Emergent BioSolutions today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, has awarded the company a research and development option worth $41.9 million to its existing contract to further the development and scale-up of its monoclonal antibody treatment for Ebola virus infection.

The 10-year contract for the drug known as Ebanga (ansuvimab-zykl or mAb114) was initially awarded by BARDA in August 2023. 

According to a company statement, the contract option will cover drug substance engineering and scale-up process validation, long-term stability, and commercial readiness in support of its ongoing program for Ebanga. The US Food and Drug Administration (FDA) approved the drug, given as a single infusion, in December 2020 for the treatment of Ebola Zaire virus disease. 

The BARDA activities are part of plan to deploy treatments that can be deployed in outbreaks. The drug was initially developed by Ridgeback Biotherapeutics with support from BARDA. Ridgeback and Emergent signed an agreement that allows Emergent to make and distribute the drug in the United States and Canada.

The Infectious Diseases Society of America (IDSA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) are calling for world leaders to take "robust action" to mitigate the impact of antimicrobial resistance (AMR).

In a joint white paper published yesterday in CMI Communications, IDSA and ESCMID experts urged world leaders attending the upcoming United Nations (UN) High-Level Meeting on AMR to adopt a political declaration with "bold targets and practical steps" to accelerate progress against drug-resistant bacteria across the human, animal, agricultural, and environmental sectors. 

"To truly propel consequential, sustainable progress against AMR, the UN political declaration must include bold targets and be accompanied by robust financing," the groups wrote. "We urge all participants to agree on a global commitment to scale up action commensurate with the present threat of AMR, with the aim to reduce the global deaths caused by AMR by 10 percent by 2030."

Targets on antibiotic use, infection control

Among the targets recommended by IDSA/ESCMID to achieve that goal is for 70% of all antibiotic use globally to be from the group of antibiotics that the World Health Organization (WHO) defines as Access antibiotics—first- and second-line antibiotics with a narrow spectrum of activity that offer high therapeutic value with lower potential for resistance. They also call for a 30% reduction in the quantity of antibiotics used in the agri-food system.

To prevent the infections that drive global use of antibiotics, the groups say world leaders should set a goal of reaching 14 million children globally with essential immunization services, commit to scaling up implementation of the WHO's infection prevention and control guidelines to ensure that all nations have the core components in place, and improve access to clean water, sanitation, and hygiene.

We urge all participants to agree on a global commitment to scale up action commensurate with the present threat of AMR, with the aim to reduce the global deaths caused by AMR by 10 percent by 2030.

Other recommendations include rebuilding the antimicrobial drug pipeline, with a focus on developing a sustainable innovation ecosystem that can deliver drugs that target multidrug-resistant bacteria, strengthening and scaling up global AMR surveillance systems, and establishing an independent scientific panel for AMR mitigation.

"We strongly encourage them to work with our societies to help provide the scientific basis to guide this important work," they wrote.

UK-based biopharmaceutical company F2G today announced a $100 million financing round to advance late-stage development and commercialization of olorofim, a novel oral antifungal therapy for invasive aspergillosis and other invasive fungal infections.

Olorofim is the leading candidate from the orotomide class of antifungals, which work through a different mechanism of action than existing antifungal medications. It's currently being investigated in a phase 2b study in patients who have limited treatment options for rare and difficult-to-treat invasive fungal mold infections such as azole-resistant aspergillosis. Olorofim has received orphan drug status from the European Medicines Agency and the US Food and Drug Administration (FDA) and has been granted Qualified Infectious Disease Product designation by the FDA.

"This is a pivotal period for the company as we conclude the final stages of development and preparation for commercialization of olorofim in the US and elsewhere," F2G CEO Francesco Maria Lavino, MBA, said in a company press release. "If approved, olorofim is expected to be the first of a new class of antifungal agents with a novel, differentiated mechanism of action and will address genuine unmet needs in conditions with high morbidity and mortality."

An 'urgently needed' therapy

The financing round is being led by the AMR Action Fund, which was launched in 2020 with the aim of investing $1 billion to bring new antibiotics and antifungals to the market. AMR Action Fund CEO Henry Skinner, PhD, will join the F2G board of directors.

"For decades, clinicians have relied on a handful of antifungal classes, with few mechanisms of action and significant limitations due to spectrum of activity, drug toxicities, or drug-drug interactions," Skinner said. "These therapies are increasingly failing in patients. We are thrilled to support F2G’s team as they develop this urgently needed therapy and seek regulatory approval."