How we are responding to COVID-19
A Letter from our President & CEO, Howard Robin (updated May 7, 2020)
During this unprecedented time, Nektar remains committed to advancing its mission of bringing forth novel therapies for the treatment of cancer and autoimmune disorders. We continue to closely monitor the evolving situation with COVID-19 to prepare for and minimize the potential impact this pandemic may have on our business.
As we work together to navigate the current environment, we have three main priorities:
First, to protect the health of our employees while continuing our essential operations on-site to advance our research and development, such as laboratory and manufacturing activities
We believe we all play an important role in slowing the community spread of COVID-19, and, as such, we are closely adhering to all applicable guidelines with respect to the operation of our facilities and reinforcing shelter-in-place orders. Essential operations in research, medical and manufacturing are continuing in accordance with the permissions granted under government ordinances.
At this time, we do not anticipate any supply interruptions for manufacturing, including our preparations for scale-up of commercial supply of bempegaldesleukin, which are underway. The company has sufficient quantities of bempegaldesleukin, NKTR-262, NKTR-255 and NKTR-358 to supply the ongoing clinical programs for these investigational medicines. We and our manufacturing partners are continuing to regularly assess the situation.
Second, to ensure that each of our trial investigators and their teams can continue to provide superior care and uninterrupted access to study treatment to patients fighting cancer in our clinical studies
Nektar has numerous clinical trials underway in cancer treatment facilities across the globe that are continuing to proceed. Over the past several months, we deployed a strategy to allow continued enrollment and new study site initiations at facilities that have demonstrated operational readiness and are equipped to provide superior care and uninterrupted access to study treatment and patient services.
For all ongoing clinical trials, we are working closely with clinical trial sites to understand their needs during this time. We are utilizing remote monitoring when possible to oversee study conduct. We have adopted processes to allow for telemedicine and closer access to patient care where and when appropriate so we can continue all data collection processes and support patient safety.
Third, to ensure that the conduct of our clinical trials is minimally impacted, and the integrity and quality of data being collected from these studies are maintained
We continue to monitor and support patients by leveraging alternative methods for maintaining clinical trial integrity, and to properly record patient event data that may be related to the COVID-19 pandemic, incorporating recent direction and flexibility provided by regulatory authorities, including the United States Food and Drug Administration in its March 18, 2020 Guidance (updated April 16, 2020) entitled “FDA Guidance on Conduct of Clinical Trials of Medicinal Products during COVID-19 Public Health Emergency.” This Guidance is continually being updated by FDA and updates can be found on the FDA’s website at www.fda.gov. In addition, we may refer to Guidance documents from other regulatory agencies, such as, for example, the European Medicines Agency’s “Implications of coronavirus disease (COVID-19) on methodological aspect of ongoing clinical trials” found on www.ema.europa.eu, which are also continually being updated.
The majority of Nektar-run clinical studies in oncology have not experienced any significant delays. We caution that the evolving landscape could impact these statements and could still delay late-stage studies or enrollment of new patients into clinical trials in the future. We currently believe that we could experience delays of approximately three months with respect to previously-provided timelines for earlier stage Nektar-run studies, such as the PROPEL study, where the initiation of planned new investigator sites in Europe was delayed due to the COVID-19 pandemic.
For Nektar’s pharmaceutical partners, management practices around ongoing and planned clinical trial activities have varied during the COVID-19 situation. Based upon our current assessment of activities of our pharmaceutical partners, at this time, we currently expect adjustments of timelines for projected study endpoints, study enrollment rate and study starts of between three to six months. However, this is subject to change as the situation is evolving and will depend upon how long COVID-19 precautionary measures remain in place.
Lastly, to supporting our local healthcare workers
Our team members are continuing to work with our local communities to facilitate donations of personal protective equipment, such as masks and gloves, to healthcare workers. In the San Francisco Bay Area, initial donations have been made to UCSF Medical Center, Kaiser Permanente Santa Clara Medical Center, SF Department of Public Health and UCSF Bio Hub.
Nektar and our partners are working hard to appropriately adapt our business practices and our response, while at the same time leading and operating our business effectively. During this dynamic situation, the safety and well-being of our fellow employees, and the patients and healthcare providers in our clinical trial programs, remain of first and foremost importance to us. We are committed to complying with guidance from government and public health officials and adapting to stop the spread of COVID-19.