New directorate expands serology capabilities

As the Frederick National Laboratory for Cancer Research (FNL) expands its serology efforts in response to the COVID-19 pandemic, the biomedical research institution formed a new section dedicated to those efforts and the evaluation and standardization of immune responses to vaccines, infections and cancer.

Establishment of the Vaccine, Immunity, and Cancer Directorate recognizes the growing prominence of serological science. Directorate lead is Ligia Pinto, Ph.D., who in 2017 helped launch the FNL program studying immune responses to human papillomavirus (HPV) infection and vaccines in the context of clinical and epidemiological studies. Her team also leads efforts in serology standardization and preclinical studies of other candidate cancer preventive vaccines. Now, Pinto’s work will have a broader reach with additional teams and projects in serology, infections and cancer, including a new unit dedicated to the COVID-19 pandemic response.

“It’s very exciting,” Pinto said. “We’re thrilled to use our expertise to inform and help make public health changes.”

Organizational restructuring

“The new directorate is an amazing alignment of Dr. Pinto’s work on HPV, this current, horrible pandemic and my long-standing interest in standards,” said Chief Science Officer Leonard Freedman, Ph.D. “I’m excited to be supporting it and to be working with Dr. Pinto on it. It’s a textbook example of how to take our expertise in one area and pivot quickly and significantly into another.”

The new directorate includes the Cancer Immunoprevention Laboratory as well as the Serology Laboratory, which includes two main teams. One team is working on HPV serology and immunology, and another is dedicated to COVID-19 serological sciences.

This COVID-19 unit is the hub for the National Cancer Institute (NCI) Serological Sciences Network, the largest coordinated effort to quickly increase the nation’s antibody testing capacity and to better understand the immune response to SARS-CoV-2. The network’s coordinating center, operated by FNL, will also fall under this new directorate.

COVID-19 pandemic escalated needs for serology

While serology isn’t a new concept, Pinto said the COVID-19 pandemic increased demands for serology research to better understand viral immune responses and appropriately develop and validate antibody tests.

“Serology is a very old field,” Pinto said. “It takes on another dimension at this moment because of being a critical tool in the world’s response to a pandemic.”

In March 2020, Pinto and FNL’s HPV Serology Laboratory began working with the NCI and the U.S. Food and Drug Administration (FDA) to evaluate the performance of COVID-19 antibody tests. This analysis provided data to FDA that helped shape decisions for approval or rejection of commercial tests.

By the summer, the NCI announced its plans for an initiative that would bring together biomedical institutions focused on basic research and enhancing capacity for antibody research and testing around the nation. This became the Serological Sciences Network. Pinto and her team worked closely with the NCI to implement this large initiative and lead the efforts in the standardization of SARS-Cov-2 serology.

A key achievement by the NCI and the FNL Serology Laboratory is the production of a Human SARS-CoV-2 Serology Standard, which was released in January to be used for calibration purposes by laboratories conducting SARS-CoV-2 serology testing.

“Both the serology testing evaluation program and the standard production were due to a strong collaboration among different government agencies and academic organizations,” Pinto said.  “These type of strong collaborations and partnerships are key to making rapid advances in science and health.”

“Serology has emerged as such an important discipline, especially now,” Freedman said. “Certainly, we’re going to be faced with another pandemic. We can take what we learn and what we establish as standards, and other approaches to serological studies of COVID-19. We’ll be in a stronger position for the next challenge.”

History of serology expertise

Pinto joined FNL in 2001 after more than a decade of research on HIV and HIV vaccines. She established the HPV Immunology Laboratory, which evaluates immune responses to HPV vaccines and has played a substantial role in characterizing the immunogenicity of currently licensed HPV vaccines that are given worldwide. The work done by the HPV Immunology Laboratory gave rise to the establishment of two additional FNL-based laboratories: The HPV Serology Laboratory and the Cancer Immunoprevention Laboratory.

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The HPV Serology Laboratory was established in 2017 to lead an international standardization initiative, sponsored by the NCI and The Bill & Melinda Gates Foundation. The Cancer Immunoprevention Laboratory evaluates and develops new immunoprevention strategies and novel assays for biomarker research.

Pinto said she has always loved science that really affected the world, and her passion keeps her going even as her schedule gets busier and busier.

“It’s definitely a dream come true to work together with so many partners and have our collective science impact public health, make changes in the world and help people,” Pinto said.

Before Freedman joined FNL in 2018, he remembers picking up the phone one day and hearing Pinto’s voice on the other end. At the time, Freedman headed the Global Biological Standards Institute, a nonprofit dedicated to advancing life science standards and best practices through policy initiatives, thought leadership, and education. Freedman said Pinto was eager to discuss her work with him and their shared interest in standards and reproducibility.

“One of the things that struck me about Dr. Pinto is that she was so passionate about the importance of serology and serological standards as it related to the HPV vaccine,” Freedman said. “To be honest, I had not previously thought about applying our work on standards to serology, because serology was a bit of niche area. I now see it every day in the work the Serological Sciences Network and the FNL team does with COVID-19, with global ramifications.”

As her team expands, Pinto said she is really grateful to be surrounded by others who believe in the mission and share her passion.

“I just have the best team in the world,” she said. “There’s lots of work, lots of challenges, but it’s extremely exciting and together we hope to help to make this a healthier world.”