Avalon GloboCare initiates first-in-human Phase I clinical trial in China of AVA-001

Avalon GloboCare Corp (NASDAQ:AVCO) announced Thursday it has initiated its first-in-human Phase I clinical trial of its flagship AVA-001 therapy in China to treat relapsed/refractory B-cell malignancies, including B-cell lymphoblastic leukemia and non-Hodgkin’s Lymphoma.

The clinical trial of AVA-001, which is a leverage individualized CAR (Chimeric Antigen Receptor) T-cell therapy candidate for immuno-oncology, is being conducted at the Hebei Yanda Lu Daopei Hospital and Beijing Lu Daopei Hospital in China, the world’s single largest CAR-T treatment network with over 600 patients.

CAR-T cells are engineered to express a receptor that recognizes a specific cancer surface target to attack. 

READ: Avalon GloboCare scores $20M credit facility from Chairman Daniel Lu

Unlike traditional small molecule or biologic treatments, the autologous CAR-T therapies are specifically manufactured for each individual patient. 

Avalon GloboCare said AVA-001 was designed to provide a more powerful, personalized CAR delivery mechanism.

Co-developed with China Immunotech Co Ltd, AVA-001 is considered to be a second-generation CAR-T using the 4-1BB (CD137), a co-stimulatory signaling pathway, which exhibited strong anti-cancer activity during a pre-clinical study. It is also expected to feature a shorter bio-manufacturing time.

According to a statement, the production process starts with the extraction of T cells from an individual patient, which are then converted into CAR-T cells that are specifically targeted to recognize and destroy cancer cells.

Avalon GloboCare said it anticipates AVA-001 will entail a shortened bio-production cycle, which could potentially empower clinicians to provide accelerated treatment to patients with hematologic malignancies.  

The company, based in Freehold, New Jersey, expects to recruit 20 patients for clinical safety and efficacy monitoring and assessment.

“We have successfully evolved into an active clinical-stage company with a primary focus on immune effector cell therapy in the oncology domain. As our first-in-human clinical trial, the study of AVA-001 marks a significant milestone for Avalon,” said CEO Dr David Jin.

“We are committed to delivering precise clinical execution and leadership in cell-based therapeutics with a strong pipeline of additional cellular immunotherapy candidates.” 

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Story by ProactiveInvestors