SEATTLE, Nov. 11 Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN) announced today the acceptance of two data presentations on its product candidate, TRU-016, at the 2009 American Society of Hematology (ASH) Annual Meeting Dec. 5-8, 2009 in New Orleans, Louisiana. The presentations will include additional positive data from 1) an ongoing Phase 1 clinical trial of TRU-016 for the treatment of chronic lymphocytic leukemia (CLL), and 2) a preclinical study demonstrating the effect of Trubion's Tru-ADhanCe(TM) technology in promoting enhanced natural killer cell mediated cytotoxicity against primary CLL cells. TRU-016 is Trubion's novel CD37-targeted therapy for the treatment of B-cell malignancies and is being developed in collaboration with Facet Biotech Corporation.
Presentation 3424: A Phase 1 Trial of TRU-016, An Anti-CD37 Small Modular Immunopharmaceutical (SMIP(TM)) Protein in Relapsed and Refractory CLL: Early Promising Clinical Activity
Conclusions: To date, TRU-016 is a well-tolerated treatment with minimal infusional toxicity and the maximum tolerated dose (MTD) has not been reached. One partial response (PR) and a median reduction of 83% in peripheral lymphocytosis have been observed. Encouraging reduction in lymph node/spleen size and improvement in normal hematopoietic function in patients with high-risk genomic CLL have been observed at low doses of CD37. The protocol has been amended to explore higher saturating doses of CD37. Future single-agent and combination studies of TRU-016 in CLL are warranted.
Presentation 1744: Glycovariant CD37 Small Modular Immunopharmaceutical (Tru-ADhanCe(TM) SMIP) Promotes Enhanced Natural Killer Cell Mediated Cytotoxicity against Primary CLL Cells
Conclusions: Results of this study suggest that Tru-ADhanCe(TM) technology promotes enhanced natural killer cell mediated cytotoxicity against primary CLL cells and the potential use of Tru-ADhanCe versions of TRU-016 with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) function as an alternate for TRU-016 in B cell malignancies, including CLL therapy.
Copies of the TRU-016 abstracts are now available on ASH's website at http://www.hematology.org or Trubion's website at http://investors.trubion.com/events.cfm. Copies of the full data presentations will be available on Trubion's website after the data is presented at the 2009 ASH Annual Meeting.
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, therapeutics, and are designed using its custom drug assembly technology. Trubion's product pipeline includes CD20-directed SMIP therapeutics such as TRU-015 and SBI-087 for autoimmune and inflammatory diseases, developed under the Company's Pfizer collaboration. Trubion's product pipeline also includes TRU-016, a novel CD37-targeted therapy for the treatment of B-cell malignancies developed under the company's Facet collaboration. In addition to Trubion's current clinical stage product pipeline, the Company is also developing its multi-specific SCORPION technology, both for targeting cell-surface molecules like CD79b and HLA-DR, as well simultaneously neutralizing soluble ligands like TNF and IL-6. More information is available in the investors section of Trubion's website: http://investors.trubion.com/index.cfm.
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 potential development and commercialization of TRU-016. 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 ability to develop TRU-016 with Facet and such other risks as are identified in the Company's quarterly report on Form 10-Q for the period ended Sept. 30, 2009, and from time to time in other reports filed by Trubion with the U.S. Securities and Exchange Commission. These reports are available on the Investors page of the company's corporate website at http://www.trubion.com. Trubion undertakes no duty to update any forward-looking statement to conform the statement to actual results or changes in the Company's expectations.
Monday, Dec. 7, 2009, 6:00 PM-8:00 PM Hall E (Ernest N. Morial Convention Center) Poster Board III-361
SOURCE Trubion Pharmaceuticals, Inc.