ACTR707 / Cogent Biosci - LARVOL DELTA

Results from a Phase 1 Study of ACTR707 in Combination with Rituximab in Patients with Relapsed or Refractory CD20+ B-Cell Lymphoma. (PubMed, Transplant Cell Ther) - "The ATTCK-20-03 trial serves as proof of principle regarding the ACTR approach that could potentially be used with other antibodies targeting other markers in other malignancies. Although the ACTR707 program has been discontinued, these results may support other programs in employing similar novel approaches of antibody-coupled T-cell activation."

Combination therapy • IO biomarker • Journal • P1 data • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • CD20

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

ATTCK-20-03t: Study of ACTR707 in Combination With Rituximab in Subjects With Relapsed or Refractory B Cell Lymphoma (clinicaltrials.gov) - P1; N=26; Terminated; Sponsor: Cogent Biosciences, Inc.; Active, not recruiting ➔ Terminated; Business decision

Clinical • Combination therapy • Trial termination • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CCND1 • PCR

Preliminary Clinical Results of a Phase 1 Study Evaluating the Safety and Anti-Tumor Activity of ACTR707 in Combination with Rituximab in Subjects with Relapsed or Refractory CD20+ B-Cell Lymphoma (ASH 2018) - P1; "Subjects received lymphodepleting chemotherapy (cyclophosphamide 400 mg/m2 and fludarabine 30 mg/m2) for 3 days, followed by rituximab (375 mg/m2) and ACTR707. These results support the continued dose escalation of ACTR707 in combination with rituximab. Updated data, inclusive of preliminary dose level 2 and correlative biomarkers, will be presented."

Clinical • Combination therapy • P1 data • Biosimilar • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Immune Modulation • Immunology • Indolent Lymphoma • Inflammation • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology

Preliminary Clinical Results from a Phase 1 Study of ACTR707 in Combination with Rituximab in Subjects with Relapsed or Refractory CD20+ non-Hodgkin Lymphoma (ASH 2019) - P1; "ACTR707 is in clinical development in combination with rituximab (NCT03189836) or trastuzumab (NCT03680560)...Subjects receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine) for 3 days, followed by rituximab and a single dose of ACTR707... Data available from DL1 through DL3 of ACTR707+rituximab suggest that clinical responses can be achieved without severe T cell-mediated toxicities (eg, CRS and neurotoxicity) that have been reported with other autologous T-cell products. Dose escalation continues at a target dose of 80×106 ACTR+ T cells; enrollment in DL4 (n=6) was recently completed. Updated data, including identified correlates of clinical outcomes, will be presented for DL1 through DL4."

Clinical • Combination therapy • P1 data • Constipation • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Immune Modulation • Inflammation • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia • CD8

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 to host investor event on its efforts to realize the promise of T cell therapies in solid tumors (GlobeNewswire) - P1, N=40; ATTCK-34-01 (NCT03680560); Sponsor: Unum Therapeutics; "Unum Therapeutics Inc...today announced that the Company will host an investor event to discuss its efforts in solid tumors on Monday November 19, 2018, from 8:30 a.m. to 10:00 a.m. ET in New York City...In addition, the Company will discuss the unmet need, clinical validation of ACTR707 and design of the ATTCK-34-01 Phase I trial using ACTR707 in combination with trastuzumab to target HER2-positive advanced cancers."

Clinical protocol • Oncology • Solid Tumor

[VIRTUAL] A phase I open-label dose-escalation study evaluating ACTR707 T cells in combination with trastuzumab in HER2-overexpressing solid tumors. (ASCO 2020) - No abstract available

Clinical • Combination therapy • P1 data • HER-2

ATTCK-20-03t: Study of ACTR707 in Combination With Rituximab in Subjects With Relapsed or Refractory B Cell Lymphoma (clinicaltrials.gov) - P1; N=26; Active, not recruiting; Sponsor: Unum Therapeutics Inc.; Recruiting ➔ Active, not recruiting; N=40 ➔ 26

Clinical • Combination therapy • Enrollment change • Enrollment closed • PCR

Unum racks up yet another FDA hold as it twists its way through a restructuring, looking for a fresh start with a preclinical drug (Endpoints News) - "In a filing with the SEC today, the troubled biotech reported that its experimental therapy ACTR707 — used in combination with rituximab in patients with CD20+ B cell non-Hodgkin lymphoma — may have been responsible for a possible new malignancy. The FDA slapped a partial hold on the study March 4 while the agency and the biotech explore what happened to trigger the Grade 3 SAE."

FDA event

Unum Therapeutics implements strategic restructuring to prioritize efforts on BOXR1030 for the treatment of solid tumor cancers (GlobeNewswire) - "Unum has initiated formal preclinical development activities, including preclinical safety testing and GMP process development, to support filing an IND application for BOXR1030 in late 2020....As part of this effort, and to conserve resources for BOXR1030, Unum is concluding its ACTR707 clinical trials, including the Phase 1 trial (ATTCK-20-03) in combination with rituximab in relapsed/refractory non-Hodgkin lymphoma and the Phase 1 trial (ATTCK-34-01) in combination with trastuzumab to treat advanced HER2+ solid tumor cancers."

IND • Preclinical • Trial status

Unum Therapeutics Provides Updates to its Phase 1 Trial of ACTR707 for HER2+ Solid Tumor Cancers (GlobeNewswire, Unum Therapeutics Inc.) - "Unum Therapeutics...announced it has completed Cohort 1 enrollment with no dose-limiting toxiticies (DLT) observed in the ATTCK-34-01 Phase 1 trial evaluating Unum’s novel Antibody-Coupled T cell Receptor investigational therapy, ACTR707, together with trastuzumab for the treatment of patients with HER2+ advanced cancers. Of the five patients enrolled, three patients received treatment with trastuzumab (1.0 mg/kg weekly) followed by administration of ACTR707 (25 million ACTR707+ T cells) and completed the DLT review period—defined as approximately six weeks post-ACTR707 administration—with no DLTs observed."

Clinical • Enrollment status

Unum Therapeutics provides updates to its phase 1 trial of ACTR707 for HER2+ solid tumor cancers (GlobeNewswire) - “Unum Therapeutics Inc…announced it has completed Cohort 1 enrollment with no dose-limiting toxiticies (DLT) observed in the ATTCK-34-01 Phase 1 trial evaluating Unum’s novel Antibody-Coupled T cell Receptor investigational therapy, ACTR707, together with trastuzumab for the treatment of patients with HER2+ advanced cancers….we look forward to reporting additional data from multiple dose cohorts during 2020.’”

Enrollment status • P1 data

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 Reports First Quarter 2019 Financial Results and Provides Business Update (GlobeNewswire, Unum Therapeutics Inc.) - Dose Escalation in ATTCK-20-03 Phase I Trial in Non-Hodgkin Lymphoma Continuing: Building upon results from the first two dose cohorts presented at the 2018 American Society of Hematology (ASH) Annual Meeting in December, Unum has continued dose escalation in Cohorts 3 and 4 in its ongoing Phase I study of ACTR707 in combination with rituximab in patients with relapsed/refractory CD20+ B cell non-Hodgkin lymphoma (r/r NHL)....Unum plans to complete dose escalation in the second half of 2019 and subsequently to initiate safety expansion at the preliminary recommended Phase II dose of ACTR707. Unum plans to report results from the dose escalation phase in late 2019.

Clinical data • Enrollment status • Preclinical

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