Vaccine News

Assembly Biosciences, Inc. today announced that the company will present data from its herpes simplex virus (HSV) program at the International Herpesvirus Workshop in Portland, Ore., July 13-17, 2024.

At the Workshop, Assembly Bio will present data describing the preclinical profile of ABI-5366, a long-acting helicase-primase inhibitor candidate in development for treating recurrent genital herpes.

Additionally, the company will present data highlighting the preclinical characterization of ABI-1179, a structurally distinct long-acting helicase-primase inhibitor candidate.

William Delaney, PhD, chief scientific officer of Assembly Bio, commented in a press release on May 22, 2024, "Improved therapeutic options are urgently needed for people living with recurrent genital herpes, as the current standard of care is only partially effective in controlling recurrences."

"Our HSV program employs a highly innovative approach, with candidates designed from the start for long-acting administration and targeting the viral helicase-primase complex, a different viral target than the standard of care."

"We look forward to an important year for the program, as we remain on track to begin dosing in a Phase 1a/1b study for ABI-5366 by mid-year (2024) and anticipate bringing ABI-1179 into the clinic by the end of the year."

Details of the presentations are as follows:

Poster Presentation: The Helicase-Primase Inhibitor ABI-5366 is a Novel, Potent, Long-Acting Inhibitor for the Treatment of Recurrent Genital Herpes
Presenter: Ran Yan, PhD, Assembly Bio
Poster Session Date and Time: Not Yet Available

As of May 23, 2024, there are no U.S. FDA-approved herpes vaccines available.

Following the initial shortage of the newly approved long-acting, monoclonal antibody Beyfortus™ (nirsevimab) for preventing infant respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI), a new digital app may help identify newborns at the highest risk for developing serious RSV LRTI, according to research published at the ATS 2024 International Conference.

 These researchers wrote, 'To predict whether these infants developed severe RSV LRTI requiring ICU admission during the first year of life, we developed a multivariable logistic regression model. The model includes demographic and clinical variables collected at or shortly after birth–19 variables, such as prenatal smoking, delivery method, maternal age, and assisted breathing (ventilation) during birth hospitalization.'

"Timely identification of infants at highest risk of RSV-related morbidity is key to prevention," said lead author Brittney M. Snyder, PhD, assistant professor, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, in a press release on May 21, 2024.

"Our personalized risk prediction tool may have applications in allocating expensive and/or limited immunoprophylaxis (immunization with nirsevimab or palivizumab) to achieve the greatest benefit and promote RSV prevention among families with high-risk infants."

During the 2023-2024 RSV peak season in the U.S., Beyfortus reduced RSV hospitalizations by about 82% in infants compared to infants who received no passive immunization against RSV.

As of March 2024, among females with an infant <8 months, 41.3% reported that their infant received Beyfortus.

As of May 2024, access to Beyfortus is not constrained in the U.S.

Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) today announced it would award $3.96 million to the Center for Vaccine Development and Global Health (CVD) at the University of Maryland School of Medicine to develop a maternal vaccine that prevents sepsis caused by Klebsiella pneumoniae in newborns and infants.

The CVD vaccine candidate, which targets the surface sugars of K. pneumoniae, is expected to be given to pregnant women, thereby protecting their babies from this deadly infection.

If successful, researchers expect the vaccine will prevent 80-90% of K. pneumoniae neonatal sepsis infections.

“With this award, the CVD team has even greater potential to bring a maternal vaccine for neonatal sepsis to market and save the lives of millions of infants worldwide, especially in low-and-middle income countries through its global partnership with Auro Vaccines of India,” said Erin Duffy, PhD, R&D Chief of CARB-X, in a press release on May 21, 2024.

“By vaccinating expectant mothers, the risk of neonatal sepsis might be reduced substantially as babies who are too young to be vaccinated would receive antibodies from their mothers in utero as well as through breastfeeding after birth.”

The CARB-X award supports examining the feasibility of this project to maximize its potential impact on the vulnerable patient population.

The CVD team aims to develop and evaluate their vaccine further in partnership with Auro Vaccines Private Limited, a step-down subsidiary of Aurobindo Pharma Limited, India.

Neonatal sepsis is a life-threatening response to bloodstream infections that occur in newborns fewer than 28 days old. Due to their immature immune systems, newborns are particularly susceptible to infections.

The BARNARDS study estimated that 2.5 million neonates or infants in the first month of life die annually of sepsis, with the most significant burden in low- and middle-income countries.

Since neonatal sepsis progresses rapidly, it requires immediate treatment with IV fluids and antibiotics. The risk of death from neonatal sepsis increases by 7.6% every hour a treatment is delayed.

Federal funds from the U.S. Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and others support CARB-X funding for this research.

The U.S. Centers for Disease Control and Prevention (CDC) recently reported a decrease in pediatric deaths related to influenza infections.

As of May 17, 2024, the CDC reported three additional influenza-associated pediatric deaths during Week #19, bringing the total number of pediatric deaths for this season to 167.

Two deaths were associated with influenza A viruses, and one was associated with an influenza B/Victoria virus. One of the influenza A viruses had subtyping performed and was an A(H3N2) virus.

Last flu season, the CDC reported 187 pediatric deaths related to influenza.

The CDC recommends that everyone six months and older get an annual flu vaccine as long as flu activity continues in their area.

According to the U.S. Centers for Disease Control and Prevention (CDC), the amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is low nationally.

As of May 17, 2024, the CDC says no jurisdictions experienced moderate, high, or very high activity last week.

Furthermore, nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are at low levels.

While there are approved vaccines that help prevent these diseases, the CDC suggests speaking with a healthcare professional about the best time to be immunized. 

During the early stages of the recent pandemic, AstraZeneca's Evusheld antibody was an effective therapeutic option. However, as the SARS-CoV coronavirus evolved, the U.S. FDA withdrew Evusheld's authorization in early 2023.

According to the company's press release on May 16, 2024, positive high-level results from the SUPERNOVA Phase III COVID-19 pre-exposure prophylaxis (prevention) trial showed sipavibart (AZD3152), an investigational long-acting antibody (LAAB), demonstrated a statistically significant reduction in the incidence of symptomatic COVID‑19 compared to control in an immunocompromised patient population.

SUPERNOVA is a large Phase III global trial providing the only efficacy data in immunocompromised patients, demonstrating the potential benefit of a COVID-19 antibody against recent SARS-CoV-2 variants.

Sipavibart was well tolerated in the trial, and preliminary analyses showed that adverse events were balanced between the control and sipavibart arms.

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, commented, "Immunocompromised patients currently have limited or no options for COVID-19 protection and continue to face a significant burden of disease, despite often being fully vaccinated."

"Sipavibart has the potential to prevent COVID-19 in the immunocompromised, and we will now work with regulatory authorities globally to bring sipavibart to these vulnerable patients."

Sipavibart is not a preventive vaccine.

It was engineered using the same antibody scaffold as Evusheld and optimized with the same half-life extension, reduced Fc effector function, and complemented the C1q binding platform.

The reduced Fc effector function aims to minimize the risk of antibody-dependent disease enhancement - a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection and/or disease.

According to the press release, AstraZeneca is in dialogue with regulatory authorities on potential authorization or approval pathways.