Dilanubicel

SEATTLE, June 15, 2018 (GLOBE NEWSWIRE) -- Nohla Therapeutics, a leading developer of universal, off-the-shelf cell therapies for patients with hematologic malignancies and other critical diseases, today announced the presentation of dilanubicel (NLA101) data demonstrating rapid immune recovery and improved long-term outcomes in Hematopoietic Stem Cell Transplant (HSCT) patients at the 23rd Congress of European Hematology Association (EHA) Annual Conference in Stockholm. Rapid Immune Recovery The data presented at EHA demonstrates that Nohla’s dilanubicel cell therapy, when added to a myeloablative cord blood transplant, significantly improved hematopoietic recovery with no incidence of transplant-related mortality (0% vs. 16% in a concurrent control group) or severe acute Graft-Versus-Host Disease, or GVHD (0% vs. 29% in a concurrent control group). Improved Long-term Outcomes In addition, data presented showed that dilanubicel treatment substantially improved long-term overall survival in patients undergoing a cord blood transplant compared to a concurrent control group (87% vs 66%), with a median follow up of 6.5 years. Of the 13 evaluable patients in the dilanubicel cohort, 9 patients (69%) no longer required immunosuppression within 2 years following transplant. GVHD Relapse-Free Survival (GRFS) is a novel composite endpoint developed by the Blood and Marrow Transplant Clinical Trials Network to measure recovery and long-term survival without ongoing major morbidity or relapse after HSCT. In addition to improved immune recovery and long-term survival, data were also presented measuring GRFS in patients who received dilanubicel. Patients who received dilanubicel in combination with a cord blood transplant were shown to have significantly improved GRFS compared to the concurrent control group (67% vs. 28%). “Evaluation of allogeneic hematopoietic cell transplant success is commonly assessed as incidence of individual complications and treatment failures,” said Colleen Delaney, MD, MSc, Chief Medical Officer and Co-founder of Nohla Therapeutics. “The GRFS endpoint provides a more complete measurement of transplant success and long-term recovery that, along with survival, also accounts for complications such as GVHD and disease relapse. When evaluating dilanubicel data using this composite benchmark, we observed a compelling improvement for patients receiving dilanubicel compared to the concurrent control group. Our ongoing randomized phase 2b study will also evaluate this important endpoint, and we look forward to these results later this year.” About Dilanubicel The company’s lead product candidate, dilanubicel, is currently under evaluation in two ongoing Phase 2 trials. A Phase 2b randomized trial (NCT01690520), has completed enrollment of 160 patients with hematologic malignancies undergoing a myeloablative allogeneic cord blood transplant with or without dilanubicel. In addition, the global Phase 2 LAUNCH trial (NCT03301597) is currently enrolling AML patients at risk for chemotherapy-induced myelosuppression. Dilanubicel is a universal donor, off-the-shelf, ex vivo expanded hematopoietic stem and progenitor cell investigational product intended to provide rapid, transient hematopoiesis with long-term immunologic benefits. Unlike autologous or patient-specific allogeneic cell therapies, dilanubicel does not require Human Leukocyte Antigen (HLA) tissue matching. Intentionally developed to provide short-term, temporary bone marrow function until a patient’s immune system recovers, dilanubicel may also induce long-term immunologic benefits with the potential for improved survival. Dilanubicel is manufactured ahead of time, cryopreserved, and intended for immediate off-the-shelf use. About Nohla Therapeutics Nohla Therapeutics is a leading developer of off-the shelf cell therapies for patients with cancer and other critical diseases. Nohla’s proprietary notch ligand technology platform serves as the foundation for its ongoing clinical, preclinical and discovery programs. The company’s lead product candidate, dilanubicel, is currently under evaluation in two ongoing Phase 2 trials. Nohla is also pursuing multiple preclinical and discovery programs in the areas of immune tolerance and other diseases. More information is available at . Nohla Contact: Jim DeNike Senior Director, Corporate Development & Investor Relations 206.519.5294