According to STAT Article “ The long wait for Cel-Sci to finally admit its cancer drug doesn’t work” Eventually, Cel-Sci AX:CVM will have to disclose the results of its Phase 3 cancer clinical trial. When that happens is anyone’s guess.Tuesday marked one year since the small biotech announced the completion of the study, which is investigating an immune-boosting drug called Multikine in patients with head and neck cancer. There is no set timeline for how long it takes to analyze and read out results from a clinical trial, but generally, six weeks to two months is a good rule; allowing three or four months to crunch the numbers is being generous. But one year?
No legitimate reason exists for Cel-Sci to be taking this long, even accounting for Covid. The simple truth is Cel-Sci is trying to bury Multikine’s negative results, as it did previously when independent monitors tried to shut the study down twice, or when the FDA halted the study citing an “unreasonable and significant risk of illness or injury to human subjects.” Cel-Sci was only allowed to restart the study after agreeing not to enroll or treat any additional patients. Multikine hasn’t been injected into a patient with cancer for five years. It knows the drug failed and is doing everything in its power to delay dissemination of the bad news from the final analysis. But publicly, Cel-Sci continues to tell investors all is well.
“CEL-SCI is blinded to the study data,” Cel-Sci CEO Geert Kersten wrote in a letter to shareholders last January. “There is a process to getting the results, and we are not part of it, so we have no choice but to wait.” In the months since, he has repeatedly reiterated that argument through his Twitter account. That’s called plausible deniability. It’s possibly true that Kersten and his underlings do not possess the study data from the final analysis, but only because they’re not asking to see those data. Cel-Sci has spent millions of dollars with two contract research firms that conducted the study and are now, presumably, analyzing the data. It’s absurd to believe Kersten’s assertion that the company has no control over the analysis process, as if the CROs are dictating the terms of the contract when Cel-Sci writes the checks.
If Cel-Sci was truly motivated to disclose the Multikine data, it would have revealed the results months ago. But here we are, one year and counting with nothing but excuses obscuring a failed cancer drug. The push-out won’t be interminable, but could it go another three month? Six months? Might I write a similar column on the one-year anniversary of this one? It’s very possible! Cel-Sci’s shareholder base consists of retail investors (most of whom treat the stock like a cult), index funds, and friends of Kersten. No one with any legitimacy on Wall Street is pressuring Cel-Sci to admit Multikine’s failure. The Securities and Exchange Commission has allowed bad behavior by biotech companies to fester for years without a hint of enforcement oversight. Don’t expect those regulators to step up. Likewise, the Food and Drug Administration hides behind its archaic rules that render it mute until, or unless, a drug maker actually files a drug for review.
So, Cel-Sci is pretty much in the clear to do what it wants, which lately means using its official Twitter account to solicit a Reddit-induced short squeeze. Add “obsessed with short sellers” to the list of Cel-Sci red flags.
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.
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.