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NASDAQ Biotech AVCO makes Big Moves Filing 16 New Patent Applications, Co-Inventors are leading International Universities and Cellular Therapy Developers; Avalon Globocare Corp. (NASDAQ: AVCO)

NASDAQ Biotech AVCO makes Big Moves Filing 16 New Patent Applications, Co-Inventors are leading International Universities & Cellular Therapy Developers; Avalon Globocare Corp. (NASDAQ: AVCO)

Patent applications cover three types of cellular therapies and related technologies

– Clinical-Stage CellTech Developer Dedicated to Immune Effector Cell Therapy and Exosome Technology.
– Life Saving COVID-19 Diagnostics and Therapeutics.
– New Treatment for Deadly Cytokine Storm in COVID-19 Patients.
– Filing of 16 New Patent Applications Covering Three Types of Cellular Therapies and Related Technologies.
– Expansion of Cellular Immuno-Oncology Platform with Novel Chimeric Antigen Receptor-Natural Killer (CAR-NK) Cell Therapies.
– Chairman Converts $3.0 Million of Debt into AVCO Common Stock at $1.25 Per Share.
– Advancement of AI-Enhanced Protein Design Technology for Cellular Therapy Development.

Avalon GloboCare Corp. (NASDAQ: AVCO) is a clinical-stage, vertically integrated, leading CellTech bio-developer dedicated to advancing and empowering innovative, transformative immune effector cell therapy, exosome technology, as well as COVID-19 related diagnostics and therapeutics. AVCO also provides strategic advisory and outsourcing services to facilitate and enhance its clients’ growth and development, as well as competitiveness in healthcare and CellTech industry markets. Through its subsidiary structure with unique integration of verticals from innovative R&D to automated bioproduction and accelerated clinical development, AVCO is establishing a leading role in the fields of cellular immunotherapy (including CAR-T/NK), exosome technology (ACTEX), and regenerative therapeutics.

– Advanced Filtration Tech Could Help Stop Life-Threatening Cytokine Storm in COVID-19 Patients

Cytokine storm has made frequent appearances in the news lately as a life-threatening complication in patients suffering from COVID-19. The condition is an inflammatory syndrome triggered by hyperactivation of immune cells that can significantly impact the patient’s chances of making a full recovery or surviving the infection at all.

Fortunately, AVCO has already been developing a range of therapies that have the potential to help target cytokine storm and other risk factors that make the widespread virus so difficult to get under control.

What Is Cytokine Storm?

The immune system uses cytokines to perform a variety of important tasks from clotting blood to triggering antibody production. When overworked — as can happen when the body is fighting off an aggressive, difficult disease like COVID-19 or is being treated with therapies designed to activate an immune response — that same immune system can end up producing too many cytokines. When the ones that trigger an inflammatory response are produced in excess, the cytokines trigger severe inflammatory symptoms, damage healthy tissue, and can even cause multiple organs to fail, leading to death.

AVCO AVA-Trap(TM) Already Targets Cytokine Storm

Because cytokine storm is a common risk factor in many cancer therapies, the oncology-focused AVCO was already hard at work on a way to calm down cytokine storms. The AVCO AVA-Trap(TM) therapeutic program was developed to target this potentially fatal complication. By using cytokine receptor proteins, the AVA-Trap(TM) program could dampen the release of cytokine, essentially filtering out the excess cytokines.

When COVID-19 started to spread through populations around the globe in 2020, doctors soon realized that the virus could induce a cytokine storm and that, when it did, the chances of that patient surviving grew slim. AVCO moved quickly to file and expanded patent for the proprietary filtration technology so it could be used to help COVID patients increase their chances of recovering from the disease.

AVCO Launches Full-Scale Plan to Tackle COVID-19 Pandemic

In addition to leveraging its existing AVA-Trap(TM) program to help combat cytokine storm and improve patient outcomes, AVCO also began working on a slate of other tools doctors can use to keep the evolving virus at bay.

In partnership with Adial Pharmaceuticals Inc. (NASDAQ: ADIL), AVCO is distributing a rapid diagnostics test that can detect multiple COVID antibodies with between 92.9% and 98.6% accuracy in just 10 minutes. Using the AVCO existing global distribution network, the 2 companies are able to make this rapid and highly accurate test available to healthcare providers worldwide.

In another partnership with Austria’s University of Natural Resources and Life Sciences (BOKU), AVCO is working on an intranasal spray vaccine for COVID-19.  Based on innovative S-layer technology that creates uniform, repetitive protein structures, the vaccine could become a highly effective formula in a format that people could self-administer — reducing the burden on healthcare providers to individually vaccinate the world’s population and reducing barriers to access for people with mobility challenges or who live too far from the nearest vaccine administration site.

Finally, AVCO began practical testing for its allogeneic MSC-based cellular therapy (ACETEX), which could treat the acute respiratory distress syndrome (ARDS) and multisystem inflammatory syndrome that can also come with severe cases of COVID-19 infection and, like cytokine storm, significantly increase the risk of mortality. ARDS alone has been the cause of death in 70% of fatal COVID-19 cases where an aggressive inflammatory response happens.

ACETEX(TM) uses mesenchymal stromal cells taken from bone marrow, fat tissue, or other tissue types and adapts them to help moderate the body’s immune system response. Because cytokine storm, ARDS, and multisystem inflammatory syndrome in COVID-19 patients are all triggered by a hyperactive immune response, the potential ACETEX(TM) has for better regulating the immune response could offer a reliable treatment option to stop these complications in their tracks and prevent them from progressing to a fatal stage.

– AVCO Expands IP Portfolio, Files 16 New Patent Applications

On April 26th AVCO announced that the Company has jointly filed 16 patent applications, co-invented with key strategic partners, including a top-5 U.S. university, a leading education and research center in Europe, as well as a premier multi-national developer of cellular therapies in the field of oncology. Patents were filed with the U.S. Patent and Trademark Office (USPTO), the China National Intellectual Property Administration (CNIPA), and under the Patent Cooperation Treaty (PCT) covering 36 countries.

The new AVCO intellectual property covers three core patent families:

– Engineering and bio-manufacturing of novel chimeric antigen receptor (CAR) T-cells related to the mRNA-based Flash-CARTM cellular therapy platform. This technology has been applied to Avalon’s AVA-011 CAR-T cell therapy candidate, which is currently at the process development stage to generate cGMP-grade CAR-T cells for upcoming first-in-human clinical trials.

– Soluble, antibody-like cytokine/chemokine decoy receptors derived using the QTY protein design, with potential applications including mitigation of the “cytokine storm” associated with COVID-19 and cellular immunotherapy delivery, as well as broadening the range of therapeutic targets addressable by CAR T-cell therapies.

– Novel S-layer coated emulsome technology (SLET)-derived fusion proteins intended for mucosal vaccine development, which is designed to trigger robust protective immune responses at the predominant sites of pathogen infection. The SLET platform provides a “molecular GPS system” to guide the trafficking and delivery of a payload to a targeted destination in the body.

“These latest patent applications solidify and expand our robust IP portfolio, both in the U.S. and internationally,” said David Jin, M.D., Ph.D., President and Chief Executive Officer of AVCO. “We are especially honored to partner with several leading global academic researchers and institutions in the field of cell therapy, as co-inventors of the technologies. We believe these patent applications will extend our geographic IP protection and are timed to maximize the duration of the patents for decades to come. These patents are within our core competencies in the areas of CAR-T, QTY protein design and S-layer technologies, thereby enhancing our position as a leader in immuno-oncology and cellular medicines. Collectively, we believe each of these patents covers therapies and technologies that target significant addressable markets. They are all supported by strong preclinical data as we rapidly advance towards first-in-human clinical trials.”

– AVCO Expands Cellular Immuno-Oncology Platform with Addition of Novel Chimeric Antigen Receptor-Natural Killer (CAR-NK) Cell Therapies

On February 14th AVCO announced expanding its cellular immuno-oncology program with the addition of novel Chimeric Antigen Receptor – Natural Killer (CAR-NK) cell therapies.

Natural killer (NK) cells constitute an important component of the immune system. NK cells seek out abnormal cells, including cancerous cells, and destroy them. However, cancer cells are often capable of “masking” themselves to evade attack by NK cells. By adding a “Chimeric Antigen Receptor” (CAR) to a patient’s own or universal-donor NK cells, these engineered CAR-NK cells are designed to “unmask,” recognize and destroy a patient’s specific tumor surface targets.

Avalon is leveraging its mRNA-based FLASH-CAR(TM) platform to develop autologous and universal (“off-the-shelf”) CAR-NK technology and cellular therapies for the potential treatment of hematologic malignancies and solid tumors.  AVCO plans to expand its clinical program in collaboration with its major clinical trial partner, the Lu Daopei Hospital.

The new CAR-NK therapies in development are intended to build upon and complement AVA-011, Avalon’s lead CAR-T candidate, part of the Company’s proprietary mRNA-based FLASH-CAR(TM) platform. AVA-011 is currently at the IND-enabling, process development stage, which is expected to produce clinical-grade CAR-T cells for an upcoming clinical trial in patients with hematological malignancies. The platform uses next generation CAR technology to modify patients’ T or universal-donor NK cells using a ribonucleic acid (RNA)-based platform rather than a viral vector, allowing for more rapid and lower-cost bio-manufacturing of the cell therapy products.

To further strengthen its CAR-NK development capabilities, AVCO has appointed Dr. Dongfang Liu to its Scientific and Clinical Advisory Board. Dr. Liu is currently an Associate Professor and Director of Immunoassay Development Program at the Department of Pathology, Immunology and Laboratory Medicine at The Rutgers University New Jersey Medical School. Dr. Liu’s research expertise is focused on the immunobiology of NK and CAR-NK, with more than 20 years of experience in NK cell research. Dr. Liu is a prolific author in top-tier journals including Nature Immunology, Immunity, Nature Medicine, Nature Communications, JACI, and PNAS. Dr. Liu also serves on the editorial boards of several scientific journals and as a reviewer for scientific journals and grant agencies.

– AVCO Chairman Converts $3.0 Million of Debt into Common Stock at $1.25 Per Share Showing Continued Confidence and Support of the Company’s Business

On December 22nd AVCO announced the Company’s Chairman, Daniel Lu, had converted $3.0 million of debt owed to him under the Line of Credit into 2.4 million shares of AVCO common stock at $1.25 per share. The conversion price represents a 45% premium to the previous day’s  closing price.

– AVCO Advances AI-Enhanced Protein Design Technology for Cellular Therapy Development

– AVCO and research partner, Massachusetts Institute of Technology (MIT), combine their protein design “QTY Code” technology with Google’s DeepMind artificial intelligence (AI) program, AlphaFold2, to accurately predict the 3D structures of protein receptors that have potential use as cellular therapy targets

–  A study of the application and capabilities of the dual technology was published in the November 2021 issue of Life, a peer-reviewed life sciences journal

On December 9th AVCO announced further advancement of the Company’s sponsored research and licensing agreement with the Massachusetts Institute of Technology (MIT). Avalon and MIT have combined their artificial intelligence (AI)-enhanced protein design “QTY Code” technology with Google’s AlphaFold2, a DeepMind AI program developed to predict 3-dimensional (3D) protein structures of previously difficult to work with drug targets. This new system is designed to accelerate and advance Avalon’s capabilities in developing novel targets for immuno-oncology and cellular medicine.

The “QTY Code” breakthrough technology, developed by AVCO and the laboratory of Dr. Shuguang Zhang, Ph.D., of MIT’s Media lab in Boston, MA, is a protein-design platform that can turn water-insoluble transmembrane receptor proteins into water-soluble proteins, enabling their use in many clinical applications, including drug development. This program has already successfully generated a series of decoy receptors, which function to soak up excess chemokines and cytokines produced in the body during a potentially fatal ‘cytokine storm.’ These cytokine storms can occur in patients with COVID-19 and in cancer patients being treated with CAR T-cell therapy.

The newly published study demonstrated the utility and efficiency of combining the two AI-based technologies. The researchers used the QTY code technology to design water-soluble versions of chemokine receptors—water-insoluble proteins involved in cytokine storms, cancer, autoimmune diseases and important drug targets—and then used AlphaFold to accurately predict the structures of these clinically important proteins.

Combining the “QTY code” with AlphaFold2, provides Avalon with a novel, accurate, and efficient in-silico tool to improve knowledge about important potential therapeutic targets such as transmembrane receptors and other proteins to better understand their biology and facilitate the development of novel cellular therapies.

“This new study with our collaborator, Dr. Shuguang Zhang from MIT, has validated the innovative application of the QTY code technology to transform important cellular therapy targets that have been previously difficult to work with in the laboratory,” said David Jin, M.D., Ph.D., President and Chief Executive Officer of AVCO. “This new approach is advancing our capabilities in designing novel immuno-oncology and cellular medicine therapies and we are excited to continue to work with Dr. Zhang to advance these drug development technologies,” added Dr. Jin.

The study of the new dual technology application was published in the November 2021 issue of Life, an international, peer-reviewed, open-access life sciences journal.

For more information on Avalon GloboCare Corp. (NASDAQ: AVCO) visit:

http://www.avalon-globocare.com

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