ACTR087 / Cogent Biosci - LARVOL DELTA

Antibody-coupled T cell receptor (ACTR) engineered autologous T cells in combination with trastuzumab for the treatment of HER2-positive malignancies (SABCS 2018) - P1; "ACTR087 and ACTR707 are being tested in combination with rituximab in subjects with CD20+ B cell lymphoma in two separate trials (NCT02776813 and NCT03189836, respectively). Additional objectives include assessment of anti-tumor activity, ACTR T cell persistence and trastuzumab pharmacokinetics. Enrollment is expected to commence in early 2019. "

Combination therapy • IO biomarker • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

ACTR087, Autologous T Lymphocytes Expressing Antibody Coupled T-Cell Receptors (ACTR), Induces Complete Responses in Patients with Relapsed or Refractory CD20-Positive B-Cell Lymphoma, in Combination with Rituximab (ASH 2017) - P1; "In the first dose level studied in patients with relapsed/refractory aggressive CD20+ B cell lymphoma, ACTR087 in combination with rituximab induced complete responses with no serious AEs, AEs leading to treatment discontinuation, cytokine-release syndrome, or neurotoxicity. ACTR+ T cells were detectable in all patients and ACTR+ T cells persisted in the presence of continued rituximab administration. These results support the continued dose escalation of ACTR087 in combination with rituximab; dose level 2 enrollment is ongoing and updated data, including correlative biomarkers, will be presented."

Adverse events • Combination therapy • Biosimilar • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Immunology • Venous Thromboembolism

A Phase 1 Study of Two Investigational Agents, ACTR087, an Autologous T Cell Product Expressing an Antibody-Coupled T Cell Receptor, in Combination with SEA-BCMA, a Novel Non-Fucosylated Monoclonal Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma (ASH 2018) - P1; "...ACTR087 expresses a 4-1BB-containing receptor and has been evaluated in combination with rituximab in subjects with relapsed or refractory (R/R) CD20+ B cell lymphoma as previously reported (Akard et al., Blood 2017)...After the third dose of SEA-BCMA and lymphodepleting chemotherapy (cyclophosphamide 300 mg/m2 and fludarabine 30 mg/m2, each daily for 3 days), subjects receive a single dose of ACTR087...Enrollment in Cohort 3 is ongoing. Updated data, including SEA-BCMA PK, biomarkers, and preliminary Cohort 3 data, will be presented."

Clinical • Combination therapy • P1 data • Biosimilar • Hematological Disorders • Hematological Malignancies • Immune Modulation • Inflammation • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Pain

A Phase 1 Study of ACTR087 in Combination with Rituximab, in Subjects with Relapsed or Refractory CD20-Positive B-Cell Lymphoma (ASH 2019) - P1; "Subjects received lymphodepleting chemotherapy (cyclophosphamide and fludarabine) for 3 days, followed by rituximab and a single dose of ACTR087. ACTR087+rituximab demonstrated antitumor activity, with observed safety events that are expected with other autologous T-cell products. The time to onset and clinical presentation of severe CRS and neurotoxicity events in this study informed the safety monitoring and adverse reaction management guidance across clinical studies of ACTR T-cell products. Data from this first-in-human study of ACTR087+rituximab confirm the proof of concept and will be used to guide further development for the ACTR platform."

Clinical • Combination therapy • IO biomarker • P1 data • Diffuse Large B Cell Lymphoma • Immune Modulation • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Septic Shock

At-Home Cancer Care, Infusions Widespread Amid Pandemic (Clinical Oncology News) - "Debra Patt...told Clinical Oncology News...'At our center in Austin, I would say about once a day, on average, one of our clinicians gets called over to the infusion center to manage an urgent reaction,' she said. 'They're not always life-threatening, of course. It could be that someone has developed shortness of breath or facial swelling due to a taxane, or a drop in blood pressure after rituximab. It could be altered mental status or a seizure. When that happens, we drop everything and hurry to the center to determine the appropriate course of action. That's a level of decision making that resides with the doctor; it's not within a nurse's scope of practice.'"

Media quote

Unum Therapeutics announces 2019 goals and expected milestones (GlobeNewswire) - "'We expect 2019 also to be a year of significant momentum, with data expected from all four of our ongoing clinical programs, including readouts from the ATTCK-20-03 and ATTCK-17-01 trials, as well as an initial data readout from our first study in solid tumors.'....Anticipated 2019 Milestones Complete the dose escalation phase of ATTCK-20-03, the ongoing, multicenter Phase 1 study testing ACTR707 in combination with rituximab to treat patients with relapsed/refractory B cell non-Hodgkin lymphoma; Complete enrollment in ATTCK-20-2, a Phase I clinical trial evaluating safety and anti-lymphoma activity of ACTR087 in combination with rituximab in patients with relapsed or refractory B cell NHL, and report data from the trial."

Enrollment status • P1 data • Trial status • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Unum Therapeutics presents preliminary results from ongoing phase 1 study ATTCK-17-01 at the 2018 ASH Annual Meeting (GlobeNewswire) - P1, N=30; ATTCK-17-01 (NCT03266692); Sponsor: Unum Therapeutics; "Unum Therapeutics Inc...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."

P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

UT-201501;ATTCK-20-2t: Study of ACTR087 in Subjects With Relapsed or Refractory B-cell Lymphoma (clinicaltrials.gov) - P1; N=34; Completed; Sponsor: Unum Therapeutics Inc.; Active, not recruiting ➔ Completed; N=54 ➔ 34

Clinical • Combination therapy • Enrollment change • Trial completion

ATTCK-17-01t: Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=15; Terminated; Sponsor: Unum Therapeutics Inc.; N=30 ➔ 15; Trial completion date: Mar 2021 ➔ Oct 2019; Active, not recruiting ➔ Terminated; Trial primary completion date: Mar 2020 ➔ Oct 2019; Business reasons

Clinical • Combination therapy • Enrollment change • IO Biomarker • Trial completion date • Trial primary completion date • Trial termination

ATTCK-17-01t: Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=30; Active, not recruiting; Sponsor: Unum Therapeutics Inc.; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed • IO Biomarker

Unum Therapeutics announces new data at the American Society of Hematology (ASH) Annual Meeting (GlobeNewswire) - P1, N=40; NCT03189836; Sponsor: Unum; P1, N=54; ATTCK-20-2 (NCT02776813); Sponsor: Unum; "Unum Therapeutics Inc...announced Phase 1 clinical updates for its Antibody-Coupled T cell Receptor (ACTR) engineered T-cell therapies, ACTR707 and ACTR087, in patients with relapsed or refractory CD20+ non-Hodgkin Lymphoma (r/r NHL) at the ASH Annual Meeting, being held December 7-10, in Orlando, FL."

P1 data

Unum Therapeutics Reports Second Quarter 2019 Financial Results and Provides Corporate Updates (GlobeNewswire, Unum Therapeutics Inc.) - "Phase 1 trial (ATTCK-34-01) with ACTR707 in HER2+ advanced solid tumor cancers ongoing: Unum plans to report updates from the ATTCK-34-01 trial including patient enrollment status and preliminary safety data at the end of 2019; Dose escalation continuing in Phase 1 (ATTCK-17-01) trial in multiple myeloma: Unum expects to report data from multiple dose cohorts in the second half of 2019; Treatment continuing for responding patients in Phase 1 (ATTCK-20-2) trial in non-Hodgkin lymphoma: Unum continues to work closely with the FDA to further review these events and plans to report data from the ATTCK-20-2 trial at the end of 2019."

Clinical data • Enrollment status • Trial status

Unum Therapeutics Announces Regulatory Update from Phase 1 Trial with ACTR087 (GlobeNewswire, Unum Therapeutics Inc.) - "Unum Therapeutics Inc...announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Phase 1 trial (ATTCK-20-2) evaluating Unum’s ACTR087 in combination with rituximab following lymphodepleting chemotherapy with fludarabine and cyclophosphamide in patients with relapsed/refractory CD20+ B cell non-Hodgkin lymphoma (r/r NHL)....Unum will continue to work closely with the FDA to further review these events and continues to plan to report data from the ATTCK-20-2 trial at the end of 2019."

Clinical data • Regulatory

Unum Therapeutics reports first quarter 2019 financial results and provides business update (GlobeNewswire) - “Expansion Cohort in ATTCK-20-2 Phase I Trial in Non-Hodgkin Lymphoma Ongoing: Unum plans to report data on all enrolled patients from ATTCK-20-2 at the end of 2019. These findings will be used to advise other ACTR programs, in particular ATTCK-17-01, an ongoing Phase I trial of ACTR087 in combination with SEA-BCMA; Dose Escalation in ATTCK-17-01 Phase I Trial in Multiple Myeloma Continuing: Unum expects to continue to enroll and dose patients through the dose escalation phase of the trial and to report data from multiple dose cohorts in the second half of 2019.”

Enrollment status • P1 data

UT-201501;ATTCK-20-2t: Study of ACTR087 in Subjects With Relapsed or Refractory B-cell Lymphoma (clinicaltrials.gov) - P1; N=54; Active, not recruiting; Sponsor: Unum Therapeutics Inc.; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed

Unum Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Business Update (GlobeNewswire, Unum Therapeutics Inc.) - "Continuing Dose Escalation in ATTCK-20-03 Phase I Trial: Following completion of the dose escalation phase of the trial, Unum plans to initiate a cohort expansion at the preliminary recommended Phase 2 dose of ACTR707 in the second half of 2019; Completed Enrollment of ATTCK-20-2 Phase I Trial: Unum plans to report data on all enrolled patients from ATTCK-20-2 at the end of 2019; Continuing Dose Escalation with ATTCK-17-01 Phase I Trial: Unum expects to continue to enroll and dose patients through the dose escalation phase of the trial and to report data from multiple dose cohorts in the second half of 2019; Initiated ATTCK-34-01 Phase I Trial in Solid Tumors: Unum plans to report initial clinical data from the ongoing dose escalation at the end of 2019." Completed Enrollment of ATTCK-20-2 Phase I Trial: Completed Enrollment of ATTCK-20-2 Phase I Trial: Completed Enrollment of ATTCK-20-2 Phase I Trial:"

Enrollment closed • Enrollment status • P1 data • Trial status