BeiGene, a China-based biotechnology company, is launching a U.S. trial for Brukinsa in later-stage COVID-19 patients, another sign of the growing consensus among blood cancer doctors and researchers that BTK inhibitor drugs might be able to rescue patients from ventilators. BeiGene has submitted a phase-2 randomized trial to the Food and Drug Administration that plans to enroll 42 U.S. patients. The drug will be given mostly to hospitalized COVID-19 patients requiring oxygen who are not on ventilators and six patients who are receiving mechanical ventilation. The company should get results in two to three months. Known as a Bruton?s tyrosine kinase (BTK) inhibitor, Brukinsa, which is also known as zanubrutinib, was approved in the U.S. for patients with mantle cell lymphoma in November. It was the first FDA approval of a Chinese cancer treatment and was secured mostly on Chinese data. BeiGene developed Brukinsa to compete with AbbVie and Johnson & Johnson?s top-selling Imbruvica, which generated $8.1 billion of 2019 revenues, and AstraZeneca?s Calquence. But in recent weeks blood cancer researchers started to believe BTK inhibitors could help tame the out-of-control cytokine storm immune response to the virus that has killed COVID-19 patients by damaging their lungs. On Monday,?Forbes?reported?that British drug giant AstraZenca had launched a 428-patient trial of Calquence after the federal government?s National Cancer Institute and McKesson?s U.S. Oncology gave the drug to a small number of hospitalized COVID-19 patients who showed a clinical benefit. Both NCI and AstraZeneca emphasized the need for clinical trials to determine the effectiveness of Calquence. NCI said ?it is premature to conclude that [Calquence] will provide benefit across patients with advanced lung disease due to the very early and limited use of this agent in COVID-19 at this time.? Steven Treon, director of the Bing Center for Waldenstrom?s Macroglobulinemia at Boston?s Dana-Farber Cancer Institute, said his institution also had some anecdotal experiences involving six COVID-19 patients with Waldenstrom?s lymphoma who were on Imbruvica. Five of those patients sailed through their COVID-19 disease with no shortness of breath or hypoxia, Treon said. Another patient who was on a reduced dose of Imbruvica stopped taking the drug and wound up on a ventilator. While on the ventilator, the patient was given full doses of Imbruvica, which was mixed with water, through a nasogastric tube. Within two days, the patient was off the ventilator and then went home. Treon approached BeiGene about starting a Brukinsa trial earlier this month and within four days the company had completed a protocol. In addition to some preclinical evidence, Treon had come to believe that his work on the toll receptor pathway in Waldestrom?s might be relevant because this class of proteins, which is connected to BTK, can trigger the cytokine storm. The idea is to reduce the immune system response by blocking BTK. Treon, who has high hopes for the anti-inflammatory benefits of BTK inhibitors in COVID-19 patients, will be the principal investor of the study that will include other sites. For the time being, the company has decided not to pursue COVID-19 patients in China because the disease is under control there at this time. ?If these trials show what we expect them to show, these drugs are going to be big game changers?the concepts have to be proven in a randomized prospective study,? says Treon. ?I am a hardcore physician-scientist, I don?t like taking things off the shelf and trying them. This one has very strong rationale and you see elegant animal modeling that supports this approach.?