Globe Newswire 9-Nov-2018 2:31 PM
Initiating Phase 1 ATTCK-34-01 Trial in HER2+ Advanced Cancers by Year-End
CAMBRIDGE, Mass., Nov. 09, 2018 (GLOBE NEWSWIRE) -- Unum Therapeutics Inc. (NASDAQ:UMRX), a clinical-stage biopharmaceutical company focused on the development of novel cellular immunotherapies, today announced that the Company will present preclinical data on the potential of its proprietary ACTR technology in HER2+ solid tumors and details on the design of its planned Phase 1 clinical trial to test ACTR707 in combination with trastuzumab at the upcoming San Antonio Breast Cancer Symposium taking place December 4-8, 2018 in San Antonio, Texas.
In preclinical testing, Unum has demonstrated robust activity of its proprietary ACTR T cells in combination with trastuzumab. Importantly, preclinical data demonstrate that, unlike certain CAR-T cells that target HER2, ACTR T cells are highly selective for HER2-overexpressing tumor cells and discriminate against cells from normal tissues that express low levels of HER2. Additionally, the activity of ACTR T cell has been shown to be dose-dependent, demonstrating control of ACTR activity by modulation of trastuzumab concentration. Together these data suggest that ACTR cells in combination with trastuzumab may exhibit an improved clinical therapeutic index.
"We are encouraged by these preclinical data, which further highlight our novel ACTR technology pipeline and demonstrate our innovative approach to overcoming current challenges in the solid tumor setting," said Seth Ettenberg, Chief Scientific Officer of Unum.
"We have an active IND to evaluate ACTR707 in combination with trastuzumab as a potential treatment for HER2+ solid tumor cancers in a Phase I trial called ATTCK-34-01, and we remain on track to initiate this study before the end of 2018," said Michael Vasconcelles, Chief Medical Officer of Unum. "We look forward to continuing our work in the solid tumor setting and reporting initial data in 2019."
ATTCK-34-01 is a multicenter, single-arm, open-label dose escalation study evaluating ACTR T cells in combination with trastuzumab. The primary study objectives are to assess the safety and tolerability of the combination, and to define dose recommendations for further study. Additional objectives include assessment of anti-tumor activity, ACTR T cell persistence and trastuzumab pharmacokinetics.
Details on the presentation are as follows:
Presentation Title: Antibody-Coupled T cell Receptor (ACTR) engineered autologous T cells in combination with trastuzumab for the treatment of HER2-positive malignancies
Session Title: HER2-Targeted Therapy
Date & Time: Thursday, 12/6/18; 5 – 7 PM
Location: Henry G. Gonzalez Convention Center
About Unum Therapeutics
Unum Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products designed to harness the power of a patient's immune system to cure cancer. Unum's novel proprietary technologies include Antibody-Coupled T cell Receptor (ACTR), a universal, engineered cell therapy intended to be used in combination with a wide range of tumor-specific antibodies to target different tumor types, and Bolt-On Chimeric Receptor (BOXR), an approach for improving T cell functionality to enable solid tumor cancer applications. ACTR087 and ACTR707, each used in combination with rituximab, an anti-CD20 antibody, are Unum's two most advanced product candidates, currently in Phase I clinical testing in adult patients with relapsed or refractory non-Hodgkin lymphoma (r/r NHL). The Company has an additional product candidate in Phase I clinical testing: ACTR087 used in combination with the novel antibody SEA-BCMA in adult patients with relapsed or refractory multiple myeloma. Finally, the Company has an active investigational new drug application (IND) for ACTR707 used in combination with trastuzumab, an anti-human epidermal growth factor receptor 2 (HER2) antibody, to treat patients with HER2+ advanced cancer. This Phase I trial is expected to be initiated by the end of 2018.
The Company is headquartered in Cambridge, MA.
Forward looking Statements
This press release contains forward-looking statements. Statements in this press release about our future expectations, plans and prospects, our long-term growth and our ability to achieve our strategy, the anticipated timing of our clinical trials and regulatory filings, the development of our product candidates, including the four lead ACTR product candidates, the results of our clinical trials, as well as other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the forecasts disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results could differ materially from the projections disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to the accuracy of our estimates regarding expenses, future revenues, capital requirements, and the need for additional financing, the success, cost and timing of our product development activities and clinical trials, our ability to obtain and maintain regulatory approval for our product candidates, and the other risks and uncertainties described in the "Risk Factors" sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.
Stephanie Ascher, 212-362-1200
Paul Kidwell, 617-680-1088
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