★ New AstraZeneca scientific achievements in the field of protection against infectious diseases at ECCMID 2024
AstraZeneca will present new clinical, real-world and preliminary data from its portfolio of vaccines and immunotherapies at ECCMID, the 34th European Congress of Microbiology and Infectious Diseases (now global ESCMID), which will be held in Barcelona from 27 to 30 April 2024. The company will present 19 abstracts at the meeting, including four oral presentations and four briefs, highlighting the need to protect people from the effects of infectious diseases and the importance of the role of antibodies and long-acting vaccines.
Data to be presented:
• Real-world evidence of the effectiveness of Beyfortus (nirsevimab), a long-acting antibody, for the prevention of hospitalizations due to respiratory syncytial virus (RSV).
• Updated evidence demonstrating the disproportionate burden of COVID-19 on immunocompromised people, highlighting the need for additional protection.
• Pharmacokinetics and safety data on sipavibart (AZD3152), an investigational long-acting antibody for the prevention of COVID-19 in immunocompromised patients.
• Active ingredient studies in early development, including late oral presentation of a novel mRNA-VLP vaccine platform and monoclonal antibody data to prevent recurrent C. difficile infection.
Iskra Reich, executive vice president of vaccines and immunotherapies at AstraZeneca, said: “We are pleased to share new data at ECCMID that demonstrates the progress of our portfolio of vaccines and immunotherapies in early and late stages, as well as our ambitions to deliver immunity. . long-term, which protects against infectious diseases using differentiated antibodies and vaccines. In addition to our innovative science, we are proud that our preventive treatments are helping to reduce the burden of respiratory infections and are presenting new real-world evidence demonstrating the effectiveness of our long-acting antibody nirsevimab in preventing RSV-related hospitalization in children. “Furthermore, our data shows that immunocompromised people continue to bear a significant and disproportionate burden of COVID-19, highlighting the need for additional protection.”
Real-world data highlight the impact of nirsevimab in preventing RSV-related hospitalizations.
New evidence from NIRSE-GAL, a study initiated by researchers based on a three-year follow-up in the Autonomous Community of Galicia, which analyzed the effectiveness of the 2023/2024 immunization campaign with the extension of this antibody. in a large pediatric population to reduce RSV-related hospitalizations. These data add to the extensive existing data on the effectiveness of the antibody, which has been demonstrated in clinical trials to provide protection against hospitalization due to RSV-associated lower respiratory tract infection.
Significant burden of Covid-19 on immunocompromised people
Five presentations, including an oral presentation, will highlight the ongoing risk and health burden of COVID-19 in immunocompromised people. The data will include an analysis of INFORM, a retrospective database study in England that examines the ongoing exponential risk of developing severe COVID-19 in different immunocompromised populations who have received multiple doses of COVID-19 vaccine. Evidence from the COVIDRIVE research platform (supported by the public-private collaboration id.DRIVE) highlights the disproportionate prevalence of immunodeficiency in patients with severe acute respiratory infection positive for SARS-CoV-2 in Europe.
Most notable AstraZeneca presentations at ECCMID
Nirsevimab
Universal prophylaxis with nirsevimab to prevent hospitalization in children due to respiratory syncytial virus. Longitudinal study in Galicia, Spain. Interruptive oral presentation, Date: 29.04.2024, Time: 11:00 – 12:00 CET
Sipavibart (AZD3152)
The pharmacokinetics and safety of the anti-SARS-CoV-2 monoclonal antibody AZD3152 are consistent with those of tixagevimab/cilgavimab. Latest news presentation, date: 30 April 2024, time: 12:00–13:30 CET
Safety of the sentinel cohort of the AZD5156/AZD3152 phase 1/3 SUPERNOVA study for the prevention of COVID-19 in immunocompromised participants. Final presentation, Date: 04/27/2024, Time: 12:00 – 13:30 CET
Evidence of COVID-19 in real life
People with multiple sclerosis are at high risk of hospitalization and death from COVID-19, despite high vaccination rates: findings from the INFORM study in England. Oral presentation, Date: 27.04.2024, Time: 08:30 – 10:30 CET
Continued increased risk of hospitalization and death from COVID-19 in immunocompromised individuals despite receiving ≥4 vaccine doses: Updated results from the 2023 INFORM, a retrospective observational health care database study in England. Final presentation, Date: 04/27/2024, Time: 12:00 – 13:30 CET
High prevalence of immunodeficiency among patients with severe acute respiratory infection, including SARS-CoV-2: results of a multicenter study of test-negative cases and controls. Final presentation, Date: 04/27/2024, Time: 12:00 – 13:30 CET
Immunocompromise, cancer, and other comorbidities in patients with severe acute respiratory infection testing positive or negative for SARS-CoV-2: a post hoc analysis of COVIDRIVE data from May 2021 to May 2023. Brief presentation, date: April 27, 2024 g., Time: 12:00–13:30 Central European Time.
COVIDRIVE: a European public-private partnership to collect real-world data on the effectiveness of COVID-19 vaccines. Final presentation, Date: 04/27/2024, Time: 12:00 – 13:30 CET
Preliminary data at the initial stages
An mRNA vaccine that expresses self-assembled antigen as virus-like particles provides a more potent, durable, and broader immune response against SARS-CoV-2 in animal models compared to native mRNA vaccines. Interruptive oral presentation, Date: 27.04.2024, Time: 14:45 – 15:45 CET
The toxin B neutralizing monoclonal antibody AZD5148 provides protection against Clostridioides difficile in a gnotobiotic piglet model. Final presentation, Date: 30.04.2024, Time: 12:00 – 13:30 CET
Ratings
Nirsevimab
It is a single-dose, long-acting antibody developed and marketed jointly by AstraZeneca and Sanofi using AstraZeneca’s YTE half-life extension technology. It is intended to protect newborns and children who have survived the first season of RSV, as well as children under 24 months of age who continue to be vulnerable to RSV disease during the second season of the virus. This antibody, given to newborns and children in a single dose, provides protection through an antibody that helps prevent lower respiratory tract infection caused by RSV without requiring activation of the immune system.
The administration of antibodies can be timed to coincide with the beginning of the RSV season.
This antibody has received regulatory designations to facilitate its accelerated development by various regulatory agencies around the world. It has been approved for use in the European Union, China and Japan and received approval from the US Food and Drug Administration (FDA) on the unanimous recommendation of the Antimicrobial Drug Advisory Committee. It is recommended by the Advisory Committee on Immunization Practices for use in children and is included in the childhood immunization program in the United States. Data from the US Centers for Disease Control and Prevention showed that in the 2023/2024 season. use of this antibody was associated with a 90% reduction in RSV-related hospitalizations in children presenting to the RSV site for the first time.
AZD3152
It is an investigational long-acting monoclonal antibody (LAAB) against COVID-19. It was designed to provide broad coverage of the Omnicrom variant and all ancestral variants by neutralizing the interaction of the spike protein with the host ACE2 receptor.
AZD3152 was developed from B cells donated by patients recovering from SARS-CoV-2 infection. It was developed using the same antibody structure as tixagevimab and cilgavimab and optimized using the same platform of increasing half-life and decreasing effector function of the crystallizable fragment (Fc) and binding to complement C1q. Reducing CF effector function is aimed at minimizing the risk of antibody-dependent increases in morbidity, a phenomenon in which virus-specific antibodies promote rather than suppress infection and/or disease.
AZD3152 was acquired by AstraZeneca in May 2022 from RQ Biotechnology.
Its safety and effectiveness are being studied in the global COVID-19 prevention clinical trial SUPERNOVA, with results expected in mid-2024.
Recommendations
1. Malla N. et al. Universal prophylaxis with nirsevimab to prevent hospitalizations in children caused by respiratory syncytial virus. Longitudinal study in Galicia, Spain. Oral presentation. 34th ECCMID World Conference; April 29, 2024; Barcelona, Spain.
2. Dube S et al. People with multiple sclerosis are at high risk of hospitalization and death due to COVID-19 despite high vaccination rates: findings from the England INFORM study. Oral presentation. 34th ECCMID World Conference; April 27, 2024; Barcelona, Spain.
3. Dube S et al. Continued increased risk of hospitalization and death due to COVID-19 in immunocompromised individuals despite receiving ≥4 doses of vaccine: updated results from the 2023 INFORM, a retrospective observational health care database study in England. Poster P0409. 34th ECCMID World Conference; April 27, 2024; Barcelona, Spain.
4. Bollaerts K. et al. COVIDRIVE: a European public-private partnership to collect real-world data on the effectiveness of COVID-19 vaccines. Poster P0380. 34th ECCMID World Conference; April 27, 2024; Barcelona, Spain.
5. Miraus V. et al. High prevalence of immunodeficiency among patients with severe acute respiratory infection, including SARS-CoV-2: results of a test-negative multicenter case-control study. Poster P0381. 34th ECCMID World Conference; April 27, 2024; Barcelona, Spain.
6. Miraus V et al. Immunocompromise, cancer and other comorbidities in patients with severe acute respiratory infection testing positive or negative for SARS-CoV-2: a post hoc analysis of COVIDRIVE data from May 2021 to May 2023. Poster P0382. 34th ECCMID World Conference; April 27, 2024; Barcelona, Spain.
7. Jones J.M. et al. Use of nirsevimab for the prevention of respiratory syncytial virus disease in infants and young children: recommendations of the Advisory Committee on Immunization Practices – USA, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(34):920-925.
8. AEMPS technical data sheet for Beyfortus (nirsevimab). https://cima.aemps.es/cima/pdfs/es/ft/1221689004/FT_1221689004.html.pdf (accessed April 2024)
9. Molin H.L. et al. Early Evaluation of the Efficacy of Nirsevimab to Prevent Respiratory Syncytial Virus-Related Hospitalization Among Infants Entering the First Respiratory Syncytial Virus Season – New Vaccine Surveillance Network, October 2023 – February 2024 MMWR Morb Mortal Wkly Rep . 2024;73:209–214.
10. Fransica J.R. et al. 1355. The SARS-CoV-2 monoclonal antibody AZD3152 effectively neutralizes historical and emerging variants and is being developed for the prevention and treatment of COVID-19 in high-risk individuals. Open the Infect Dis forum. 2023, November 27; 10 (Appendix 2): ofad500.1192. doi: 10.1093/ofid/ofad500.1192.
11. Van Erp E.A. and etc. Fc-mediated antibody effector functions in respiratory syncytial virus infection and disease. Front Immunol. 2019;10(March).
Fountain: AstraZeneca