Exhibit 99.1
Unum Therapeutics Presents Preliminary Results from Ongoing Phase 1 StudyATTCK-17-01 at the 2018 ASH Annual Meeting
CAMBRIDGE, MA, December 1, 2018 – Unum Therapeutics Inc. (NASDAQ: UMRX), today announced preliminary results from the ongoing Phase 1ATTCK-17-01 study, testing ACTR087 in combination withSEA-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 agentSEA-BCMA, and of ACTR087 in combination withSEA-BCMA, in theATTCK-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 ofSEA-BCMA with ACTR087. These data support continued dose escalation of ACTR087 andSEA-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 ofSEA-BCMA,” said Michael Vasconcelles, Chief Medical Officer of Unum. “Combining ACTR087 with a novel antibody likeSEA-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 inATTCK-17-01 to further assess its safety and anti-myeloma activity.”
The majority of subjects, including at the lowestSEA-BCMA dose levels, demonstrated increasing serum and urine M protein levels duringSEA-BCMA single-agent dosing that stabilized or decreased following ACTR087 administration, suggesting combination activity ofACTR087+SEA-BCMA. Subjects exhibited early increases in interferon gamma following ACTR087 administration, and additional elevations following subsequentSEA-BCMA administrations, suggestive of antibody-dependent T cell activation.SEA-BCMA was well-tolerated with no serious adverse events related toSEA-BCMA reported. No DLTs after theSEA-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 theATTCK-17-01 Trial
ACTR087 used in combination withSEA-BCMA is being tested inATTCK-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 withSEA-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 andSEA-BCMA pharmacokinetics. Immediately following leukapheresis, patients may begin to receiveSEA-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 withSEA-BCMA
ACTR087 is a4-1BB-containing receptor that also has been evaluated in combination with rituximab in adult patients with relapsed or refractorynon-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.