SRI International, an independent nonprofit research institute, has been awarded a $4.95 million contract, with options to fund up to $21 million, from the National Institute of Allergy and Infectious Diseases (NIAID) to develop drugs to increase the nation’s therapeutic arsenal against new or existing viral pathogens.
The funds are part of the US government’s Antiviral Program for Pandemics (APP), allocated across multiple virus families with pandemic potential, to support pre-pandemic therapeutic development. The APP includes investments in new therapeutics to provide healthcare providers and disease scientists with the tools required to combat emerging diseases and prevent widespread transmission at the early stages of an outbreak. But even before the APP, the federal government began contracting out the important work of vetting promising therapeutic drugs and conducting clinical trials.
In the last 100 years, many epidemic- or pandemic-level viral outbreaks have occurred, with many in the last 20 years, including swine flu (Influenza H1N1), Chikungunya, Ebola, Zika virus, Mpox, MERS, and SARS. The uptick in emerging infections illustrates the increasing probability of serious outbreaks due in part to population growth, climate change, habitat loss and increased travel.
“Developing drug therapies for the next pandemic isn’t easy or particularly profitable, which leaves the bulk of this type of drug development up to the federal government,” said acting SRI Biosciences division president Jon Mirsalis, who also serves as the principal investigator of the NIAID-funded program.
Prioritizing promising drugs
SRI received its first NIAID contract for anti-infective drugs in 1991 to study HIV therapies, which led to additional contracts that targeted subsequent outbreaks or threats, including anthrax, Ebola, drug-resistant bacteria, and hepatitis C. In the over three decades, SRI has assisted in advancing over 50 therapies from basic research into clinical trials by leveraging its capabilities to perform all of the pharmacokinetic and safety studies required to file an Investigational New Drug application (IND) with the FDA.
While SRI has much experience in the field of infectious disease drug development, all government contracts are awarded from a competitive pool of contractors in specific task areas, including medicinal chemistry, manufacturing, pharmacology, and toxicology. SRI’s pioneering work in drug development and proven track record of success has helped secured its leadership role in this field, with over $200 million awarded for work related to advancing anti-infective drugs, and hundreds of millions in other therapeutic areas. SRI has contributed to the development of thousands of drugs to date; approximately 200 have been tested in the clinical trial process, and over 20 have obtained market approval.
Learning from COVID-19
COVID-19 highlighted the power of modern science and collaboration at institutes like SRI. In addition to the recent win for development of new antiviral drugs, SRI has active drug discovery, development, and testing programs against a variety of pathogens including COVID-19, influenza, and drug-resistant bacteria. The recent NIAID award fits within a broader program within SRI to discover and develop new anti-infective therapeutics and vaccines.
“SRI’s capabilities to take antiviral agents from development through testing using our biocontainment research facilities has positioned us well to support antiviral drug discovery,” said Mary Lanier, SRI Biosciences Division’s Director of Immunology and Virology, who is working with a number of commercial organizations on the development of antiviral drugs against SARS-CoV-2 and other viral pathogens.
The APP was developed to build on the country’s response to and preparedness for future viral pandemics after identifying deficiencies during the COVID-19 pandemic. Ideally, with any future unknown disease, the pathogen will be diagnosed within hours to days and classes of drugs will be available to treat the disease and stop or mitigate the pandemic threat during the early stages. “By making these investments now, we should be in a better position for the next emerging pathogen,” said Mirsalis.
The work will be performed under contract HHSN272201800001I, Task Order 75N93022F00011.