Today biopharmaceuticals have been hit hard. First, the third phase of clinical trial Exp3 of Lilly's powdered protein antibody Solanezumab did not reach the end of the trial, and Lilly announced that it would abandon the application. Then, in the ROCKET test of Juno's CAR-T drug JCAR015, two patients died of cerebral edema, and Juno consciously suspended the test. Affected by this, Lilly's stock fell 10.5%, Juno fell 24.5%.
Drug source analysis
ROCKET has caused three cases of cerebral edema deaths in July this year and was stopped by the FDA, when Juno believed that the dose of fludarabine, a pretreatment chemotherapy drug, was too high. After Juno agreed to stop using fludarabine, the FDA responded to this clinical trial in just a few days. Today, this result shows that fludarabine is not a source of toxicity, at least not the only source, and the FDA's rapid response has been questioned. The same drugs that Juno's other CAR-T and Kite are developing have not found such serious side effects, which may be due to small differences in different CAR-T structures, or that the samples are not large enough now, and toxicity events have not yet occurred. Another CAR-T pioneer, Novartis, disbanded the cell therapy division this year and laid off 120 people. Although CAR-T shows an amazing response rate, the persistence is not as good as expected. Coupled with price, production, and safety issues, the once promising CAR-T is now facing a crisis of confidence.
The competition for new drugs is now very cruel. The previous generation of subversive technology antibody drugs did not have many competitors in the early days, and even after the market, no one did me-too tracking drugs. However, from the very beginning, CAR-T has participated in many companies and the competition is fierce. Manufacturers undoubtedly want to be the first to go public, but this is a very dangerous frontier, balancing speed and risk requires a high skill. In addition, although the manufacturer has invested capital and technology, the patient is also an indispensable part, and the patient's life cannot be calculated with money. So don't forget the limitations of technology and the responsibility to patients.
Although AD doesn't sound as scary as ALL, I have been to several advanced AD patients. It was not the biggest disaster when she died of cancer at a young age. It was really that bad. AD is a much larger disease than ALL, and the number of patients is rapidly increasing as the population ages. Now AD has only a few symptom-relieving drugs, and there is no drug that changes the course of the disease. Improving symptoms is like a TV is broken. Sometimes you can watch it from a certain angle for a few days, so you don't need any knowledge of the internal structure of the TV. Changing the disease process is like fixing a TV failure. This requires knowing how the TV works.
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