SHANGHAI, China and PHILADELPHIA, U.S. — September 14, 2020 — Antengene Corporation, a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapies in oncology and hematology, announced today that it has dosed the first patient in a phase Ib clinical trial in China with ATG-010 (selinexor)，an oral selective inhibitor of nuclear export (SINE) compound，for the treatment of relapsed or refractory Peripheral T-cell Lymphoma (PTCL) and NK/T-cell Lymphoma (NKTL) (TOUCH trial). This trial aims to evaluate ATG-010 (selinexor) combined with ICE regimen or GEMOX regimen and sequential ATG-010 (selinexor) monotherapy maintenance to evaluate the safety, tolerability and primary efficacy in patients with R/R PTCL and NKTL who have received at least one prior multi-agent therapy.
PTCL and NKTL are lymphoid malignancies derived from T-cell and NK-cell lineages, respectively, with significant regional differences in disease distribution. PTCL accounts for approximately 25-30% of NHL in China. NKTL is closely related to Epstein-Barr virus infection, accounting for approximately 6.4% of NHL and 24.91% of T-cell NHL in China. The respective proportion of PTCL and NKTL in NHL in China is significantly higher than that in Europe and the United States. However, the anthracycline-based and asparaginase-based regimens for PTCL and NKTL have limited efficacy, and there is no standard second-line therapy for the relapsed or refractory patients.
ATG-010 (selinexor) is an oral selective inhibitor of nuclear export (SINE) compound. It induces the apoptosis of solid and hematological tumor cells in vitro and in vivo by causing the nuclear storage and activation of tumor suppressor proteins and other growth-regulating proteins, and by down-regulating the intracytoplasmic levels of various oncogenic proteins while normal cells are not affected. Clinical studies have demonstrated that ATG-010 (selinexor) has clinical effects on several kinds of hematological and solid tumors with manageable safety profile.
“PTCL and NKTL are highly heterogeneous and highly invasive diseases. The existing therapeutic regimens have poor outcomes and prognosis. Therefore, for patients with relapsed and refractory diseases, especially for many elderly patients and/or patients with multiple comorbidities who are not suitable for transplantation, there is still a large number of unsatisfied and unmet clinical needs, and there is an urgent need to develop new therapies.” said Dr. Jay Mei, Founder, Chairman and CEO of Antengene, “Clinical studies have demonstrated that monotherapy of ATG-010 is active in multiple solid tumor types and hematological malignancies and its combination with various chemotherapy or targeted therapies has significant synergistic effects. Through our company’s combinatory and complementary approach in clinical development, ATG-010 is expected to provide a novel and effective therapeutic regimen for those patients.”
ATG-010 (selinexor) is a first-in-class and only-in-class oral selective inhibitor of nuclear export compound, developed by Antengene and Karyopharm Therapeutics Inc. (Nasdaq: KPTI). In July 2019, the US Food and Drug Administration (FDA) approved selinexor in combination with low-dose dexamethasone for the treatment of relapsed or refractory multiple myeloma (R/R MM) and in June 2020 approved selinexor as a single-agent for the treatment of relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). ATG-010 (selinexor) is so far the first and only oral SINE compound approved by the FDA. Antengene is conducting two registrational phase II clinical trials of ATG-010 (selinexor) in China for R/R MM and R/R DLBCL, and has initiated clinical trials for high prevalence cancer types in the Asia Pacific region (including T-cell lymphoma and KRAS-mutant non-small cell lung cancer (NSCLC)).