ACTR-707

CAMBRIDGE, Mass., Dec. 01, 2018 (GLOBE NEWSWIRE) -- Unum Therapeutics Inc. (NASDAQ: UMRX), today announced preliminary results from the ongoing Phase 1 ATTCK-17-01 study, testing ACTR087 in combination with SEA-BCMA in patients with relapsed/refractory multiple myeloma (r/r MM) at the American Society of Hematology (ASH) meeting in San Diego, CA. First-in-human dosing of single agent SEA-BCMA, and of ACTR087 in combination with SEA-BCMA, in the ATTCK-17-01 multi-center, open-label Phase 1 dose-escalation study was well-tolerated, with no dose-limiting toxicities (DLTs) in the first three cohorts. Following infusion, ACTR+ T cells were detectable in these patients and demonstrated expansion post infusion. Furthermore, early disease assessments suggest combination activity of SEA-BCMA with ACTR087. These data support continued dose escalation of ACTR087 and SEA-BCMA in the trial. “We are pleased with the early data we have observed showing biomarker evidence of antibody-dependent ACTR T cell activation at the lowest doses of SEA-BCMA,” said Michael Vasconcelles, Chief Medical Officer of Unum. “Combining ACTR087 with a novel antibody like SEA-BCMA brings together multiple anti-myeloma mechanisms of action that are unique to this combination. Furthermore, this approach provides us the ability to adjust the doses of both the antibody and ACTR087, to optimize the therapeutic index of the combination. We are excited about the potential to develop a meaningful combination for patients with relapsed or refractory myeloma. We look forward to continued dose escalation of the combination in ATTCK-17-01 to further assess its safety and anti-myeloma activity.” The majority of subjects, including at the lowest SEA-BCMA dose levels, demonstrated increasing serum and urine M protein levels during SEA-BCMA single-agent dosing that stabilized or decreased following ACTR087 administration, suggesting combination activity of ACTR087+SEA-BCMA. Subjects exhibited early increases in interferon gamma following ACTR087 administration, and additional elevations following subsequent SEA-BCMA administrations, suggestive of antibody-dependent T cell activation. SEA-BCMA was well-tolerated with no serious adverse events related to SEA-BCMA reported. No DLTs after the SEA-BCMA single-agent dosing period or after the ACTR087 + SEA-BCMA combination were reported across all three cohorts. No severe events of cytokine release syndrome (CRS) or severe neurological events were reported. About the ATTCK-17-01 Trial ACTR087 used in combination with SEA-BCMA is being tested in ATTCK-17-01, a Phase I, multi-center, open-label clinical trial designed to test the safety, tolerability, and anti-myeloma activity in patients with r/r MM, currently in the dose escalation phase. Primary study objectives are to characterize the safety of ACTR087 in combination with SEA-BCMA and to determine the recommended Phase 2 dose. Secondary study objectives include assessment of the anti-myeloma activity of the combination, ACTR T cell expansion and persistence, cytokine and SEA-BCMA pharmacokinetics. Immediately following leukapheresis, patients may begin to receive SEA-BCMA as a single agent. Following lymphodepleting chemotherapy, a single ACTR087 infusion is administered. This is the first clinical trial conducted under the Company’s strategic collaboration with Seattle Genetics. About ACTR087 in combination with SEA-BCMA ACTR087 is a 4-1BB-containing receptor that also has been evaluated in combination with rituximab in adult patients with relapsed or refractory non-Hodgkin lymphoma (r/r NHL). SEA-BCMA is a novel humanized non-fucosylated antibody that targets the antigen BCMA, developed by Seattle Genetics using the Company’s sugar-engineered antibody (SEA) technology. BCMA is expressed on normal plasma cells, some mature B cells, and at comparatively elevated levels on malignant multiple myeloma cells but is absent from other normal tissues. SEA-BCMA is engineered to enhance its binding to ACTR087, providing additional rationale for this novel-novel combination. 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. Unum has three product candidates currently in Phase I clinical testing, including: ACTR707 used in combination with rituximab, an anti-CD20 antibody, in adult patients with relapsed or refractory non-Hodgkin lymphoma (r/r NHL); ACTR087 used in combination with the novel antibody SEA-BCMA in adult patients with relapsed or refractory multiple myeloma; and ACTR707 used in combination with trastuzumab, an anti-human epidermal growth factor receptor 2 (HER2) antibody, in adult patients with HER2+ advanced cancer. 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 design of our clinical trials, including ATTCK-17-01, the anticipated timing and outcomes of our clinical trials, the development of our product candidates, including the three lead ACTR product candidates, the results of our clinical trials, including ATTCK-17-01, 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. Investor Contact: Stephanie Ascher, 212-362-1200 stephanie@sternir.com Media Contact: Paul Kidwell, 617-680-1088 paul.kidwell@unumrx.com NEXT ARTICLE More From BioPortfolio on "Unum Therapeutics Presents Preliminary Results from Ongoing Phase 1 Study ATTCK-17-01 at the 2018 ASH Annual Meeting" Related Companies Related Clinical Trials Related PubMed Entries Related Medications

IPO letter in the billboard screen jxfzsy/Getty Images/iStockphoto In an initial public offering, Unum Therapeutics snagged nearly $70 million to fund its antibody-coupled T-cell receptor technology. In an initial public offering, Unum Therapeutics snagged nearly $70 million to fund its antibody-coupled T-cell receptor technology. Shares of Unum will begin selling on the Nasdaq Exchange this morning under the ticker symbol UMRX. On Wednesday the company said it sold 5.77 million shares at $12 each to garner $69.2 million. Cambridge, Mass.-based Unum announced its intent to IPO at the beginning of March. The company said it intended to seek an initial pricing of its stock at $12 to $14. From its announcement last night, the company came in on the low end of its initial plan. When Unum initially announced its IPO earlier this month the announcement was overshadowed by some concerning data regarding its Phase I non-Hodgkin lymphoma therapy that included toxicity concerns at higher dosing levels. In a filing with the U.S. Securities and Exchange Commission Unum said two of the nine patients who received the higher dose died from serious adverse events. Additionally, Unum said an additional patient died following an ACTR087-related severe CRS (cytokine release syndrome). In its IPO announcement, the company noted that the trial had been placed on clinical hold by the U.S. Food and Drug Administration due to the concerns. However, by the time the company publicly disclosed the issues with its trial, the FDA had already released the trial from clinical hold. That lack of disclosure may be concerning to some investors who intend to buy shares of the now public company. Unum is combining its lead product ACTR087 with Genentech ’s Rituxan (rituximab) as a treatment for adult patients with relapsed or refractory non-Hodgkin lymphoma. In the filing with the SEC, the company noted it saw positive data in a small cohort of patients at a lower dose. Unum’s ACTR technology is part of the ever-growing immuno-oncology field. Its ACTR product candidates take T cells from patients and then genetically modify them to express the ACTR protein. ACTR is a chimeric protein which combines parts of proteins found on both T cells and natural killer cells to create a doubly-powerful attack on cancer cells. Those modified cells are then re-administered to the patient with a tumor-specific antibody. In its SEC filing the company said when an ACTR T cell encounters a tumor cell bound with antibodies, the modified product will bind to the antibodies and kills the tumor cell through a process known as antibody-dependent cellular cytotoxicity (ADCC). That is a function not normally observed with T cells, Unum said in its filing. While Unum is developing its own programs, including a Phase I program for ACTR707, a modified ACTR construct, the company has a collaborative deal with Seattle Genetics . The two companies first forged an agreement in 2015 and now have moved into the clinic. Unum’s ACTR087 in combination with Seattle Genetics novel antibody SEA-BCMA is being studied in adult patients with relapsed or refractory multiple myeloma.