Avalon GloboCare seeks to tap the power of cells to fight cancer

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 Received $20 million credit facility from chairman Daniel Lu 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. Via its two platforms, Avalon Cell and Avalon Rehab, the company also 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 several skincare and wound-healing products that use clinical-grade tissue-specific exosomes as additives. How is it doing: Avalon is a young company as it went public only four years ago. But over the last two years, the company has been ramping up efforts to grow organically through old-fashion marketing efforts as well as through collaborations and partnerships - with a strong emphasis on China where it has two labs.  The group is also nurturing its CAR-T business in China, led by the company’s wholly-owned US subsidiary, Avactis Biosciences. Avactis is tasked with bio-manufacturing, standardization and bio-banking at the Hebei Yanda Lu Daopei Hospital, Avalon’s chief affiliated clinical facility located on the outskirts of Beijing. The hospital has completed over 300 cases of CAR-T therapy. The subsidiary also provides collaborative research and training programs for clinicians and scientists involved in the therapy. Avalon is also involved with another Chinese hospital - Beijing Stomatologica. Its subsidiary, Genexosome Technologies, is working with the hospital to develop the first saliva-based biomarker as a diagnostic and therapeutic target for oral cancer.  This dovetails with a company study showing that the topical application of exosomes released from modified human stem cells can deter the progression of premalignant oral leukoplakia to form oral cancer. Oral leukoplakia is a precancerous lesion that indicates “increased risk” for the development of oral cancer. And Avalon is conducting the first-in-human clinical CAR-T study for relapsed/refractory B-cell acute lymphoblastic leukemia and non-Hodgkin lymphoma using its AVA-001 therapy at both 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. Partnerships are crucial to Avalon’s growth strategy. Most recently, for example, it formed a strategic partnership with China (Nanjing) Cell Valley (CNCV), one of the largest biotech zone initiatives in China. The aim is to cultivate translational research and technological advances in the CellTech industry in China and globally.  Outside of China, the company has sealed several strategic partnerships with a number of US universities and corporations: with Weill Cornell Medical College to co-develop technologies and bio-production of CAR-T therapies; a research and licensing agreement with Massachusetts Institute of Technology to develop technology for cellular therapy; and with GE Healthcare to enhance standardized automation and bio-production for cellular medicines. Avalon has been given access to GE Healthcare’s cell-processing expertise and products.  In addition to its flagship AVA-101 therapy, the company has two other drug candidates in the pipeline.  Avalon said it is developing a clinical-grade, exosome-based therapeutic candidate, AVA-202, and plans to initiate international, multi-centered clinical studies of vascular diseases and wound healing, including treatment of diabetic foot ulcers. The company has further developed a novel therapeutic candidate AVA-201 for oral cancer. To fund its exosome and CAR-T businesses as well as general operations, Avalon in mid-2019 raised $6 million via a direct offering to institutional investors. Recently the company received an infusion of cash as part of a $20 million credit facility from its chairman Daniel Lu and later repurchased all its outstanding warrants for about $1.4 million, which highlights how the company is strengthening its capital structure.  Meanwhile, the company is doing its part to develop therapies and treatments for patients suffering from the effects of the coronavirus (COVID-19). In mid-April, Avalon said it is advancing its immunotherapeutic AVA-Trap technology program towards combating the cytokine storm associated with coronavirus lung damage and mortality. The company has been developing therapies for fighting cytokine storms long before it was linked to lung damage and death in coronavirus cases.  Cytokines are small protein molecules in the body required to help fight bacteria, viruses and other invading organisms. However, in many conditions, including cancer, and autoimmune diseases, cytokines are released in vast excess — which is also known as a cytokine storm — leading to devastating damage to vital tissues and organs. A prime example is the coronavirus-induced cytokine storm, which often leads to acute respiratory distress syndrome, lung fibrosis, multi-organ failure and death. Inflection points: Anticipates finishing AVA-001 therapy study in mid-2020 Expects more first-in-human clinical studies initiated in 2020 and beyond Planning to launch commercial products leveraging its clinical-grade exosome platform What the boss says: “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,” according to Avalon 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."