Avalon GloboCare Corp (NASDAQ:AVCO) announced Thursday that it has expanded the Phase 1 clinical trial of its relapsed/refractory B-cell lymphoblastic leukemia treatment, AVA-001, to include enrollment of patients with relapsed/refractory non-Hodgkin lymphoma.
AVA-001 is a chimeric antigen receptor (CAR) T-cell (a type of white blood cell) therapy and allogeneic mesenchymal stromal cell (MSC, or connective tissue) therapy, which is designed to improve the body’s capacity to kill cancer cells.
In June, Avalon successfully completed a first-in-human trial of the drug, and found that nine out of 10 patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) achieved complete remission within one month.
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Now, the company has completed pre-clinical study and standardized process development for another allogeneic MSC-based cellular therapy candidate, CB-MSC-1. Avalon anticipates initiating a first-in-human clinical trial in patients with acute graft-versus-host disease (aGVHD) and acute respiratory distress syndrome (ARDS) in the fourth quarter of 2020.
ARDS is associated with severe respiratory infection, including SARS-CoV-2, the virus that causes COVID-19.
MSCs are typically isolated from the bone marrow, fat tissue and other tissue types and possess unique anti-inflammatory and immunomodulatory activities, the company said. These cells have the ability to suppress T-cell proliferation, cytokine secretion and regulate the balance of antibody-based and cell-based immune responses. MSCs can also tone down the abnormal release of antibodies from B-cells and cytokines from natural killer cells.
“We are excited and encouraged by the clinical and technological progress we have made with these key cellular programs which are the cornerstone of Avalon,” CEO David Jin said in a statement. “We are committed to rapidly advancing these product candidates to address important unmet medical needs for patients.”
Given the positive results, Avalon is in the process of advancing AVA-001 to the next phase of clinical development. This clinical paradigm of bridging CAR T-cell therapy to bone marrow transplant will provide a new therapeutic horizon with curative potential for patients with relapsed/refractory B-cell lymphoblastic leukemia, non-Hodgkin lymphoma and other hematologic malignancies.
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