A Message from BeiGene Regarding Our COVID-19
September 14, 2020
During the worldwide COVID-19 health crisis, our primary focus has been on keeping BeiGene colleagues and their families safe, upholding our commitments to patients, and providing assistance and materials to doctors and hospitals on the frontline.
In addition, based on a developing understanding of COVID-19 disease, we quickly realized that our mission to create impactful medicines based on sound scientific rationale provided a strong foundation for BeiGene to explore other ways we could help. Our approach to this has been both broad and strategic, forming important alliances where we see scientific advances, as well as collaborating with research institutions in the United States to explore the potential benefit of zanubrutinib, our BTK inhibitor, to treat patients with COVID-19-related pulmonary distress.
These are important endeavors for BeiGene, for while we have been focused on developing oncology therapies to date, if we can help patients with COVID-19 or prevent it from spreading throughout our communities, we are committed to devoting resources and our expertise in clinical development to do so.
BeiGene's Exclusive License Agreement with Singlomics for Neutralizing COVID-19 Antibodies
On August 27, 2020, BeiGene and Singlomics Biopharmaceuticals announced an exclusive license agreement for BeiGene to develop, manufacture, and commercialize Singlomics’s investigational anti-SARS-Cov-2 antibodies globally outside of Greater China.
Under the scientific leadership of the Singlomics’ co-founder and renowned biophysical chemist Sunney Xie, Ph.D., Singlomics was able to identify SARS-Cov-2 neutralizing antibody drug candidates, including DXP-593 and DXP-604, by utilizing high-throughput single-cell sequencing of convalescent blood samples from recovered patients with COVID-19. Both DXP-593 and DXP-604 have exhibited strong neutralization potency in preclinical testing.
A Phase 1 randomized, double-bind, and placebo-controlled clinical trial started enrolling up to 30 healthy subjects in Australia in September 2020, and a Phase 1/2 multinational trial in patients with mild to moderate COVID-19 is expected to begin enrollment by early October.
About the BGB-3111-219 Trial of Zanubrutinib for Patients with COVID-19
We have initiated patient enrollment in a Phase 2 trial in the U.S. evaluating zanubrutinib for the treatment of patients with COVID-19-related pulmonary distress (NCT04382586).
The trial is designed to enroll approximately 42 patients with COVID-19 disease who either require supplemental oxygen or mechanical ventilation. The principal investigator, Steven P. Treon, M.D., Ph.D, of the Dana Farber Cancer Institute in Boston, along with BeiGene clinicians and scientists, designed a trial to assess quickly whether treatment with zanubrutinib can help hospitalized patients with COVID-19-related pulmonary distress. Patients will be randomized to receive oral zanubrutinib at 320 mg once daily for 28 days plus supportive care, or placebo plus supportive care. An additional cohort of four to 10 patients on mechanical ventilation will all receive zanubrutinib plus supportive care. The trial’s primary endpoint is the respiratory failure-free survival rate at day 28 in the randomized cohort.
Currently, there is no evidence on the safety or efficacy of zanubrutinib in the clinical treatment of COVID-19, and zanubrutinib is not approved for this use. Please view the U.S. Prescribing Information for BRUKINSA® at www.brukinsa.com.
Rationale for Zanubrutinib as a Potential Treatment for COVID-19
Emerging evidence suggests that one of the most serious medical issues faced by patients with COVID-19 disease is a phenomenon called “cytokine storm,” which is an overproduction of immune-activating compounds, called cytokines, that leads to a surge of activated immune cells in the lungs. The resulting lung inflammation and fluid buildup can cause acute respiratory distress syndrome (ARDS) and sometimes secondary bacterial pneumonia. These conditions are believed to increase a patient’s risk of death.
Bruton’s tyrosine kinase (BTK) inhibitors, such as zanubrutinib, block the BTK protein that is essential to the signaling of B-cells in the human immune system. Evidence from preclinical and clinical studies of BTK inhibitors suggests that they can reduce inflammatory cytokines by blocking the cytokine production that can be caused by enhanced BTK signaling.
We believe that, based on its mechanism of action and established safety profile in clinical studies to date, zanubrutinib may be effective as a small molecule inhibitor to treat the cytokine storm phenomena.
BeiGene's Alliance to Collaborate on a Novel Antibody Treatment for COVID-19
On April 29, 2020, BeiGene, Atreca, Inc. and IGM Biosciences announced plans to develop a treatment for COVID-19. In the spirit of scientific collaboration and cooperation, we are hopeful that our combined technology and expertise might help the companies discover, develop, and manufacture novel IgM and IgA antibodies targeting SARS-CoV-2 for the potential treatment of COVID-19.
The Impact of COVID-19 on Our Supply Chain
We are monitoring the COVID-19 pandemic closely and, based on current inventory levels, do not currently foresee a disruption in our ability to supply BRUKINSA (zanubrutinib) to our patients in the United States, where the drug is approved for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. We also do not currently foresee a disruption of BRUKINSA supply in China where the drug is approved as a treatment for MCL in adult patients who have received at least one prior therapy and the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who have received at least one prior therapy. We are also coordinating with authorities, hospitals, logistics providers and other firms in our supply chain to ensure the uninterrupted supply of our investigational medicines to patients on our clinical trials globally and our approved medicines to patients in China who need them.
The Impact of COVID-19 on Our Clinical Trials
We have built an integrated global development team of more than 1,300 people in China, the United States, Europe, and Australia. Currently, we are conducting over 70 clinical trials globally, with 27 potentially registration-enabling trials ongoing.
While we conduct clinical trials globally, we have a high concentration of clinical trial activity in China. Since the beginning of the year, we have adopted a variety of methods to minimize the impact of COVID-19 on our studies in China. We have adapted these methods to other geographies as the pandemic has spread to Europe, the United States, and other regions where we conduct trials. Our experience in China has allowed us to identify aspects of clinical trials that can be optimized so that patients avoid missing treatments and assessments. We are cautiously optimistic about how these efforts are going.
The FDA and other international regulatory agencies have also issued guidance on clinical trial conduct during the COVID-19 outbreak. This guidance, along with our experience, has been helpful as we work with our investigational sites to implement alternate methods where needed. We currently believe that the quality of data coming from our clinical trials during the COVID-19 outbreak will be unaffected.
The Impact of COVID-19 on Our Business
We expect that the worldwide health crisis of COVID-19 will continue to have a negative impact on our operations globally, including clinical trial recruitment and participation, regulatory interactions and inspections, and commercial revenue. While we have experienced decreased demand for our commercial products, we are working to minimize delays and disruptions and continue to execute on our clinical development, regulatory and commercialization goals.
BeiGene’s Additional Activities in the Fight Against COVID-19
We launched a charitable initiative, called BeGenerous, coordinated by our COVID-19 task force, to procure and donate personal protective equipment (PPE) to hospitals around the world and provide other charitable support. Initially, our team in China, with the assistance of our global team, secured and delivered much-needed PPE and supplies to doctors and hospitals on the frontlines in Wuhan and Hubei Province. We were among the first companies to do this. With the impact of the COVID-19 pandemic being felt outside of China, we have also helped to secure PPE for distribution to hospitals in the United States, while our employees globally, including in Europe and Australia, are engaged in active donations of medical supplies and other support in their communities.
For the safety of our employees, we were early in closing our offices in China and then in the United States and Europe as the COVID-19 pandemic spread. We were also early in suspending domestic and international travel, changing all in-person meetings to virtual meetings, and temporarily suspending all in-person field activities. Our employees in China have returned to the office, following required and recommended precautions such as wearing masks, temperature screening and social distancing, and we are monitoring the situation closely in the United States and Europe as we make plans for our employees to return to the office when it is deemed safe.
BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. Our 4,200+ employees in China, the United States, Australia, and Europe are committed to expediting the development of a diverse pipeline of novel therapeutics. We currently market two internally discovered oncology products: BTK inhibitor BRUKINSA® (zanubrutinib) in the United States and China, and anti-PD-1 antibody tislelizumab in China. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company, and EUSA Pharma.
For more information please contact us at beigene.com/contact-information.
This message contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the conduct of our clinical trials of SARS-Cov-2 neutralizing antibody drug candidates licensed from Singlomics and of zanubrutinib in patients with COVID-19 who have pulmonary distress and the potential for these drug candidates to help these patients, the rationale for the licensed SARS-Cov-2 neutralizing antibody drug candidates and zanubrutinib as potential treatments for COVID-19 disease, the impact of the COVID-19 pandemic on our supply chain, clinical trials and other aspects of our business, our plans to collaborate with Singlomics and with Atreca and IGM Biosciences on potential treatments for COVID-19, and our ongoing efforts in response to the COVID-19 pandemic. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the possibility that the in-licensed SARS-Cov-2 neutralizing antibody drug candidates and/or zanubrutinib may not receive regulatory approval for the treatment of COVID-19; the in-licensed SARS-Cov-2 neutralizing antibody drug candidates and zanubrutinib are investigational agents that have not been approved by the FDA or other regulatory agencies and have not been demonstrated to be safe or effective for the treatment of COVID-19; the possibility of unfavorable results from the clinical trials of the in-licensed SARS-Cov-2 neutralizing antibody drug candidates and/or zanubrutinib for COVID-19 and the possibility that BeiGene may be unable to complete these trials in the currently anticipated timeline or at all; the ability of Atreca, BeiGene and IGM to discover, develop and manufacture novel IgM or IgA antibodies targeting SARS-CoV-2 for the treatment of COVID-19; the risk that Atreca, BeiGene or IGM decide not to pursue the collaboration or that the parties are unable to agree to further terms and arrangements for the collaboration in the future; the risk that the potential benefits of the collaborations with Singlomics and with Atreca and IGM do not materialize or do not outweigh the costs; and the impact of the COVID-19 pandemic on BeiGene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.