RESEARCH TRIANGLE PARK – Seqirus hopes to raise the bar on flu prevention with the accelerated development of its next-generation influenza vaccine technology, called self-amplifying messenger RNA – or sa-mRNA.

The Summit, New Jersey-based company is one of the largest flu vaccine manufacturers in the world. It operates a massive manufacturing facility in Holly Springs, about 24 miles south of Research Triangle Park, that produces several types of flu vaccines using egg, cell and adjuvant (enhanced immune response) technologies.

The company currently is developing a number of sa-mRNA-based vaccine candidates that it said are showing promise in preclinical trials. So it plans to speed up the process by creating a dedicated sa-mRNA program, with clinical trials targeted for both seasonal and pandemic flu vaccine candidates in the second half of next year.

The COVID-19 pandemic has brought messenger RNA (mRNA) into prominence. Pfizer and Moderna are the first to gain approval to use the new technology broadly in their coronavirus vaccines. Seqirus wants to take the process one step further.

Seqirus facility in Holly Springs. — Seqirus photos

MRNA vaccines help the body protect itself against infectious diseases by teaching cells to make a protein that triggers an immune response. They also leave a blueprint to recognize and fight future infection. Self-amplifying mRNA – the next generation of the technology – also instructs the body to replicate mRNA, which increases the amount of protein made. And this enables manufacturers to potentially develop more-effective, smaller-dosage vaccines that cause fewer adverse reactions.

Seqirus said its preclinical research has shown the potential for sa-mRNA technology to create a stronger cellular and antibody response at the same dose levels as mRNA. It also is exploring the potential to target sa-mRNA vaccines at other diseases.

Roberta Duncan to lead sa-mRNA program

Roberta Duncan.
Roberta Duncan.

“Seqirus has been researching sa-mRNA as a viable influenza vaccine technology for a number of years and is now forging ahead into clinical trials to ensure we build the best possible technology platform for both seasonal influenza and pandemic response, more broadly,” said company General Manager Stephen Marlow. “As part of Seqirus’ investment in this next-generation sa-mRNA technology, I’m proud to announce the appointment of Roberta Duncan in the newly created role of vice president, mRNA program lead.”

Duncan joined Seqirus in 2017 as head of Business Operations, Shared Services and Clinical Compliance. She was promoted to executive director of R&D Portfolio and Program Management & Business Operations, Shared Services in 2019. In that role, she was responsible for aligning the R&D portfolio to meet the company’s strategic objectives.

The flu is nothing to sneeze at

Seqirus is the lone global company focused solely on influenza, which as most flu sufferers can attest, is nothing to sneeze at. The seasonal respiratory disease can cause severe illness and even life-threatening complications in some people.

The U.S. Centers for Disease Control and Prevention (CDC) estimated that there were about 405,000 influenza-related hospitalizations and 6,300 deaths in the U.S. during 2019-2020. The flu season normally begins in late fall and peaks in mid- to late winter.

The CDC recommends that most people six months old and older get vaccinated by the end of October. Seqirus said it will supply up to 60 million doses of serum to meet the demand this year.

Pandemic flu is more unpredictable. And the risks are generally greater because there is likely to be little or no pre-existing immunity to the virus. Four influenza pandemics have occurred over the past century, with the 1918 outbreak the most severe in recent history. It is estimated to have killed up to 50 million people worldwide. By comparison, the COVID-19 pandemic has resulted in somewhere between four and seven million-plus deaths globally to date.

“As the industry leader in influenza vaccines, we recognize the important role that we must play to develop this platform, today and for years to come,” Duncan said. “It’s an exciting time for the industry and for Seqirus, as we continue actively pursuing technological advances to improve influenza protection and help safeguard our communities around the world against this potentially serious virus.”

Seqirus in North Carolina

Seqirus was formed in 2015 after its Australian parent, CSL Ltd., purchased the former Novartis full-scale culture vaccine-manufacturing site in Holly Springs along with the related technology. The $1 billion-plus facility was originally designed to increase production of flu shots in response to outbreaks or a pandemic.

The North Carolina Biotechnology Center was actively involved in recruiting the manufacturing center, which is located on 185 acres and encompasses nearly a half million square feet – an area the size of about 10 football fields.

Seqirus has close to 900 employees at the Holly Springs complex and 3,300 worldwide, with a commercial presence in 20 countries. It also has production facilities in the United Kingdom and Australia.

CSL Ltd. is headquartered in Melbourne, Australia, and has a workforce of close to 27,000. CSL also operates CSL Behring, a global biotechnology company that focuses on rare diseases.