export inhibitor, ATG-016 demonstrates
minimal blood-brain barrier permeability and a broader therapeutic
window. It has shown preliminary anti-cancer activity in high-risk
MDS patients.
Dr. Jay Mei, the Founder,
Chairman and CEO of Antengene expressed, "The approval of the
ATG-016 clinical trial demonstrates the efficient execution of the
Antengene R&D team and is also the first clinical trial
approval obtained by Antengene in mainland China after its listing." He also mentioned,
"Selinexor, the first-generation selective inhibitor of nuclear
export, has shown extensive activity against hematological
malignancies and solid tumors, and has been approved by the FDA for
relapsed/refractory multiple myeloma and diffuse large B-cell
lymphoma. As a second-generation orally available SINE compound,
ATG-016 can reduce the blood-brain barrier penetration, thereby
representing a broader therapeutic window with potentially less
adverse events and better drug tolerability."
About ATG-016
ATG-016 (eltanexor) is a second-generation selective inhibitor
of nuclear export compound. Compared to the first-generation SINE
compound, ATG-016 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, ATG-016 may be used to target a wider
range of indications. We plan to conduct phase I/II clinical
studies for MDS in China, and plan
to further develop ATG-016 for cancers with high prevalence in the
Asia-Pacific region (such as
KRAS-mutant solid tumors) and virus infection related malignancies
(such as nasopharyngeal carcinoma).
About Antengene
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a
leading clinical-stage Asia-Pacific biopharmaceutical company focused
on innovative oncology medicines. Antengene aims to provide the
most advanced anti-cancer drugs to patients in China, the Asia Pacific Region and around the
world. Since its establishment, Antengene has built a pipeline of
12 clinical and pre-clinical stage assets, obtained 10
investigational new drug (IND) approvals and has 9 ongoing
cross-regional clinical trials in Asia
Pacific. At Antengene, we focus on developing drug
candidates with novel mechanisms of action (MoAs) and
first-in-class/best-in-class potential to address significant unmet
medical needs. The vision of Antengene is to "Treat Patients Beyond
Borders" through research, development and commercialization of
first-in-class/best-in-class therapeutics.
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no obligation to update or revise publicly any forward-looking
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or otherwise, after the date on which the statements are made or to
reflect the occurrence of unanticipated events. You should read
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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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SOURCE Antengene Corporation Limited