RALEIGH, N.C. and SHANGHAI, June 12, 2019 (GLOBE NEWSWIRE) — Xynomic Pharmaceuticals Holdings, Inc. (“Xynomic”, Nasdaq: XYN), a clinical stage US-China oncology drug development company, announced that it recently held a pre-IND meeting with the U.S. Food and Drug Administration (FDA) for its pan-PAF inhibitor XP-102 (BI 882370) for the treatment of cancers. The FDA addressed Xynomic’ questions related to CMC, nonclinical and clinical protocol, and provided valuable advice on overall clinical development plan to advance this drug candidate. Xynomic is on track to file this Investigational New Drug (“IND”) application in the second half of 2019.
XP-102 is a second generation potent and selective pan-RAF inhibitor uniquely binding to the DFG-out conformation, whereas marketed BRAF inhibitors occupy the DFG-in conformation. In the colorectal cancer (CRC) animal models, XP-102 showed superior anti-tumor activity to vemurafenib, a marketed BRAF inhibitor in both the Colo-205V600V/E model and HT-29V600V/E model. XP-102 in combination with cetuximab induced tumor regressions in the less sensitive HT-29 model.
“Our meeting with the FDA was a major step forward and the feedbacks provided by the agency was valuable in our development of clinical and regulatory strategies that will support our goal of advancing XP-102 through clinical development,” said Y. Mark Xu, Xynomic’ Chairman and CEO. “We believe that XP-102 holds potential as an innovative therapy against B-RAF V600 mutated solid tumors including CRC and non-small cell lung cancer and hairy cell leukemia.”
About Xynomic Pharmaceuticals Holdings, Inc. Xynomic Pharmaceuticals Holdings, Inc. is a clinical stage oncology-focused biopharmaceutical company. Its current pipeline mainly consists of three drug candidates, abexinostat, XP-105 and XP-102; 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 against 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 against solid tumors. Xynomic’s pre-clinical oncology drug candidate XP-102 (BI 882370) is a pan-RAF inhibitor.
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