On May 9, 2020 Avalon GloboCare Corp. (NASDAQ: AVCO), a clinical-stage global developer of cell-based technologies and therapeutics, reported that it has achieved significant milestones, advancing its next generation immune cell therapy using FLASH-CAR technology co-developed with the Company’s strategic partner Arbele Limited (Press release, Avalon, MAY 9, 2020, View Source [SID1234609546]). The adaptable FLASH-CAR platform can be used to create personalized cell therapy from a patient’s own cells, as well as off-the-shelf cell therapy from a universal donor.
Currently available Chimeric Antigen Receptor T (CAR-T) cellular immunotherapy involves a patient’s own T-cells—a type of white blood cell that protects against infections and other diseases including cancer—that are turned into personalized cancer fighting cells. The T-cells are removed from the patient, reprogrammed in the lab using a viral vector to target cancer cells, and infused back into the patient as a cancer immunotherapy.

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In contrast to these existing therapies, Avalon’s FLASH-CAR uses next generation CAR technology to modify patients’ T-cells and natural killer (NK) cells using a ribonucleic acid (RNA)-based platform rather than a viral vector. Similar to T-cells, NK cells are a type of white blood cell, also able to attack cancer cells, but utilize different mechanisms. By using RNA molecules rather than a viral vector, Avalon’s RNA-based CAR technology is designed to rapidly create personalized CAR therapies in 1 to 2 days compared to the 10- to 14-day bio-manufacturing time necessary to generate currently available CAR-T cellular immunotherapy. Avalon’s FLASH-CAR technology is also designed to reprogram the immune cells to hone in on multiple crucial cancer cell targets, called tumor antigens, to potentially achieve superior therapeutic effect. Avoiding the use of viral vectors and complicated bio-processing procedures significantly reduces manufacturing costs, resulting in a more affordable and potentially breakthrough therapy for cancer patients. The FLASH-CAR technology can also be used to generate "off-the-shelf", universal cell therapy that has the potential to reach even more patients.

Avalon’s first FLASH-CAR platform candidate, AVA-011, targets both CD19 and CD22 tumor antigens on cancer cells. Pre-clinical research on AVA-011, including tumor cytotoxicity studies, has been successfully completed and Avalon is immediately entering the process development stage to generate clinical-grade CAR-T and CAR-NK cells for use in human clinical trials. Avalon and Arbele have jointly filed for USPTO provisional and PCT patents for this RNA-based CAR platform cellular therapy and for other applications.

Avalon expects to begin a first-in-human clinical trial with AVA-011 for the treatment of relapsed or refractory B-cell lymphoblastic leukemia (B-ALL) and non-Hodgkin lymphoma in the first quarter of 2021. The goal is to use AVA-011 as a bridge to bone marrow stem cell transplant therapy, currently the only curative approach for patients with these blood cancers.

"Avalon GloboCare is committed to decreasing the time it takes to deliver cellular immunotherapies to cancer patients, as well as lowering the cost of manufacturing by building on our unique RNA-based CAR platform that does not require using a viral vector," stated David Jin, M.D., Ph.D., President and Chief Executive Officer of Avalon GloboCare. "We are accelerating our innovative discovery and development plan, as well as delivering precise clinical execution and leadership in cellular immunotherapy. Our pre-clinical studies are encouraging and we are excited for AVA-011 to enter the clinical development stage, including multi-center clinical trials following completion of process development to generate the cell therapy," said Dr. Jin.

"Through this strategic partnership with Avalon GloboCare, we envision an accelerated scientific and clinical development of the RNA-based FLASH-CAR technology platform with great potential to generate "off-the-shelf" immune effector cell therapies to treat both hematologic and solid malignancies," said John Luk, Ph.D., EMBA, President and Chief Executive Officer of Arbele Limited.