Benzinga | Oct 1, 2020 09:25AM EDT

Avalon GloboCare Offers Clinical Updates On Its CAR-T Immuno-Oncology, Allogeneic Mesenchymal Stromal Cell Therapy Programs

Avalon GloboCare Corp. (NASDAQ:AVCO), a clinical-stage global developer of cell-based technologies and therapeutics, today provided a clinical update on its chimeric antigen receptor (CAR) T-cell therapy and allogeneic mesenchymal stromal cell (MSC) therapy programs following successful completion of its Phase I clinical trial of AVA-001, the Company's leading CAR T-cell therapy candidate in development for patients with relapsed/refractory B-cell lymphoblastic leukemia (R/R B-ALL).

AVA-001

AVA-001 is a third generation CAR T-cell therapy which involves the 4-1BB (or CD28) co-stimulation signaling pathway, which we believe is designed to confer a more effective capacity for cancer cell-killing compared to older generation CAR T-cell therapies. As previously announced, Avalon has successfully completed a Phase I first-in-human clinical study of its leading CAR T-cell therapy candidate, AVA-001, for the treatment of R/R B-ALL (National Institute of Health clinical trial registration number: NCT03952923). Ninety percent of R/R B-ALL patients on trial achieved complete remission within one month of AVA-001 treatment and successfully proceeded to a curative-intent allogeneic bone marrow transplant. Accessory laboratory testing that accompanied this pilot clinical study has demonstrated evidence of enhancement in CAR T-cell persistence and protection against CAR T-cell exhaustion.

Given the positive results, Avalon is in the process of advancing AVA-001 CAR T-cell therapy for R/R B-ALL to the next phase of clinical development. In addition, Avalon is expanding its AVA-001 clinical trial to recruit patients with relapsed/refractory Non-Hodgkin lymphoma (R/R-NHL). 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-ALL, NHL and other hematologic malignancies.

CB-MSC-1

Avalon's CB-MSC-1 is an innovative, allogeneic mesenchymal stromal cell (MSC) therapy candidate derived from human cord blood. Avalon plans to develop its MSC platform as a potential therapy for bone marrow transplant-related complications of acute graft-versus-host disease (aGVHD), and for acute respiratory distress syndrome (ARDS) associated with severe respiratory infection including SARS-CoV-2 virus--the causative agent of the ongoing global COVID-19 pandemic.

MSCs are typically isolated from the bone marrow, fat tissue and other tissue types and possess unique anti-inflammatory and immunomodulatory activities. 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.

Avalon has completed pre-clinical studies and the standardized process development for its CB-MSC-1 cell therapy candidate, and anticipates initiation of a first-in-human clinical trial for aGVHD and ARDS during the fourth quarter of 2020. There is a substantial unmet need for the treatment of aGVHD and ARDS. Leveraging the Company's scientific and clinical expertise in cellular therapy and stem cell-derived exosome (ACTEX(tm)) technology, Avalon also plans to initiate a clinical trial of ACTEX-M, the clinical-grade exosomes derived from CB-MSC-1 as a candidate topical treatment for cutaneous aGVHD.

"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," said David Jin, M.D., Ph.D., President and Chief Executive Officer of Avalon. "We are committed to rapidly advancing these product candidates to address important unmet medical needs for patients," said David Jin, M.D., Ph.D., President and Chief Executive Officer of Avalon.