Xynomic Pharma Receives Fast-Track Designation from the US FDA for Abexinostat as 4L Therapy Treating Follicular Lymphoma
SHANGHAI, Sept. 23, 2019 (GLOBE NEWSWIRE) — Xynomic Pharmaceuticals Holdings, Inc. (“Xynomic”, stock ticker: XYNO), a clinical stage US-China oncology drug development company, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast-Track designation to Xynomic’s lead drug candidate abexinostat, for use as a single agent, as a fourth-line treatment of relapsed or refractory follicular lymphoma (“FL”). Fast-Track is a designation by the FDA to facilitate the development and expedite the review of drugs to treat serious or life-threatening conditions and fill an unmet medical need.
According to the U.S. National Cancer Institute, FL is the most common indolent non-Hodgkin’s lymphoma subtype in the U.S. with approximately 14,840 new cases per year. It often requires multiple lines of treatment. Despite current available therapies, the outlook for patients that fail third line FL treatment remains poor. The median PFS and EFS were both less than 1 year after third line of treatment. Xynomic is conducting a potentially pivotal Phase 2 trial of abexinostat, for use as a single agent, as a fourth-line treatment of relapsed or refractory FL in the U.S. and Europe.
FDA has already granted Fast-Track designation to abexinostat, in combination with pazopanib, as a first- or second-line treatment of renal cell carcinoma.
About Xynomic Pharmaceuticals Holdings, Inc.
Xynomic Pharmaceuticals Holdings, Inc. is a clinical stage oncology-focused biopharmaceutical company. Its current pipeline mainly consists of 3 drug candidates; Xynomic owns global exclusive development, manufacturing and commercialization rights to each of these. Its lead drug candidate, abexinostat, is in global potentially pivotal clinical trials for the treatment of renal cell carcinoma (in combination with pazopanib) and non-Hodgkin’s lymphoma (as a single agent). Xynomic’s other clinical stage drug candidate XP-105 (BI 860585) is a Phase 2 ready, ATP-competitive mTORC1/2 inhibitor for the treatment of solid tumors. Xynomic’s pre-clinical oncology drug candidate XP-102 (BI 882370) is a pan-RAF inhibitor.
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