July 26, 2019 12:29 ET | Source: Xynomic Pharmaceuticals Holdings, Inc.
RALEIGH, N.C. and SHANGHAI, July 26, 2019 (GLOBE NEWSWIRE) — Xynomic Pharmaceuticals Holdings, Inc. (“Xynomic”, stock ticker: XYNO), a clinical stage U.S.-China oncology drug development company, announced that it will present at the 3rd World-China Immunotherapy & Gene Therapy Congress 2019 to be held in Beijing from August 30th to August 31st. The presentation will report the interim data of the ongoing Phase 1b trial, being conducted at University of California, San Francisco, evaluating the safety and efficacy of Xynomic’s abexinostat, a pan-histone deacetylase (“HDAC”) inhibitor, in combination with Keytruda®, a humanized antibody in cancer immunotherapy, for the treatment of multiple solid tumors.
Abexinostat is a pan HDAC inhibitor that inhibits HDACs 1, 2, 3, 6, and 10. Thus, HDACs have become a therapeutic target for various types of cancers. Keytruda® is a checkpoint inhibitor (CPI), which blocks the PD-1 receptor signaling axis in patients with advanced solid tumors. Keytruda®, while effective, has significant limitations including low objective response rate (~20%) and drug resistance issues. Epigenetic modifying agents such as HDAC inhibitors have been reported to have the potential to counteract some of the mechanisms of resistance to CPI treatment. In this trial, Xynomic has already completed the dose escalation portion without any dose-limiting toxicity findings. Xynomic plans to enroll a total of approximately 42 patients in the U.S in this Phase 1b trial and expects to complete this trial by the second quarter of the fiscal year 2020.
We believe the need for cancer treatment will continue to grow, driven by the increasing awareness towards cancer prevention, early screening and diagnosis. According to a report published by Allied Market Research, the global market for cancer therapeutics was valued at $81.2 billion in 2016 and is projected to reach $178.9 billion by 2023, at a CAGR of 11.9% from 2016-2023. Specifically, the global market size for diverse types of solid tumors treated by Keytruda® is expected to reach $8.0 billion by 2023.
Furthermore, Xynomic expects to present more detailed data at the upcoming American Association for Cancer Research (AACR) annual meeting, to be held from April 24th, 2020 to April 29th, 2020, in San Diego, California.
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.
Use of Forward-Looking Statements
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Xynomic has based these forward-looking statements largely on its current expectations and projections about future events and trends that it believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions including, without limitation, risks related Xynomic’s financial position and need for additional capital to complete the planned trials and support its continuing operation, risks related to uncertainty in maintaining and obtaining regulatory approval and ultimately commercialize its drug candidates or delays in doing so; and the risks more fully described in Xynomic’s Prospectus (file No. 333-229127) and other filings that Xynomic may make with the SEC in the future. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
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