As demand for CAR-T sky rockets Gilead and Bristol-Myers Squibb spend hundreds of millions while a sleeping giant makes major headway in research and clinical trials

Keep your eye on is Avalon GloboCare (NASDAQ:AVCO)

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According to STAT news article “Glowing tumor-munching cells, captured on video, show the promise of a new approach to CAR-T cancer therapy”

The studies’ beginnings trace back to 2015, when Roybal, an immunologist-slash-synthetic biologist, was a postdoc in Lim’s lab. Lim had long been tinkering with the genetic programs of bacteria and yeast, prodding them to take on new identities and functions. When CAR-T started to take off, he saw an opportunity to do the same thing with T cells. That first generation of cell-based immunotherapies worked by bestowing T cells with new surface proteins called chimeric antigen receptors (the CAR in CAR-T), allowing them to better recognize and latch onto proteins poking out of cancer cells. But what happens next relies on a T cell’s natural activation program. And in many patients, that drive to kill kicks into overdrive, sparking an indiscriminate assault on healthy cells and leading to dangerous side effects. Lim thought he could tune T cells to be safer and more predictable.

That effort got supercharged when Roybal built a cellular component called synNotch — a receptor that spans the T cell’s outer membrane. When it binds its target, say a protein on the outside of a tumor, a little piece breaks off and makes a beeline for the cell’s nucleus, where it toggles other genes on or off. SynNotch endowed T cells with a new layer of biological logic analogous to an electronic circuit. Instead of just kill-IF-certain-cancer-specific-antigens-are-present, now you could instruct T cells to kill IF they sensed cancer cells AND they were in the right organ. Or IF they sensed cancer cells AND NOT other, healthy tissues. All of a sudden, T cells were much easier to customize and control.SynNotch formed the basis of a new company Lim and Roybal started in 2016 called Cell Design Labs.

The following year, it was bought by Gilead NASDAQ: GILD  and its immunotherapy subsidiary, Kite, for $567 million. Since then, Kite has begun recruiting for a clinical trial of its solid tumor CAR-T candidate, but it has not yet moved past Phase 1. At least one pharma firm seems interested in Arsenal Bio, a startup Roybal launched with another UCSF colleague, Alex Marson, in 2019. The 100-person company is focused on combining Roybal’s talents with Marson’s — which is making lots of DNA edits to T cells using CRISPR. (Both scientists also receive funding from Sean Parker’s immunotherapy moonshot.) Earlier this year, Bristol Meyers Squibb NYSE: BMY invested $70 million in Arsenal in exchange for the option to obtain an exclusive worldwide license to develop and commercialize any promising candidates the company discovers for fighting solid tumors.

Arsenal CEO Ken Drazan told STAT that the company is moving forward with a newer version of Roybal’s latest circuits as part of its partnership with BMS. He said the latest research out of UCSF is an important illustration of the slow but steady progress academia is making toward understanding why solid tumors don’t respond to currently available treatments. “That database of mechanisms and functions is growing every day,” he said. “That’s the fuel for a company like Arsenal, which is trying to make complex products that can address the complexity of these tumors.”  

Avalon GloboCare Corp. (NASDAQ: AVCO) is a clinical-stage, vertically integrated, leading CellTech bio-developer with  major prospects in immune effector cell therapy, exosome technology, as well as COVID-19 related diagnostics and therapeutics. Avalon 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.

In the first quarter of 2020, Avalon GloboCare (NASDAQ: AVCO) successfully completed a phase 1 first-in-human clinical study of AVA-001 in China for the treatment of relapsed refractory B cell acute lymphoblastic leukemia (R/R B-ALL). 90% of R/R B-ALL patients achieved complete remission with one dose and within one month of treatment, and then proceeded to a curative-intent allogeneic bone marrow transplant.  Also there was minimal and well tolerated side effects with little neurotoxicity or cytokine release. This paradigm of bridging CAR-T cell therapy to bone marrow transplant creates a new horizon with potentially ground breaking commercial application for patients with relapsed/refractory B-ALL and other hematologic cancers. 

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So far in 2021 Avalon GloboCare (NASDAQ:AVCO) has advanced there research platform substantially by expanding a Co-Development program with MIT using CRISPR based genome editing to combat cancer metastasis. They also announced a collaboration with the University of Pittsburgh Medical Center for development of their  FLASH-CAR™ RNA-based cellular therapies includes utilization of Avalon’s new Point-of-Care Modular Autonomous Processing System (PMAPsys™).  First FLASH-CAR™ candidate, AVA-011, on-track for clinical study in B-cell lymphoblastic leukemia and non-Hodgkin’s lymphoma patients. The FLASH-CAR™ technology modifies patients’ T-cells and natural killer (NK) cells using a ribonucleic acid (RNA)-based platform rather than a viral vector, and is being co-developed with the Company’s strategic partner, Arbele Limited. The adaptable FLASH-CAR™ platform can be used to create personalized cell therapies from a patient’s own cells, as well as “off-the-shelf” cell therapies from a universal donor. By avoiding viral vectors and complicated bio-processing procedures, the FLASH-CAR™ technology significantly reduces manufacturing costs and development times, resulting in more affordable and potentially breakthrough therapies for cancer patients. Avalon’s innovative FLASH-CAR™ technology can be used to generate universal cell therapies that may allow for widespread patient accessibility enabling broader commercial adoption compared to currently available CAR-T cell therapies. Avalon’s first FLASH-CAR™ platform candidate, AVA-011, targets both CD19 and CD22 tumor antigens on cancer cells and is in development for patients with relapsed/refractory B-cell lymphoblastic leukemia and non-Hodgkin’s lymphoma.  

“This is an important milestone in the clinical development and production of AVA-011 and other RNA-based FLASH-CAR™ candidates ahead of the start of our first-in-human clinical trials,” said David Jin, M.D., Ph.D., President and Chief Executive Officer of Avalon GloboCare. “We are excited about our partnership on the PMAPsys™ with UPMC, which we believe will help accelerate the path to bringing our own and third-party cell therapies to market. We are working diligently to fast-track development and commercialization of our cellular immune-oncology therapeutic products, while providing the highest quality and safety standards for our patients.”    

Avalaon GloboCare  (NASDAQ:AVCO) is  teaming up with some of the brightest minds in CAR-T and CRISP based technologies including  Dr. Yen-Michael Hsu, M.D., Ph.D., Director of the Immunologic Monitoring and Cellular Products Laboratory at the UPMC Hillman Cancer Center and  Dr. Shuguang Zhang at MIT’s Media La to rapidly develop potentially lifesaving technological advancements with major commercial applications. Recently some of the smartest money on Wall Street has been extremely bullish on this specific niche including Catherine Wood at ARK invest, in a recent interview she stated that her ARKG (ARK Genomic) ETF has the most potential upside over the next five years as the fund has been deploying billions to companies that produce or enable CRISPR, another Targeted Therapeutics.    Over the past few weeks microcap stocks have been under more than usual pressure resulting in Avalon GloboCare NASDAQ (AVCO) to be trading at their 52 week low at just around  S1.00 a share. I strongly believe Avalon’s pipe line along with a market cap of less than 100 million creates a highly asymmetric risk reward opportunity.  

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