Last month, Avalon successfully completed a Phase I first-in-human clinical study of its leading Chimeric Antigen Receptor T-cell therapy candidate, AVA-001

() updated investors Monday on the progress of its research and development programs in cell therapy and Covid-19-related initiatives and announced the launch of the Avalon Combat Covid-19 Taskforce (ACCT).

We are excited and encouraged by the progress in advancing our scientific and clinical programs targeting immune-oncology and Covid-19, CEO David Jin said in a statement. As an active, clinical-stage company with innovative technology, productive partnerships and exceptional talent, we are committed to delivering effective execution and leadership to combat cancer and Covid-19.

Last month, Avalon successfully completed a Phase I first-in-human clinical study of its leading Chimeric Antigen Receptor (CAR) T-cell therapy candidate, AVA-001.

The group said that nine out of ten patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) achieved complete remission (CR) within a month of receiving one dose.

The drug was generally well tolerated with minimal toxicities and adverse side effects, the company said. No neurotoxicity or greater than Grade-1 cytokine release syndrome was observed in this cohort of patients, and everyone who achieved CR proceeded to allogeneic bone marrow transplants.

Avalons FLASH-CAR uses CAR technology to modify T-cells and natural killer (NK) cells using an RNA-based platform. The technology is able to create personalized CAR therapies in 1 to 2 days compared to the 10 to 14 days usually necessary to generate currently available CAR-T cellular immunotherapy.

FLASH-CAR technology can also reprogram immune cells to hone in on multiple crucial cancer cell targets, or tumor antigens, to potentially achieve superior therapeutic effect. Avoiding the use of viral vectors and complicated bio-processing procedures significantly reduces manufacturing costs, the company noted.

Avalons first FLASH-CAR candidate, AVA-011, targets both CD19 and CD22 tumor antigens on cancer cells. Pre-clinical research, including tumor cytotoxicity studies, has been completed and the company is entering the process development stage to generate clinical-grade CAR-T and CAR-NK cells for use in human trials.

Avalon expects to begin a first-in-human clinical trial with AVA-011 for the treatment of relapsed/refractory B-cell lymphoblastic leukemia and non-Hodgkin lymphoma in the first quarter of 2021. The goal is to apply AVA-011 as a bridge to bone marrow stem cell transplant therapy with curative potential for patients.

Avalon also established the Avalon Combat Covid-19 Taskforce to accelerate scientific/clinical development to help combat the Covid-19 pandemic through a strategic combination of therapeutic and vaccine approaches, such as:

Avalon is working with the Massachusetts Institute of Technology (MIT) to co-develop a therapeutic platform against the cytokine storm, which causes lung damage and other organ failure associated with the coronavirus.

Cytokines are small protein molecules in the body required to regulate and maintain proper physiological functions, but when released in excess (the cytokine storm), damage vital tissues and organs.

Avalons AVA-Trap therapeutic program is currently entering animal model testing followed by expedited clinical studies with the goal of providing an effective therapeutic option to combat COVID-19 and other life-threatening conditions involving cytokine storms, the company said.

Avalon also recently formed a partnership with the University of Natural Resources and Life Sciences (BOKU) in Vienna, Austria last month to co-develop a surface-layer vaccine for SARS-CoV-2, the virus that causes the COVID-19 disease.

The candidate vaccine fuses s-layer viral particle mimic with SARS-CoV-2 spike protein and could be delivered orally or nasally, rather than using an injection. The vaccine is expected to both decrease the severity of a SARS-CoV-2 infection preventing the more severe respiratory inflammation and organ damage and build immunity against the virus, the company said.

Avalon plans to complete the proof-of-concept pre-clinical studies in 2020, followed by a first-in-human clinical study of this candidate vaccine during 2021. The company also plans to utilize s-layer technology to accelerate vaccine programs for other respiratory infections, including strains of the flu, respiratory syncytial virus (RSV) and other viruses.

Contact Andrew Kessel at [emailprotected]

Follow him on Twitter @andrew_kessel

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Avalon GloboCare updates investors on cell therapy and coronavirus programs as it launches COVID-19 taskforce - Proactive Investors USA & Canada