Antengene submitted IND application for Xpovio to treat rrMM & rrDLBCL

Antengene Corporation

Antengene Corporation Limited, a number one innovative biopharmaceutical company, announced it’s submitted new drug applications (NDA(s)) for Xpovio (selinexor, ATG-010) to the Health Sciences Authority of Singapore and to the Australian Therapeutic Goods Administration (TGA) for 3 indications: the treatment of adult patients with relapsed or refractory myeloma (rrMM) who have received a minimum of four prior therapies and whose disease is refractory to a minimum of two proteasome inhibitors, a minimum of two immunomodulatory agents, and an anti-CD38 antibody ; and together with bortezomib and dexamethasone for the treatment of patients with myeloma who have received a minimum of one prior line of therapy; and for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after a minimum of two lines of systemic therapy. Australian Therapeutic Goods Administration has accepted the NDA of Antengene on December 2, 2020.

A new drug application (NDA) for Xpovio (selinexor) has also been submitted to the Hong Kong Department of Health for the treatment of adult patients with rrMM who have received a minimum of four prior therapies and whose disease is refractory to a minimum of two proteasome inhibitors, a minimum of two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

In South Korea , Xpovio (selinexor) has been granted orphan drug designation for the treatment of adult patients with rrMM who have received a minimum of four prior therapies and whose disease is refractory to a minimum of two proteasome inhibitors, a minimum of two immunomodulatory agents, and an anti-CD38 antibody and for the treatment of adult patients with rrDLBCL, not otherwise specified, including DLBCL arising from follicular lymphoma, after a minimum of two lines of systemic therapy.

Xpovio (selinexor, ATG-010) may be a first-in-class and only-in-class oral selective inhibitor of nuclear export, developed by Antengene and Karyopharm Therapeutics Inc. In July 2019, the US Food and Drug Administration (FDA) approved Xpovio (selinexor) together with low-dose dexamethasone for the treatment of rrMM. After its initial approval of rrMM, FDA approved Xpovio (selinexor) as a single-agent for the treatment of rrDLBCL in June 2020.

In November 2020, at the animal tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene’s partner, Karyopharm Therapeutics, presented positive results from the Phase 3 portion of the randomized, test , placebo controlled, cross-over SEAL study evaluating single agent, oral Xpovio (selinexor) versus matching placebo in patients with liposarcoma. Karyopharm also recently announced that the continued phase 3 SIENDO study of Xpovio (selinexor) in patients with endometrial carcinoma passed planned interim futility analysis which Data and Safety Monitoring Board (DSMB) recommended the study should proceed as planned with none modifications. Top-line SIENDO study results are expected within the last half of 2021.

Xpovio may be a first-in-class and only-in-class oral selective inhibitor of nuclear export compound, developed by Antengene and Karyopharm Therapeutics Inc. In July 2019, the US Food and Drug Administration (FDA) approved Xpovio together with low-dose dexamethasone for the treatment of relapsed or refractory myeloma (rrMM) and in June 2020 approved Xpovio as a single-agent for the treatment of relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL). Xpovio is thus far the primary and only oral SINE compound approved by the FDA. Xpovio is additionally being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial carcinoma .

Antengene is conducting two registrational phase 2 clinical trials of Xpovio in China for relapsed refractory myeloma (MARCH) and for relapsed refractory diffuse large B-cell lymphoma (SEARCH), and has initiated clinical trials for top prevalence cancer types within the Asia Pacific region including peripheral T-cell lymphoma and NK/T-cell lymphoma (TOUCH) and KRAS-mutant non-small cell carcinoma (TRUMP).

Antengene Corporation Limited may be a leading clinical-stage Asia-Pacific biopharmaceutical company focused on innovative oncology medicines. Antengene aims to supply the foremost advanced anti-cancer drugs to patients in China, the Asia Pacific Region and round the world.

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