Avalon GloboCare seeking to tap the power of cells to fight cancer and coronavirus

Specializes in developing cell-based technologies and manages stem-cell banks and clinical laboratories Creates proprietary diagnostic and therapeutic products leveraging regenerative medicine and exosome technology Also helping in the fight against coronavirus (COVID-19) What Avalon GloboCare does: Avalon GloboCare Corp (NASDAQ:AVCO) specializes in developing cell-based technologies but is also involved in the management of stem-cell banks and clinical laboratories and the fight against coronavirus (COVID-19). Via its two platforms, Avalon Cell and Avalon Rehab, the company develops proprietary diagnostic and therapeutic products leveraging regenerative medicine and exosome technology. It markets proprietary exosome isolation systems and related products to hospitals. In layman’s terms, exosomes are akin to powerful messengers (tiny, membrane-bound vesicles) released by cells into biofluids like plasma/serum, urine, and saliva.  Avalon says exosomes, which carry cellular proteins and genetic material, can help fight the progression of certain cancers and act as biomarkers to detect tumors through liquid biopsy tests. The Freehold, New Jersey-based company has also developed proprietary cancer immunotherapy called CAR-T, short for chimeric antigen receptor therapy. CAR-T involves genetically modifying T-cells, specifically manufactured for each individual patient, to activate the body’s immune system to recognize and destroy cancer cells.  Avalon’s lead CAR-T therapy is AVA-001, which is designed to treat relapsed/refractory B-cell acute lymphoblastic leukemia and non-Hodgkin lymphoma. And the company has developed a number of skincare and wound-healing products that use clinical-grade tissue-specific exosomes as additives. How is it doing: While it has been quiet so far in 2021, Avalon Globocare had a busy time in the final quarter of 2020 In October, the company announced the formation of a strategic collaboration for the global distribution of coronavirus (COVID-19) point-of-care antibody rapid test devices. It noted that the Assure/FaStep COVID-19 IgG/IgM Rapid Test Device is the first serology (antibody) POC test for COVID-19 using fingerstick blood samples approved by the US Food and Drug Administration (FDA). The FDA has issued an emergency use authorization (EUA) for the test device as well as for the Assure/EcoStep COVID-19 IgG/IgM Rapid Test Device. Under the agreement, Adial has granted Avalon non-exclusive, sub-distribution rights worldwide for both tests. As a result of the FDA's EUA, fingerstick blood samples can now be utilized with the FaStep COVID-19 IgG/IgM Rapid Test Device for the test in POC settings, including doctors' offices, hospitals, urgent care centers, emergency rooms, or other locations where there is a licensed healthcare professional.  In the December 2020 issue of Nature’s Biopharma Dealmakers, Avalon’s president and CEO, Dr David Jin, highlighted Avalon’s ongoing scientific and clinical developments including a first-in-human trial of a mucosal, intranasal vaccine against SARS-CoV-2 that is planned for early 2021. In September, Avalon had announced the launch of its new allogeneic mesenchymal stromal cell (MSC) therapeutic platform as a potential therapy for COVID-19 which is caused by the SARS-CoV-2 virus. The company said it believes that its MSC platform could offer a unique and efficacious approach to treat the potentially fatal acute respiratory distress syndrome, multi-system inflammatory syndrome and cytokine storm-related to severe cases of COVID-19. In addition to being a potential therapy for COVID-19, the company said the platform would also be developed to treat bone marrow transplant-related complications of acute graft versus host disease (aGVHD). In the December Nature Biopharma Dealmakers issue, Dr Jin also described the company’s innovative, allogeneic mesenchymal stromal cell (MSC) therapy candidate, CB-MSC-1, which possess unique anti-inflammatory and immunomodulatory activities, as well as AVA-001, Avalon’s third-generation CAR T cell therapy that has shown robust activity in patients with relapsed, refractory B cell acute lymphoblastic leukemia in a Phase 1 trial. At the start of October, Avalon said it had 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 had 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. And at the end of December, Avalon also provided an update on its partnership with the Institute for Synthetic Bioarchitectures at the University of Natural Resources and Life Sciences (BOKU) in Vienna, Austria. The collaboration brings together BOKU’s S-layer nanotechnology with Avalon’s expertise in biomanufacturing, cell therapy engineering, and clinical development. Avalon plans to leverage the pioneering work of Professor Uwe B. Sleytr, a world-renowned scientist and pioneer in nanobiotechnology, who is among the foremost experts on basic and applied surface layer (S-layer) technology, and Professor Emeritus in the Department of Nanobiotechnology at BOKU. Professor Sleytr is also a member of Avalon’s Scientific and Clinical Advisory Board. Avalon and BOKU are establishing a state-of-the-art research facility, the Christian Doppler Laboratory, located on the BOKU campus in Vienna, Austria, under the scientific leadership of Professor Eva-Kathrin Ehmoser, the Head of BOKU’s Institute for Synthetic Bioarchitectures and Professor Sleytr, a member of the Austrian Academy of Sciences. In connection with the new facility, Avalon and BOKU have signed a Memorandum of Understanding (MOU) to jointly apply for a matching research grant from the prestigious Christian Doppler Laboratory Foundation. Inflection points: News of first-in-human trial of a mucosal, intranasal vaccine against SARS-CoV-2 planned for early 2021 More details on Assure/FaStep COVID-19 IgG/IgM Rapid Test Device Results from Phase 1 clinical trial of relapsed/refractory B-cell lymphoblastic leukemia treatment, AVA-001 What the boss says: In October's statement announcing the strategic collaboration with Adial Pharmaceuticals, Avalon CEO Dr David Jin said: "We believe there is significant market potential for these differentiated test kits, as these tests are able to detect IgG antibodies at a 98.6% accuracy and IgM antibodies at a 92.9% accuracy and provide results within 10 minutes." "Our goal is to leverage our international distribution network and channel partners to bring the product to market globally, he added. Contact the author at jon.hopkins@proactiveinvestors.com