BeiGene Launching Brukinsa Trial In Later-Stage COVID-19 Patients

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BeiGene Launching Brukinsa Trial In Later-Stage COVID-19 Patients
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BeiGene, a China-based biotechnology company, is launching a U.S. trial for Brukinsa in later-stage COVID-19 patients

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.

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.

“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.”

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