Trubion Announces Presentation of Positive TRU-016 Data at ASCOTRU-016 Produces Significant Anti-Tumor Activity and Long-Term Tumor Regression in Pre-Clinical Studies
SEATTLE, June 02, 2008 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals Inc. today announced presentation of positive pre-clinical data showing that Trubion's TRU-016 has potent anti-tumor activity and induces significant long-term tumor eradication in a human tumor xenograft model in which rituximab failed to induce durable responses. TRU-016 is Trubion's proprietary CD37-targeted therapy in development for B-cell malignancies such as chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL).
ASCO Abstract 3074
TRU-016, a small modular immunopharmaceutical (SMIPTM) candidate, targets the CD37 antigen on human B cells. Data from both in vivo and in vitro studies presented at the American Society of Clinical Oncology (ASCO) 2008 Annual Meeting showed TRU-016 has potent anti-tumor activity and induces significant long-term tumor eradication in a human tumor xenograft model in which rituximab failed to induce durable responses. Moreover, TRU-016 treatment produced anti-tumor activity that resulted in increased survival and a significant delay in tumor growth in NHL xenografts.
"Data from this study, combined with data from previous studies, reinforce our belief that TRU-016's novel mechanism of action may provide patients with a potent new therapeutic option for the treatment of B-cell malignancies," said Peter Thompson, M.D., FACP, president, chief executive officer and chairman of Trubion. "TRU-016 represents a first-in-class product opportunity with an exciting, differentiated pre-clinical profile. The demonstrated ability of TRU-016 to kill tumor cells through powerful apoptotic signaling as well as potent ADCC-mediated activity, combined with its synergy with chemotherapies and anti-CD20 therapies, adds to our confidence that this drug, either alone or in combination with other effective therapies, may offer meaningful benefits to patients with these diseases. We look forward to the results of our ongoing Phase 1/2 clinical trial currently evaluating TRU-016 in CLL patients."
Trubion is a biopharmaceutical company that is creating a pipeline of novel protein therapeutic product candidates to treat autoimmune and inflammatory diseases and cancer. The company's mission is to develop a variety of first-in-class and best-in-class product candidates, customized for optimal safety, efficacy, and convenience that it believes may offer improved patient experiences. Trubion's current product candidates are novel single- chain protein, or SMIP(TM), therapeutics, and are designed using its custom drug assembly technology. Trubion's product pipeline includes CD20-directed candidates such as TRU-015 and SBI-087 for autoimmune and inflammatory diseases, developed under the company's Wyeth collaboration. Trubion's product pipeline also includes Trubion's proprietary product candidate, TRU-016, a novel CD37-targeted therapy for the treatment of B-cell malignancies that is currently in Phase 1/2 clinical evaluation. In addition to Trubion's current product candidates, the company is also developing additional alliance and proprietary product candidates that build on its product development experience. More information is available in the investors section of Trubion's website: investors.trubion.com.
Certain statements in this release may constitute "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934 and Section 27A of the Securities Act of 1933. These statements include, but are not limited to, those related to the company's future clinical development programs and the timing thereof, the company's future regulatory filings and the timing and outcome thereof and the company's expected financial and operating results. These statements are based on current expectations and assumptions regarding future events and business performance and involve certain risks and uncertainties that could cause actual results to differ materially. These risks include, but are not limited to, risks associated with the company's Wyeth collaboration, including Wyeth's control over development timelines, the risks that the Company is unable to advance its clinical development programs and regulatory applications and action at the rate it expects, including the risk that the Company's Phase 1/2 clinical evaluation of TRU-016 may not be successful, the risk that the Company does not achieve the financial and operating results it expects, and such other risks as identified in the company's quarterly report on Form 10-Q for the period ended March 31, 2008, and from time to time in other reports filed by Trubion with the U.S. Securities and Exchange Commission. Trubion undertakes no duty to update any forward-looking statement to conform the statement to actual results or changes in the company's expectations.
Posted: June 2008