Avalon GloboCare Corp. (Avalon) operates as a clinical-stage, vertically integrated, leading CellTech bio-developer dedicated to advancing and empowering innovative and transformative immune effector cell therapy and laboratory services.
Through the company's membership interest in Lab Services MSO ('Lab Services'), the company plans to focus on precision diagnostics along with toxicology and wellness testing. Through the company's subsidiary structure with unique integration of verticals from...
Avalon GloboCare Corp. (Avalon) operates as a clinical-stage, vertically integrated, leading CellTech bio-developer dedicated to advancing and empowering innovative and transformative immune effector cell therapy and laboratory services.
Through the company's membership interest in Lab Services MSO ('Lab Services'), the company plans to focus on precision diagnostics along with toxicology and wellness testing. Through the company's subsidiary structure with unique integration of verticals from innovative R&D to automated bioproduction and accelerated clinical development, the company is establishing a leading role in the fields of cellular immunotherapy (including CAR-T), and laboratory services.
Laboratory Services is focused on delivering high quality services related to toxicology and wellness testing and provides a broad portfolio of diagnostic tests, including drug testing, toxicology, and a broad array of test services, from general bloodwork to anatomic pathology, and urine toxicology. Specific capabilities include STAT blood testing, qualitative drug screening, genetic testing, urinary testing, sexually transmitted disease testing and more. The panels that the company tests for are thyroid panel, comprehensive metabolic panel, kidney profile, liver function tests, and other individual tests. Through Laboratory Services, the company uses fast, accurate, and efficient equipment to provide practitioners with the tools to quickly determine if a patient is following their designated treatment plan. In most instances, the company is able to provide a practitioner with qualitative drug class results the same day the sample is received. The company provides an extensive chemistry test menu that gives physicians the information to better treat their patients and maintain their overall wellness and have developed a premier reputation for customer service and fast turnaround times in the industry.
The company is also focused on achieving and fostering seamless integration of unique verticals to bridge and accelerate innovative research, bio-process development, clinical programs and product commercialization. Avalon's upstream innovative research includes:
Novel therapeutic and diagnostic targets development utilizing QTY-code protein design technology with Massachusetts Institute of Technology (MIT), including using the QTY code protein design technology for the development of novel therapeutic and diagnostic targets.
Co-development of next generation, mRNA-based (Flash-CARTM) CAR-T, CAR-NK and other immune effector cell therapeutic modalities with Arbele Limited.
Avalon's midstream bio-processing and bio-production facility is affiliated with the University of Pittsburgh Medical Center where the company's leading candidate AVA-011, as described below, is undergoing process development to generate clinical grade CAR-T cells for upcoming clinical trial in the U.S.
Avalon's downstream medical team and facility consists of top-rated affiliated hospital network and experts specialized in hematology, oncology, cellular immunotherapy, hematopoietic stem/progenitor cell transplant, as well as regenerative therapeutics. The company's major clinical programs include:
AVA-001: Avalon has initiated its first-in-human clinical trial of CD19 CAR-T candidate, AVA-001 in August 2019 at the Hebei Yanda Lu Daopei Hospital and Beijing Lu Daopei Hospital in China (the world's single largest CAR-T treatment network for the indication of relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). The AVA-001 candidate (co-developed with China Immunotech Co. Ltd) is characterized by the utilization of 4-1BB (CD137) co-stimulatory signaling pathway, conferring a strong anti-cancer activity during pre-clinical study. It also features a shorter bio-manufacturing time which leads to the advantage of prompt treatment to patients where timing is important related hematologic malignancies. The company has successfully completed the first-in-human clinical trial of the company's AVA-001 anti-CD19 CAR-T cell therapy as a bridge to allogeneic bone marrow transplantation for patients with relapsed/refractory B-ALL at the Lu Daopei Hospital (registered clinical trial number NCT03952923) with excellent efficacy (90% complete remission rate) and minimal adverse side effects. The company is expanding the indication and plan to recuit patients in the USA for AVA-001 to include both relapsed/refractory B-ALL and non-Hodgkin lymphoma patients.
AVA-011 and FLASH-CAR: Avalon advanced its next generation immune cell therapy using mRNA-based, non-viral FLASH-CAR technology co-developed with the company's strategic partner Arbele Limited. 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. The company's leading candidate, AVA-011, is at process development stage to generate clinical-grade cell-therapy products for subsequent clinical studies. In July 2021, the company and the University of Pittsburgh of the Commonwealth System of Higher Education (the 'University') entered into a Corporate Research Agreement (the 'University Agreement'). Pursuant to the University Agreement, for a term of two years the University agreed to use its reasonable efforts to perform academic research funded by the company in connection with the development of point-of-care modular autonomous processing system to generate clinical-grade AVA-011, a RNA-based chimeric antigen receptor (CAR) T-cell therapy candidate with the appointment of Dr. Yen Michael S. Hsu as Principal Investigator. The company is in the process of renegotiating this agreement to extend the term through 2023 and complete some of the research contemplated in the original agreement.
AVA-Trap: Avalon's AVA-Trap therapeutic program plans to enter 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 initiated a sponsored research and co-development project with Massachusetts Institute of Technology (MIT) led by Professor Shuguang Zhang as Principal Investigator in May 2019. Using the unique QTY code protein design platform, six water-soluble variant cytokine receptors have been successfully designed and tested to show binding affinity to the respective cytokines. AVA-Trap can potentially generate novel therapeutic targets for cellular therapy, as well as in the field of precision diagnostics. The company does not have a timeline for the next steps of this study.
China Operations
Due to the winding down of the medical related consulting services segment, in November 2022, the company decided to cease all operations in the People's Republic of China (the 'PRC') with the exception of a small administrative office, in Shanghai. The company, through its Nevada Subsidiary Avactis Biosciences Inc., will continue to own Avactis Nanjing Biosciences Ltd., which only owns a patent and is not considered an operating entity.
Sales and Marketing
The company seeks to develop new business through relationships driven by the company's senior management, which have extensive contacts throughout the healthcare system. The company's senior management will be seeking opportunities for joint ventures, strategic relationships and acquisitions in consulting, biomedical innovations, laboratory, and medical device companies. In addition, through the company's membership interest in Lab Services, the company plans to generate revenue from toxicology and wellness laboratory testing. The company also intends to seek opportunities to expand the operations of Lab Services, through acquisition of additional lab companies and through the opening of new lab locations.
Consulting Services
Due to the winding down of the medical related consulting services in 2022, the company decided to cease all operations of Avalon Shanghai and no longer has any material revenues or expenses in Avalon Shanghai.
Markets
Laboratory Services
Through the company's membership interest in Laboratory Services, the company is focused on delivering high quality services related to toxicology and wellness testing. The company uses fast, accurate, and efficient equipment to provide practitioners with the tools to quickly determine if a patient is following their designated treatment plan. In most instances, the company is able to provide a practitioner with qualitative drug class results the same day the sample is received. The company provides an extensive chemistry test menu that gives physicians the information to better treat their patients and maintain their overall wellness. The panels that the company tests for are thyroid panel, comprehensive metabolic panel, kidney profile, liver function tests, and other individual tests.
Cellular Therapy
The company focuses on the following markets in developing its cellular therapy business:
Cellular Immunotherapy in Oncology: Regarded as the future of medicine, cell-based technologies and therapeutics will replace pharmaceuticals as a more effective and functional modality in certain unmet medical areas. The company is actively engaging in this revolutionary trend and positioning to take a leading role in immune effector cell therapies in the immuno-oncology domai.
QTY-Code Protein Design: Novel therapeutic and diagnostic targets development utilizing QTY-code protein design technology with Massachusetts Institute of Technology (MIT), including using the QTY code protein design technology for the development of a hemofiltration device to treat Cytokine Storm (aka Cytokine Release Syndrome). QTY-code can be applied to generate water-soluble, antibody-like molecular variants of native membrane-bound receptors, which may expand the repertoire of therapeutic targets in CAR-T cell therapies.
Revenue
Avalon RT 9 Properties, LLC
In May 2017, the company acquired commercial property located in Freehold, New Jersey. This property is now the company's corporate headquarters and contains several commercial tenants that generate revenue through rental income.
Laboratory Services
On February 9, 2023, the company acquired membership interest in Lab Services. The company anticipates generating revenue through this membership interest in the areas of toxicology and wellness testing.
Strategic Development
Through the company's wholly owned subsidiary Lab Services, the company plans to embark in a rollup acquisition strategy of small to medium size laboratories accretive to the company's strategy and complimentary to the company's membership interest in Lab Services. The company also intends to pursue the acquisition and development of healthcare related technologies for cell related diagnostics and therapeutics through acquisition, licensing or joint ventures with major universities and biotech companies. seeking laboratory or medical device acquisitions.
Competition
Laboratory Services
The company's largest commercial clinical laboratory competitors are Quest Diagnostic Laboratories and Laboratory Corporation of America.
Government Regulation
The company's pre-clinical and clinical studies must conform to the FDA's Good Laboratory Practice, or GLP, and Good Clinical Practice, or GCP, requirements, respectively, which are designed to ensure the quality and integrity of submitted data and protect the rights and well-being of study patients.
In the U.S., the company's activities are potentially subject to regulation by various federal, state and local authorities in addition to the FDA, including but not limited to, the Centers for Medicare and Medicaid Services, or CMS, other divisions of the U.S. Department of Health and Human Services (such as the Office of Inspector General and the Health Resources and Service Administration), the U.S. Department of Justice, or the DOJ, and individual U.S. Attorney offices within the DOJ, and state and local governments.
Research and Development
The company incurred research and development expense of $731,328 in the year ended December 31, 2022.
History
Avalon GloboCare Corp. was founded in 2016.
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