Why it is profiled?The company will be making four presentations at the ASCO Annual Meeting next month
ArQule Inc. (ARQL) is a clinical-stage biotechnology company pursuing innovative approaches to cancer therapy. The shares have doubled in value from their 52-week low of $2.97 set in February and trade around $6.
The company's lead product candidate is ARQ 197, a non-adenosine triphosphate, which is a competitive inhibitor of c-Met receptor tyrosine kinase, a promising target for cancer therapy. ARQ 197 is being evaluated as a single agent and in combination with other targeted therapies and cytotoxic agents.
ARQ 197 is under phase II development for six tumor types, including non-small cell lung cancer, c-Met-associated soft tissue sarcomas, pancreatic adenocarcinoma, hepatocellular carcinoma, germ cell tumors and colorectal cancer.
Under an agreement signed in 2008, Arqule licensed commercial rights to ARQ 197 for human cancer indications to Daiichi Sankyo Co., Ltd. in the U.S., Europe, South America and the rest of the world, excluding Japan and certain other Asian countries, where it has been licensed to Kyowa Hakko Kirin Co., Ltd. The costs of phase II and phase III clinical studies of ARQ 197 will be shared equally by ArQule and Daiichi.
ArQule's share of phase III costs are payable solely from milestone and royalty payments by Daiichi Sankyo. So far, the expenses incurred by ArQule to third parties for pre-clinical and clinical trials of the ARQ 197 program amount to nearly $57 million.
ArQule is also pursuing a drug discovery collaboration with Daiichi Sankyo that utilizes the capabilities of ArQule's kinase inhibitor discovery platform to discover compounds in the field of oncology.
In March of this year, the company announced promising results from a mid-stage trial of ARQ 197 in patients with advanced non-small cell lung cancer. According to the trial results, patients when treated with a combination of ARQ 197 and cancer drug Tarceva , had a median PFS (progression-free survival) of 16.1 weeks, while patients treated with Tarceva plus placebo had a median progression-free survival of 9.7 weeks. Thus, ARQ 197 demonstrated a 66% improvement in progression-free survival in patients with advanced non-small cell lung cancer.
In patients with non-squamous tumors, who were treated with a combination of ARQ 197 and Tarceva, median PFS was 18.9 weeks compared to 9.7 weeks in the control arm, which represented a 94% improvement.
According to the company, the findings from this phase II trial have been chosen for oral presentation at the ASCO meeting next month, and completed data from the trial are expected to be presented.
Additionally, the company will be making three poster presentations.
The three poster presentations include
- The final results from a phase Ib safety trial evaluating ARQ 197 in cirrhotic patients with hepatocellular carcinoma. At the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in January, 2010, the company had presented data from the phase 1 single agent safety trial in hepatocellular carcinoma, and ARQ 197 was shown to be well tolerated in the patient population, and no drug related worsening of liver function was observed.
- A phase I dose-escalation trial evaluating ARQ 197 administered in combination with sorafenib in adult patients with advanced solid tumors. The first patient in the phase 1 ARQ 197-sorafenib combination therapy safety trial was dosed last June and
- A randomized, placebo-controlled phase II clinical trial evaluating ARQ 197 in patients with hepatocellular carcinoma. The company initiated enrollment in the phase II monotherapy trial with ARQ 197 in hepatocellular carcinoma last September.
ArQule's other investigational cancer drugs include - ARQ 621, an inhibitor of the Eg5 kinesin motor protein, which is under phase I development, BRAF kinase inhibitor and FGFR program that are under preclinical development.
Looking ahead to 2010, ArQule is planning
- To analyze and announce results of the phase II trial of ARQ 197 in a sub-group of soft tissue sarcoma in the second half of this year.
- To complete patient accrual in the phase 1 combination therapy trial in gemcitabine-treated tumors.
- Accrual of patients in the recently initiated phase II trials in colorectal cancer and germ cell tumors.
- File at least one Investigational New Drug application for B-RAF kinase or FGFR kinase program, which has therapeutic potential in cancer.
From inception through March 31, 2010, ArQule has incurred a cumulative deficit of $378.3 million. The company's revenue consists primarily of development funding from its alliances with Daiichi Sankyo and Kyowa Hakko Kirin.
At March 31, 2010, the company had a total of $146.76 million in cash, equivalents and marketable securities, which include $39.8 million drawn down during 2008 under notes payable that are collateralized by its auction rate securities. The net use of cash this year is expected to range between $43 million and $47 million. ArQule expects to end 2010 with $70 million-$74 million in cash and marketable securities.
ASCO Run-up Plays
Celldex Therapeutics
ImmunoGen Inc.
Other stocks "in the spotlight"
For comments and feedback contact: editorial@rttnews.com
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.