ArQule Announces Data Presentations with ARQ 087, Inhibitor of FGFR, at AACR

Key findings provide correlation between biomarkers and clinical responses

AACR Annual Meeting 2015

WOBURN, Mass.--()--ArQule, Inc. (Nasdaq:ARQL) today announced that data with ARQ 087, a potent FGFR (Fibroblast Growth Factor Receptor) inhibitor, will be presented today at the 2015 Annual Meeting of the American Association for Cancer Research (AACR). ARQ 087 is currently in a Phase 2 trial in patients with Intrahepatic Cholangiocarcinoma (iCCA) with FGFR2 fusions and a Phase 1b trial in adrenocortical tumors and tumors with FGFR translocations, amplification and mutations.

“Important data with ARQ 087 presented at AACR demonstrate the correlation of circulating FGF levels with clinical benefit in patients, including tumor responses seen to date in iCCA following single agent treatment with this compound,” said Brian Schwartz, M.D., chief medical officer of ArQule. “These findings provide additional rationale for the ongoing clinical development of this compound as a highly targeted therapeutic option in advanced solid tumors. Additional data from another presentation underscore the potential broad therapeutic application of ARQ 087, in combination with other anti-cancer agents.”

ARQ 087 Presentations

Abstract Number CT319
Presentation Title: Determination of FGF 19, 21 and 23 protein levels in a phase 1 clinical trial of ARQ 087, an oral pan-FGFR inhibitor
Presentation Time: Tuesday, April 21, 2015, 8:00 AM – 12:00 PM
Location: Section 24

Abstract Number 3500
Presentation Title: Combinations of ARQ087 with chemotherapeutic agents are safe and show a striking antitumor activity in different xenograft models (abstract # 3500; sec 27, board # 23)
Presentation Time: Tuesday, April 21, 2015, 8:00 AM – 12:00 PM
Location: Section 27

About ArQule

ArQule is a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics. The Company’s targeted, broad-spectrum products and research programs are focused on key biological processes that are central to human cancers. ArQule’s lead product, in Phase 2 and Phase 3 clinical development, is tivantinib (ARQ 197), an oral, selective inhibitor of the c-MET receptor tyrosine kinase. The Company’s pipeline includes: ARQ 092, designed to inhibit the AKT serine/threonine kinase; ARQ 087, a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor (FGFR) family; and ARQ 761, a Beta lapachone analog being evaluated as a promoter of NQ01-mediated programmed cancer cell necrosis. ArQule’s current discovery efforts are focused on the identification of novel kinase inhibitors, leveraging the Company’s proprietary library of compounds.

This press release contains forward-looking statements regarding the Company’s clinical trials and planned clinical trials with ARQ 087, as well as its ability to fund operations with current cash and marketable securities. These statements are based on the Company’s current beliefs and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially. Positive information about pre-clinical and early stage clinical trial results does not ensure that later stage or larger scale clinical trials will be successful. For example, ARQ 087 may not demonstrate promising therapeutic effect; in addition, it may not demonstrate appropriate safety profiles in current or later stage or larger scale clinical trials as a result of known or as yet unanticipated side effects. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards or to justify further development. Problems or delays may arise prior to the initiation of planned clinical trials, during clinical trials or in the course of developing, testing or manufacturing ARQ 087 that could lead the Company to fail to initiate or to discontinue development. Even if later stage clinical trials are successful, unexpected concerns may arise from subsequent analysis of data or from additional data. Obstacles may arise or issues may be identified in connection with review of clinical data with regulatory authorities. Regulatory authorities may disagree with the Company’s view of the data or require additional data or information or additional studies. In addition, the planned timing of initiation and completion of clinical trials for ARQ 087 is subject to the ability of the Company to enroll patients, enter into agreements with clinical trial sites and investigators, and overcome technical hurdles and other issues related to the conduct of the trials. There is a risk that these issues may not be successfully resolved. In addition, we expect to utilize diagnostic tools in our biomarker-guided clinical trials with ARQ 087; we may encounter difficulties in developing and obtaining approval for companion diagnostics, including issues relating to selectivity/specificity, analytical validation, reproducibility, or clinical validation. Any delay or failure by our collaborators or ourselves to develop or obtain regulatory approval of the companion diagnostics could delay or prevent approval of our product candidates. Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Positive pre-clinical data may not be supported in later stages of development. Furthermore, ArQule may not have the financial or human resources to successfully pursue drug discovery in the future. For more detailed information on the risks and uncertainties associated with the Company’s drug development and other activities, see the Company’s periodic reports filed with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update any forward-looking statements.

Contacts

ArQule, Inc.
William B. Boni, 781-994-0300
VP, Investor Relations/Corp. Communications
www.ArQule.com

Release Summary

ArQule announces data presentations with ARQ 087, FGFR inhibitor, at AACR 2015.

Contacts

ArQule, Inc.
William B. Boni, 781-994-0300
VP, Investor Relations/Corp. Communications
www.ArQule.com