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-Complete Responses Observed in Three of Six Patients with relapsed or refractory CD20-positive B cell non-Hodgkin Lymphoma at Dose Level 1 of the ATTCK-20-03 Phase I Study -
- No SAEs of Cytokine Release Syndrome or Neurotoxicity Observed in Dose Level 1 -
- Study Enrollment Continues -
-Management to host conference call today at 8:30 a.m. EDT-
CAMBRIDGE, Mass., Sept. 17, 2018 (GLOBE NEWSWIRE) -- Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies based on its novel, universal Antibody-Coupled T cell Receptor (ACTR) technology platform, today announced that the Company will be presenting data on the first dose level (40x106 ACTR+ T cells) of its ATTCK-20-03 clinical trial evaluating ACTR707 in combination with rituximab in patients with relapsed or refractory CD20-positive B cell non-Hodgkin Lymphoma (r/r NHL). Three of the six patients treated at the first dose level achieved a complete response, two of which remained ongoing at the time of the most recent data cut off. No dose-limiting toxicities (DLTs) were observed in any of the four DLT-evaluable patients, and no serious or severe adverse events of cytokine release syndrome or neurotoxicity were observed in any patients. These data will be presented at the Fourth Annual CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference on September 30 in New York, New York.
“These preliminary clinical data suggest that complete responses may be achieved without cytokine release syndrome, further validating the potential of our proprietary ACTR technology platform,” said Chuck Wilson, Chief Executive Officer of Unum. “The ATTCK-20-03 trial is a key element of our strategy to develop novel therapeutics for patients with no available treatment options.”
“Complete responses observed in this heavily pre-treated patient population at the first dose level of the ATTCK-20-03 trial support the potential potency of ACTR T cells for these patients,” said Michael Vasconcelles, Chief Medical Officer of Unum. “Based upon this encouraging preliminary profile, we look forward to continuing the dose escalation phase of this study. We expect these and future data to support selection of an ACTR product candidate to progress into potential registration trials in patients with r/r NHL.”
Enrollment and ACTR707 dosing in the second dose cohort (60x106 ACTR+ T cells) of the ATTCK-20-03 trial has been completed and dose escalation is proceeding. The Company expects to present additional data from this study later this year.
Safety and Preliminary Efficacy of ACTR707, Autologous T Lymphocytes Expressing an Antibody-Coupled T Cell Receptor, in Combination with Rituximab in Subjects with Relapsed or Refractory CD20-Positive B-cell Lymphoma (Abstract #A003)
Presenter: Dr. Veronika Bachanova, University of Minnesota
Date: Sunday, September 30, 2018, 11:45am – 2:15pm
Location: New York Marriott Marquis, Westside Ballroom
ATTCK-20-03 is a Phase I, multi-center, open label, single arm clinical trial evaluating ACTR707 in combination with rituximab in patients with r/r NHL. Eligible patients for enrollment must have, among other criteria, received adequate prior anti-lymphoma therapy, including rituximab and chemotherapy, for their CD20-positive r/r NHL. Key eligibility criteria include: pre-specified eligible NHL subtypes, including DLBCL, disease progression following immediate prior therapy, adequate organ function and performance status, and measurable disease. The trial design includes a dose escalation phase using an adaptive design, followed by a cohort expansion phase. Primary study objectives are to characterize the safety of ACTR707 in combination with rituximab and to determine the maximum tolerated dose and proposed recommended Phase 2 dose. Secondary study objectives include: assessment of the anti-lymphoma activity of the combination, ACTR707 persistence, rituximab pharmacokinetics, and inflammatory markers and cytokine levels. Following leukapheresis, each patient receives lymphodepletion followed by the first infusion of rituximab and then a single infusion of ACTR707. Rituximab infusions continue on a regular, pre-specified schedule.
Data in the first cohort of the trial demonstrate complete responses at the first response assessment in 3/6 patients treated with ACTR707 in combination with rituximab, two of which remained ongoing at the time of the most recent data cut off. There were no serious or severe adverse events of cytokine release syndrome, neurotoxicity, or autoimmune events. Grade 3 or higher adverse events were mostly hematologic including neutropenia (n=2), febrile neutropenia (n=2), and thrombocytopenia (n=1). ACTR+ T cells were detectable in all subjects and ACTR+ T cells persisted in the presence of continued rituximab administration. These results support the continued dose escalation of ACTR707 in combination with rituximab.
Conference Call and Webcast
Unum will host a conference call and webcast at 8:30 a.m. EDT today to discuss the data. To participate in the conference call, please dial (866) 300-3411 (domestic) or (636) 812-6658 (international) and enter the conference code: 2958105. To join the live webcast, please visit the investor relations section of the Unum Therapeutics website at https://investors.unumrx.com/ at least 10 minutes before the event begins. A webcast replay will be available at the same location on the Unum Therapeutics website beginning approximately two hours after the event and will be archived for 90 days.
ACTR707 is an investigational drug that may represent an important construct not only for adult patients with CD20+ r/r NHL, when used in combination with rituximab, but also for patients with other cancer types when used in combination with other antibodies. ACTR707 was identified through a comprehensive high-throughput screening effort aimed at identifying receptors with improved functional characteristics across several dimensions. In preclinical testing, ACTR707 demonstrated potent activity against a wide range of hematologic and solid tumor cancers. Given the challenges of the immunosuppressive solid tumor microenvironment, Unum believes that ACTR707’s increased activity may be particularly important in addressing solid tumor cancers. ACTR707 is currently being tested in combination with rituximab in patients with r/r NHL in a Phase I multi-center open label clinical trial, ATTCK-20-03. Testing is expected to be initiated later in 2018 in ATTCK-34-01, a Phase I multi-center open label clinical trial exploring the combination of ACTR707 with trastuzumab in patients with HER2+ advanced cancers.
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 technology, antibody-coupled T cell receptor (ACTR) is a universal, engineered cell therapy intended to be used in combination with a wide range of tumor-specific antibodies to target different tumor types. 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, the anticipated timing of our clinical trials and regulatory filings, the development of our product candidates, including the four lead ACTR product candidates, 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