A Message from BeiGene Regarding Our COVID-19
May 8, 2020
During the worldwide COVID-19 health crisis, our primary focus is 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 provides a strong foundation for BeiGene to partner with research institutions in the United States to explore the potential benefit of zanubrutinib, a BTK inhibitor discovered by BeiGene scientists, to treat patients with COVID-19 disease who have pulmonary distress. This is an important endeavor for BeiGene, for while we have been focused on developing oncology therapies to date, if zanubrutinib can help patients hospitalized for COVID-19-related pulmonary distress, we are committed to testing that hypothesis.
About the BGB-3111-219 Trial for Patients with COVID-19
We have received clearance from the U.S. FDA to initiate a new Phase 2 trial evaluating zanubrutinib for the treatment of patients with COVID-19 disease and 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.
Treating physicians in the United States who would like to request zanubrutinib on behalf of a patient with advanced COVID-19 and pulmonary distress should access BeiGene’s compassionate use program. This program is currently limited to patients in the United States.
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 U.S. Prescribing Information 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.
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 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 1,100 people in China, the United States, Europe, and Australia. Currently, we are conducting over 60 clinical trials globally, with 26 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, particularly in the first half of 2020 and possibly longer depending on the scope and duration of the disruption. While we have experienced decreased demand for our commercial products, we continue to execute on our clinical development, regulatory and commercialization goals and are working to minimize delays and disruptions.
BeiGene’s Alliance to Collaborate on a Novel Antibody Treatment for COVID-19
On April 29, 2020, BeiGene along with Atreca and IGM Biosciences announced plans to develop a treatment for COVID-19. In a 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. Given the urgency of the global COVID-19 pandemic, the parties have agreed to begin work immediately and plan to finalize financial details and other terms in the future.
The companies plan to utilize Atreca’s proprietary discovery platform to generate the sequences of antibodies made by particular B cells found in blood obtained from acutely infected COVID-19 patients. IGM’s technology platform will then be leveraged in an effort to develop and manufacture engineered IgM and IgA therapeutic antibodies from the identified sequences. BeiGene has agreed to provide global clinical development support by leveraging its more than 1,100-person global development team across China, the United States, Europe and Australia, including leading global regulatory interactions for any potential drug candidate that is developed.
BeiGene’s Additional Activities in the Fight Against COVID-19
We have launched a charitable initiative, called BeGenerous, which is currently 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 largely 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 legally permitted and 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 3,800+ employees in China, the United States, Australia, and Europe are committed to expediting the development of a diverse pipeline of novel therapeutics for cancer. We currently market two internally-discovered oncology products: BTK inhibitor BRUKINSA™ (zanubrutinib) in the United States, 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 trial of zanubrutinib in patients with COVID-19 who have pulmonary distress and the potential for zanubrutinib to help these patients, the rationale for zanubrutinib as a potential treatment 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 Atreca and IGM Biosciences on a potential treatment of 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 zanubrutinib may not receive regulatory approval for the treatment of COVID-19; zanubrutinib is an investigational agent that has not been approved by the FDA, and it has not been demonstrated to be safe or effective, for the treatment of COVID-19; the possibility of unfavorable results from the clinical trial of zanubrutinib for COVID-19 and the possibility that BeiGene may be unable to complete this trial 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 collaboration 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 annual report on Form 10-K, 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.