Aug 07, 2018
NEWTON, Mass. and SHANGHAI, China – Aug 7, 2018 – Antengene Corporation’s Strategic Partner Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for selinexor, its novel, oral SINE compound, as a new treatment for patients with penta-refractory multiple myeloma. Patients with penta-refractory myeloma have previously received the two proteasome inhibitors (PIs), Velcade® (bortezomib) and Kyprolis® (carfilzomib), the two immunomodulatory drugs (IMiDs), Revlimid® (lenalidomide) and Pomalyst® (pomalidomide), and the anti-CD38 monoclonal antibody Darzalex® (daratumumab) as well as alkylating agents, and their disease is refractory to at least one PI, at least one IMiD, Darzalex and their most recent therapy.
“There is a substantial urgency for new therapies with novel mechanisms for patients with highly resistant, penta-refractory myeloma,” said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. “The completion of our first NDA submission marks a significant achievement for Karyopharm and brings oral selinexor one step closer to these patients. We are sincerely grateful to the patients, caregivers and investigators that have contributed to the selinexor program to date, the Agency for working with us with a sense of urgency and support, and to the entire Karyopharm team for their inexhaustible professionalism and dedication to advancing this NDA.”
“We are very glad that Selinexor (ATG-010) has completed the submission of New Drug Application to U.S. Food and Drug Administration in such a short period of time, which fully reflects the sufficient clinical data in the early stage of the project and the recognition of Drug Administration. We congratulate on this and feel that ATG-010 is a step closer to Chinese patients.” said Dr. Jay Mei, founder, chairman, and CEO of Antengene. “We appreciate colleagues of Karyopharm and Antengene for their efforts in the project development process. Next, Antengene will accelerate the application of ATG-010 in China. With the foundation of seamless cooperation and Antengene team’s intensive and in-depth communication with domestic Food and Drug Administration and hematology oncologists (KOL) in recent two months, our pace of listing in China will be further accelerated”
Selinexor (ATG-010) plans to be approved and put on the market by the US Food and Drug Administration (FDA) in the first half of 2019. At the same time, Karyopharm also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2019 with a request for conditional approval.
In May 2018, Antengene and Karyopharm Therapeutics entered into a broad strategic partnership with Karyopharm and obtained exclusive rights for development and commercialization four of Karyopharm’s clinical-stage, novel, oral drug candidates, including Selinexor, in various Asian countries and regions. In consideration of differences in treatment landscape between China and the U.S., Antengene plans to first pursue an indication of Selinexor in treatment of relapsed/refractory multiple myeloma patients whose disease progressed after treatment with chemotherapy, proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs). Antengene Corporation has communicated clinical development and filing plans in relapsed/refractory multiple myeloma and following indications with health authority in China.
Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,400 patients have been treated with selinexor. In April 2018, Karyopharm reported positive top-line data from the Phase 2b STORM study evaluating selinexor in combination with low-dose dexamethasone in patients with penta-refractory multiple myeloma. Selinexor has been granted Orphan Drug Designation in multiple myeloma and Fast Track designation for the patient population evaluated in the STORM study. Karyopharm plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) during the second half of 2018, with a request for accelerated approval for oral selinexor as a new treatment for patients with penta-refractory multiple myeloma. The Company also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2019 with a request for conditional approval. Selinexor is also being evaluated in several other mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade® (bortezomib) and low-dose dexamethasone (BOSTON) and as a potential backbone therapy in combination with approved therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), liposarcoma (SEAL), and an investigator-sponsored study in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform Karyopharm's clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.
About Karyopharm Therapeutics
Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport and related targets for the treatment of cancer and other major diseases. Karyopharm's SINE compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm’s lead compound, XPOVIOTM (selinexor), received accelerated approval from the FDA on 3rd July 2019 in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma (RRMM). A Marketing Authorization Application for selinexor is also currently under review by the European Medicines Agency (EMA). In addition to single-agent and combination activity against a variety of human cancers, SINE compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm currently has several investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com.
Antengene Corporation is a biopharmaceutical company focused on drug discovery, clinical development and the commercialization of innovative therapeutics to meet unmet medical needs. Antengene aims to provide the most advanced and first-in-class anti-cancer drug treatments for patients around the world. On April 13, 2017, Celgene Corporation (NASDAQ: CELG), a global leading innovative biopharmaceutical company became a long-term strategic partner and obtained an equity position in Antengene. Antengene's pipeline includes six commercial and clinical stage products: ATG-010 (selinexor), in combination with the corticosteroid dexamethasone, has been approved by the U.S. Food and Drug Administration, for the treatment of adult patients with relapsed or refractory multiple myeloma. The compound is also in late clinical development for various other hematologic malignancies and solid tumors. ATG-008, a second-generation dual mTORC1/2 inhibitor, is in a multi-regional clinical trial for treatment of hepatocellular carcinoma and multiple other solid tumors. Two other Phase 1 and Phase 2 clinical stage drugs, ATG-016 and ATG-019, are being studied in multiple cancer types, including MDS, colorectal and prostate cancers. ATG-527 is being explored for multiple anti-viral indications, including respiratory syncytial virus (RSV), and Epstein-Barr virus (EBV) related diseases, etc. ATG-017 is a potent and selective small molecule extracellular signal–regulated kinases 1 and 2 (ERK1/2) inhibitor, in clinical development for multiple solid tumors. Antengene drug discovery team focuses on development of first-in-class novel products.