soficabtagene geleucel (WU CART 007) / Allotera Therapeutics - LARVOL DELTA

Allotera Therapeutics…announced the opening of the minimal residual disease (MRD)-positive cohort of its global pivotal T-RRex study of Soficabtagene Geleucel (Sofi-cel) (Businesswire) - "T-RRex is a global, single-arm, open-label Phase 2 study with a pivotal cohort evaluating Sofi-cel in patients with R/R T-ALL/T-LBL. The study is also evaluating Sofi-cel in patients who are in remission and remain MRD-positive following standard therapy. The study is being conducted at 18 clinical sites in the U.S. and Australia."

Trial status • T Acute Lymphoblastic Leukemia • T Lymphoblastic Lymphoma

Phase 1/2 Dose-Escalation/Dose-Expansion Study of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma (T-ALL/LBL) (ASH 2023) - P1 | "Two different LDC regimens have been tested: standard LDC (fludarabine 30 mg/m2/day x 3 days and cyclophosphamide 500 mg/m2/day x 3 days), and enhanced LDC (eLDC; fludarabine 30 mg/m2/day x 4 days and cyclophosphamide 1000 mg/m2/day x 3 days)...Most (72%; 13/18) pts had G1-2 CRS events; a single G3 CRS event was reported which resolved within 72 hours after receiving tocilizumab, dexamethasone, and low-dose vasopressors...This program advances CAR-T cell therapy in heavily pre-treated patients with R/R T-ALL/LBL. Enrollment is ongoing."

CAR T-Cell Therapy • IO biomarker • P1/2 data • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • CCR7 • CD7

Phase 1/2 Trial of Anti-CD7 Allogeneic WU-CART-007 in patients with Relapsed/Refractory T-cell Malignancies. (PubMed, Blood) - P1/2 | "WU-CART-007 at the RP2D demonstrated a high response rate in patients with relapsed/refractory T-ALL/LBL and has the potential to provide a new treatment option. ClinicalTrials.gov registration: NCT04984356."

Journal • P1/2 data • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • CD7

Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies (clinicaltrials.gov) - P1 | N=6 | Suspended | Sponsor: Washington University School of Medicine | Trial completion date: Jun 2026 ➔ Jun 2027 | Active, not recruiting ➔ Suspended | Trial primary completion date: Jun 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • Trial suspension • Acute Myelogenous Leukemia • Adult T-Cell Leukemia-Lymphoma • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Hepatosplenic T-cell Lymphoma • Leukemia • Lymphoma • Mycosis Fungoides • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Prolymphocytic Leukemia • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • CD7

TRIAL IN PROGRESS: T-RREX - A PIVOTAL PHASE 2 STUDY OF WU-CART-007 (SOFI-CEL), CD7-DIRECTED ALLOGENEIC CAR-T CELL THERAPY, IN PATIENTS WITH R/R T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA/LYMPHOMA (EHA 2026) - P2 | "Results The study is currently open and enrolling (NCT06514794) at 10 sites in the U.S. and Australia. Summary/Conclusion This pivotal study is designed to generate evidence supporting the potential of sofi-cel to address a significant unmet medical need in patients with R/R T-ALL/LBL."

CAR T-Cell Therapy • Clinical • First-in-human • P2 data • Acute Lymphocytic Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Lymphoblastic Lymphoma • Lymphoma • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • CD7

Wugen, Inc…announced that the U.S. Food and Drug Administration (FDA) has selected Sofi-cel, an investigational allogeneic CAR-T cell therapy, to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. (PharmiWeb) - "Participation in the CDRP program is expected to allow Wugen to engage frequently with the FDA on CMC strategy as the company continues to build manufacturing capabilities to advance Sofi-cel toward BLA submission."

FDA event • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma

Children's Hospital Los Angeles Participates in Trial Testing Novel CAR T-Cell Therapy for Children With T-Cell Leukemia (Newswise) - "The phase 2 study is testing a novel, off-the-shelf chimeric antigen receptor (CAR) T-cell therapy called WU-CART-007. Developed by Wugen Inc., the investigational therapy uses CRISPR-Cas9 gene editing and is specifically designed for children and adults with T-cell leukemia and lymphoma."

Trial status • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma

U.S. FDA Grants to Wugen’s WU-CART-007 Breakthrough Therapy Designation for Treatment of Relapsed or Refractory T Cell Acute Lymphoblastic Leukemia / T Cell Lymphoblastic Lymphoma (Businesswire) - "Regulators granted Wugen this designation following their review of data that included results from the global Phase 1/2 clinical trial evaluating Sofi-cel in patients with R/R T-ALL/LBL. The pivotal Phase 2 T-RRex study is a single-arm trial designed to evaluate the safety and efficacy of Sofi-cel in patients with R/R T-ALL/LBL."

Breakthrough therapy • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma

WU-CART-007, a CD7-directed allogeneic CAR-T cell therapy for R/R T-cell acute lymphoblastic leukemia/lymphoma: Phase 1/2 correlative data and long-term follow-up update (ASH 2025) - P2 | "WU-007 demonstrated robust expansion and manageable long-term safety in heavilypretreated patients with R/R T-ALL/LBL. A pivotal Phase 2 trial (T-RRex) is enrolling patients ≥ 1 year oldwith R/R T-ALL/LBL (NCT06514794)."

CAR T-Cell Therapy • IO biomarker • P1/2 data • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Lymphoblastic Lymphoma • Lymphoma • Rheumatology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • CD7 • CXCL9 • IFNG • IL15 • IL2 • TNFA

Results from the Phase 1/2 Trial are a Foundation for the Ongoing Pivotal Study of Soficabtagene Geleucel for R/R T-Cell ALL/ LBL in Pediatric and Adult Patients (The Manila Times) - "Three patients who received a successful allogeneic stem cell transplant in the Phase 1/2 study remain alive approximately two years after Sofi-cel infusion, highlighting the promise of this investigational therapy in a challenging patient population."

P1/2 data • Acute Lymphocytic Leukemia • T-cell Acute Lymphoblastic Lymphoma

WU-CART-007 (WT-7) Is an Effective Treatment for Adolescent Patients with Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma (T-ALL/LBL) – Subgroup Analysis of WU-CART-007 1001 (ASH 2024) - P1, P2 | "In the Phase 2 portion, pts received 900M WT-7 cells on Day 1 following lymphodepleting chemotherapy (fludarabine 30 mg/m2/day x 4 days and cyclophosphamide 1000 mg/m2/day x 3 days). Given these promising results, the follow up Phase 2 trial will expand enrollment to include children 1 year of age and above, with the potential to open an exploratory cohort with patients with MRD positive disease following induction and consolidation chemotherapy will be initiated after additional safety data is collected in the R/R population. This study, NCT06514794, will begin enrolling in late 2024."

Clinical • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Colorectal Cancer • Graft versus Host Disease • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Leukemia • Lymphoma • Oncology • Rare Diseases • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • CD7

WU-CART-007 (WT-7), an Allogeneic CAR T-Cell Targeting CD7 in Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LBL): Phase 2 Results (ASH 2024) - P1, P2 | "In the Phase 2 portion, pts received a single infusion of 900 million WT-7 cells on Day 1 following enhanced lymphodepleting (eLD) chemotherapy (fludarabine 30 mg/m2/day x 4 days and cyclophosphamide 1000 mg/m2/day x 3 days)...Cytokine Release Syndrome (CRS) occurred in 13/13 (100%) pts; most (69%; 9/13) had G1-2 CRS events; four (31%) pts had G≥3 CRS, which was managed with steroids (75%), tocilizumab (100%), anakinra (25%)...WT-7 has demonstrated evidence of anti-leukemic activity with an acceptable safety profile in heavily pre-treated R/R T-ALL/LBL pts. A follow up study, NCT06514794, in R/R T-ALL/LBL including pediatric pts 1 year of age and older will begin enrolling in late 2024; exploratory MRDpos cohort may be initiated after safety is confirmed in the R/R setting."

CAR T-Cell Therapy • P2 data • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Oncology • Otorhinolaryngology • Pediatrics • Pneumonia • Respiratory Diseases • Septic Shock • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • CD7

Phase 1 Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients with CD7+ T-Cell Non-Hodgkin Lymphoma (ASH 2024) - P1 | "Patients receive "enhanced" lymphodepletion with fludarabine (30 mg/m2 daily x4) and cyclophosphamide (1000 mg/m2 daily x3) followed by WU-CART-007 infusion 3 days after the last dose of chemotherapy. CONCLUSION : WU-CART-007, a promising therapy in patients with relapsed/refractory T-NHL, has demonstrated early signs of activity in this heavily pretreated patient population. Study enrollment (NCT05377827) is ongoing to determine the safety and preliminary efficacy of WU-CART-007 in patients with CD7+ T-NHL and AML."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Acute Lymphocytic Leukemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Leukemia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Prolymphocytic Leukemia • Rare Diseases • T Acute Lymphoblastic Leukemia • T Cell Non-Hodgkin Lymphoma • T-cell Acute Lymphoblastic Lymphoma • Thrombocytopenia • CD7

WU-CART-007 1001: A Phase 1 Study of of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Wugen, Inc. | Phase classification: P1/2 ➔ P1

Phase classification • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma

WUC007-03: A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (clinicaltrials.gov) - P2 | N=125 | Recruiting | Sponsor: Wugen, Inc. | Active, not recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma

Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Washington University School of Medicine | Recruiting ➔ Active, not recruiting | N=54 ➔ 6

Enrollment change • Enrollment closed • Acute Myelogenous Leukemia • Adult T-Cell Leukemia-Lymphoma • Cutaneous T-cell Lymphoma • Dermatology • Hematological Disorders • Hematological Malignancies • Hepatosplenic T-cell Lymphoma • Leukemia • Lymphoma • Mycosis Fungoides • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Prolymphocytic Leukemia • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • CD7

WU-CART-007 Showed Antileukemic Activity, Acceptable Safety in Relapsed/Refractory T-ALL/LBL (Oncology Nurse Advisor) - P1/2 | N=29 | NCT04984356 | Sponsor: Wugen, Inc. | "In patients with relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL), treatment with WU-CART-007 was associated with antileukemic activity and an acceptable safety profile in a recent phase 2 study....Among 11 evaluable patients, the objective response rate (ORR) was 91%, with a composite complete remission (CRc) rate of 73%, including 6 complete remissions (CRs) and 2 CRs with incomplete recovery (CRi). Among 6 patients with CRc and available minimal residual disease (MRD) data, the rate of MRD negativity was 83%. Five participants proceeded to allo-HSCT. The median duration of response was not reached (95% CI, 0.5-not estimable; range, 0.5-9.1 months) at the time of reporting, with a follow-up of up to 9.9 months."

P1/2 data • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma

WUC007-03: A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (clinicaltrials.gov) - P2 | N=125 | Active, not recruiting | Sponsor: Wugen, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma

Wugen Announces Dosing of First Patients in Pivotal Trial of Off-the-Shelf, Allogeneic, CD7-Targeted CAR-T Cell Therapy WU-CART-007 (GlobeNewswire) - "Wugen, Inc...today announced the dosing of the first patients in its pivotal Phase 2 study evaluating WU-CART-007, a potential first-in-class, investigational, anti-CD7 CAR-T cell therapy for pediatric and adult patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL)."

Trial status • T Lymphoblastic Lymphoma • T-cell Acute Lymphoblastic Lymphoma

WU-CART-007, an Allogeneic CAR T-Cell Targeting CD7 in Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LBL): Phase 2 Results (TCT-ASTCT-CIBMTR 2025) - P1/2, P2 | "Patients in phase 2 received a single infusion of 900 million WU-CART-007 cells on Day 1 following lymphodepleting chemotherapy (fludarabine 30 mg/m2/day x 4 days and cyclophosphamide 1000 mg/m2/day x 3 days)...Cytokine Release Syndrome (CRS) was observed in 100% (13/13), mostly Grade ≤ 2 (69%); four (31%) had ≥ Grade 3, managed with steroids (75%), tocilizumab (100%), anakinra (25%)...WU-CART-007 demonstrated anti-leukemic activity with an acceptable safety profile in heavily pre-treated R/R T-ALL/LBL pts. A follow-up study (NCT06514794) including patients > 1 year old and an exploratory MRDpos cohort will begin enrolling in late 2024."

CAR T-Cell Therapy • P2 data • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Oncology • Septic Shock • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • CD7

WUC007-03: A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy inT-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (clinicaltrials.gov) - P2 | N=125 | Recruiting | Sponsor: Wugen, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma

WU-CART-007 Is an Effective Treatment for Adolescent Patients with Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma (T-ALL/LBL) – Subgroup Analysis of WU-CART-007 1001 (TCT-ASTCT-CIBMTR 2025) - P1/2, P2 | "Adolescent patients 12-18 years old were enrolled in Phase 2 and received 900M WU-CART-007 cells on Day 1 following lymphodepleting chemotherapy (fludarabine 30 mg/m2/day x 4 days and cyclophosphamide 1000 mg/m2/day x 3 days). WU-CART-007 has shown efficacy and an acceptable safety profile in adolescent patients with R/R T-ALL/LBL. These promising results support the follow up Phase 2 trial to include children aged 1 year and above, with a potential exploratory cohort for patients with MRD positive disease after induction and consolidation chemotherapy."

Clinical • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Colorectal Cancer • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Leukemia • Lymphoma • Oncology • Rare Diseases • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • CD7

Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: Washington University School of Medicine | Active, not recruiting ➔ Recruiting

CAR T-Cell Therapy • Enrollment open • Acute Myelogenous Leukemia • Adult T-Cell Leukemia-Lymphoma • Cutaneous T-cell Lymphoma • Dermatology • Hematological Disorders • Hematological Malignancies • Hepatosplenic T-cell Lymphoma • Leukemia • Lymphoma • Mycosis Fungoides • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Prolymphocytic Leukemia • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • CD7

Wugen to Present Clinical Data at the 2024 ASH Annual Meeting Ahead of Pivotal Trial Launch of Off-the-Shelf, Allogeneic, CD7-Targeted CAR-T Cell Therapy WU-CART-007 (GlobeNewswire) - P1/2 | N=29 | NCT04984356 | Sponsor: Wugen, Inc. | "Results from Phase 1/2 showed continued anti-leukemic activity and clinically manageable safety in adults and adolescents. WU-CART-007 is an investigational, potential first-in-class, allogeneic, anti-CD7 CAR-T cell therapy under evaluation for treatment of patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL). Based on findings to date with WU-CART-007, including this week’s data, Wugen will initiate the first pivotal Phase 2 study for an off-the-shelf CD7-targeted CAR-T cell therapy."

P1/2 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Oncology

Wugen to Present Clinical Data at the 2024 ASH Annual Meeting… (GlobeNewswire) - "Researchers will present Phase 1/2 updates and studies for its investigational cell therapies this week...'At this year’s ASH meeting, we will present clinical data from adult and adolescent patients that support our soon to open pivotal trial for patients with relapsed or refractory T-ALL/LBL'...The pivotal Phase 2 study is a single-arm trial evaluating the efficacy and safety of WU-CART-007 in patients with R/R T-ALL/LBL and T-ALL/LBL...Wugen researchers will also present the following abstracts for the company’s investigational memory natural killer cell therapy, WU-NK-101"

Clinical data • Acute Myelogenous Leukemia • T Acute Lymphoblastic Leukemia