According to STAT article “Amgen’s NASDAQ:AMGN KRAS cancer drug had a bad week, but worry about pricing, not safety” Investors do not like surprises with negative overtones, so they reacted badly when Amgen announced last Tuesday that it was conducting a new study to compare a 240 mg dose of its KRAS-targeted lung cancer pill, sotorasib, against the 960 mg dose that is now under review by the Food and Drug Administration. Amgen’s stock price fell 6% last week, the most among all the large-cap drug makers. The reaction was mostly interpreted as concern about the drug’s safety. But the real issue and risk for sotorasib could be its price.
Although the company did a poor job answering questions last week — Why suddenly study a lower dose of sotorasib if the higher dose is fine? Did the FDA discover something bad in sotorasib’s safety profile during its review? — it insisted there was nothing wrong with the 960 mg dose of sotorasib. Amgen also said it was the FDA that proposed looking at the efficacy and safety of a lower dose as a “post-marketing requirement” — meaning, presumably, after the higher dose was already approved.
Why? Because analyses of drug concentrations within patients conducted by the FDA during its review suggested a lower dose of sotorasib might be equally effective and better tolerated than a higher dose. Importantly, the FDA has not uncovered a previously unreported toxicity that makes the 960 mg dose unprovable, said the source, who requested anonymity because they were not authorized to speak on behalf of the company.
Mark Ratain, an oncologist at the University of Chicago Medicine and an expert in the “dose optimization” of cancer drugs, said determining the lowest effective dose of sotorasib should be a priority for the FDA. “It’s a standard principle of drug development that you don’t give more drug than you need to maximize the benefit,” Ratain told STAT. “I haven’t spoken to the FDA or Amgen, but I suspect the FDA made Amgen do this because the agency is very concerned about oral drug adherence. The FDA wants to get rid of any unnecessary side effects.”
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.