dilanubicel (DVX101) / Deverra Therapeutics - LARVOL DELTA

Dilanubicel Improves Single Cord Blood Transplantation: Updated Results with a Larger Cohort (ASGCT 2025) - "Conditioning regimens included FLU/TBI/CY (n=11) or FLU/TBI/CY/Thiotepa (n=11)...GVHD prophylaxis included cyclosporine and mycophenolate mofetil... Relapse remains one of the main causes for treatment failure following stem cell transplant. The addition of Dilanubicel as an adjuvant transient graft in single CBT was found to be safe and led to excellent outcomes, including low relapse rate and no grade III-IV acute or chronic GVHD. Importantly, as a cryopreserved and off-the-shelf, non-HLA-matched allogeneic cell therapy, dilanubicel readily accessible for all patients and easily integrated into standard CBT."

Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • Transplantation • CD34 • CD8

NCI-2017-02205: Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes (clinicaltrials.gov) - P2 | N=35 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | Trial completion date: Mar 2027 ➔ Sep 2027 | Trial primary completion date: Mar 2025 ➔ Nov 2025

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • CD34 • HLA-B • HLA-DRB1

Dilanubicel, a Non-HLA-Matched Pooled Universal Product, Transforming Single Cord Blood Transplantation Success Rates (ASH 2024) - "Patients received conditioning with either FLU 75mg/m2, TBI 13.2 Gy, CY120 mg/kg (n=8) or with FLU 150mg/m2, TBI 4Gy, CY 50 mg/kg and Thiotepa 10 mg/kg (n=7)...Graft versus host disease (GVHD) prophylaxis consisted of Cyclosporine and Mycophenolate Mofetil...With a significant follow-up, the observation of no relapses may be related to the infusion of 3rd party donor APCs for presentation of MHC and activation of donor T cell responses. These promising results warrant further biological investigations and evaluation in a larger study."

Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Oncology • Transplantation • CD14 • CD33 • CD34 • CD8

NCI-2017-02205: Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes (clinicaltrials.gov) - P2 | N=35 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | N=20 ➔ 35 | Trial completion date: Oct 2026 ➔ Mar 2027 | Trial primary completion date: Dec 2024 ➔ Mar 2025

Enrollment change • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • CD34 • HLA-B • HLA-DRB1

NCI-2017-02205: Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | Trial completion date: Jun 2026 ➔ Oct 2026

Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • CD34 • HLA-B • HLA-DRB1

Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers (clinicaltrials.gov) - P2 | N=1 | Terminated | Sponsor: Fred Hutchinson Cancer Center | The study was originally intended to be multi-site but was only conducted at the lead site. Due to the rarity of the subject population & smaller # of enrolling sites, we were not able to reach accrual goals.

Enrollment change • Trial termination • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Anemia • Bone Marrow Transplantation • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Leukemia • Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | Trial primary completion date: Dec 2024 ➔ Jun 2024

Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Anemia • Bone Marrow Transplantation • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Leukemia • Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

Deverra Therapeutics Granted FDA Fast Track Designation for DVX101 (Dilanubicel) for the Treatment of Acute Myeloid Leukemia (ACCESSWIRE) - "Deverra Therapeutics...announced that the U.S. Food and Drug Administration (FDA) granted Fast Track (FT) designation to dilanubicel, the Company's lead candidate for the treatment of newly diagnosed acute myeloid leukemia (AML) to improve response with first-line therapy."

Fast track designation • Acute Myelogenous Leukemia

Deverra Therapeutics Granted FDA Regenerative Medicine Advanced Therapy and Orphan Drug Designations for DVX101 (Dilanubicel) for the Treatment of Acute Myeloid Leukemia (ACCESSWIRE) - "Deverra Therapeutics...announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT)designation to its lead candidate (dilanubicel) for use in first-line treatment for acute myeloid leukemia (AML). The FDA Center for Biologics Evaluation and Research (CBER) granted RMAT designation based on the potential of DVX101 (dilanubicel) to address the significant unmet medical need in treatment of patients with newly diagnosed AML, where the 5-year overall survival rate remains less than 30%. Dilanubicel was recently granted orphan drug designation (ODD) for the treatment of AML."

FDA event • Orphan drug • Acute Myelogenous Leukemia

Orphan Designation: Treatment of acute myeloid leukemia (FDA) - Date Designated: 02/26/2024

Orphan drug • Acute Lymphocytic Leukemia

NCI-2017-02205: Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | Suspended ➔ Recruiting | N=15 ➔ 20

Enrollment change • Enrollment open • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • CD34 • HLA-B • HLA-DRB1

Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | Trial primary completion date: Nov 2022 ➔ Dec 2024

Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Anemia • Bone Marrow Transplantation • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Leukemia • Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

NCI-2017-02205: Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | Trial completion date: Oct 2025 ➔ Jun 2026 | Trial primary completion date: Oct 2023 ➔ Oct 2024

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • CD34 • HLA-B • HLA-DRB1

NCI-2017-02205: Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | Trial completion date: Jun 2025 ➔ Oct 2025 | Trial primary completion date: Jun 2023 ➔ Oct 2023

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • CD34 • HLA-B • HLA-DRB1

Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Preclinical • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • CD34 • HLA-B • HLA-DRB1

Donor Umbilical Cord Blood Transplant With or Without Ex-vivo Expanded Cord Blood Progenitor Cells in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, or Myelodysplastic Syndromes (clinicaltrials.gov) - P2; N=163; Completed; Sponsor: Nohla Therapeutics, Inc.; Active, not recruiting ➔ Completed

Preclinical • Trial completion • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation

Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes (clinicaltrials.gov) - P2; N=15; Recruiting; Sponsor: Nohla Therapeutics, Inc.; Not yet recruiting ➔ Recruiting; Trial completion date: Mar 2022 ➔ Aug 2021; Initiation date: May 2018 ➔ Oct 2018; Trial primary completion date: Mar 2022 ➔ Jan 2020

Clinical • Enrollment open • Preclinical • Trial completion date • Trial initiation date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • CD34 • HLA-DRB1

Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes (clinicaltrials.gov) - P2; N=15; Suspended; Sponsor: Nohla Therapeutics, Inc.; Recruiting ➔ Suspended

Clinical • Preclinical • Trial suspension • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • CD34 • HLA-DRB1

Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes (clinicaltrials.gov) - P2; N=15; Not yet recruiting; Sponsor: Fred Hutchinson Cancer Research Center; Trial completion date: Aug 2021 ➔ Jun 2025; Trial primary completion date: Jan 2020 ➔ Jun 2023

Clinical • Preclinical • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • CD34 • HLA-DRB1

Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: Nohla Therapeutics, Inc.; N=15 ➔ 0; Suspended ➔ Withdrawn

Clinical • Enrollment change • Preclinical • Trial withdrawal • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • CD34 • HLA-DRB1

Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes (clinicaltrials.gov) - P2; N=15; Not yet recruiting; Sponsor: Fred Hutchinson Cancer Research Center

Clinical • New P2 trial • Preclinical • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Disorders • Myelodysplastic Syndrome • Transplantation • CD34 • HLA-DRB1

LAUNCH: NLA101 in Adults Receiving High Dose Chemotherapy for AML (clinicaltrials.gov) - P2; N=220; Recruiting; Sponsor: Nohla Therapeutics, Inc.; Not yet recruiting ➔ Recruiting; Initiation date: Oct 2017 ➔ Jan 2018

Enrollment open • Trial initiation date • Acute Myelogenous Leukemia • Biosimilar • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

LAUNCH: NLA101 in Adults Receiving High Dose Chemotherapy for AML (clinicaltrials.gov) - P2; N=146; Terminated; Sponsor: Nohla Therapeutics, Inc.; Active, not recruiting ➔ Terminated; Development plan under review.

Clinical • Trial termination

LAUNCH: NLA101 in Adults Receiving High Dose Chemotherapy for AML (clinicaltrials.gov) - P2; N=146; Active, not recruiting; Sponsor: Nohla Therapeutics, Inc.; Recruiting ➔ Active, not recruiting; N=220 ➔ 146

Clinical • Enrollment change • Enrollment closed