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Clover Biopharmaceuticals, Ltd. today announced positive preliminary immunogenicity and safety data in the older adult cohort from its Phase 1 clinical trial evaluating SCB-1019, the company's bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine candidate, which is based on Clover's Trimer-Tag vaccine technology platform.
Results indicate that SCB-1019 could potentially have a differentiated and favorable safety and reactogenicity profile compared to currently approved oil-in-water adjuvanted4 and/or mRNA5-based RSV vaccines.
"As the first RSV PreF vaccine candidate developed in China to enter the clinical trial stage and generate clinical data, SCB-1019 .... demonstrate broad and significant neutralizing antibody responses against both RSV-A and RSV-B as well as a favorable tolerability profile," said Joshua Liang, Chief Executive Officer & Board Director of Clover, in a press release on June 18, 2024.
"We look forward to the full clinical readout by the end of 2024 to support further development and strengthen our potentially differentiated profile for markets globally."
Preliminary results for RSV-neutralizing antibodies (nAbs) and safety for SCB-1019 at the selected dose level are summarized below:
Immunogenicity Results:
RSV-A nAbs: SCB-1019 induced geometric mean titers (GMTs) in RSV-A nAbs of up to 7,906 IU/mL compared to 1,078 IU/mL for placebo at Day 28.
RSV-B nAbs: SCB-1019 induced GMTs in RSV-B nAbs of up to 46,674 IU/mL compared to 12,185 IU/mL for placebo at Day 28.
Geometric Mean Fold Rise (GMFR): High baseline nAb titers at Day 0 (pre-vaccination), especially to RSV-B, were observed, potentially reflecting recent outbreaks near the clinical trial sites.
Thus, sub-analysis in subjects with the lowest quartile baseline nAb titers was performed: GMFRs for SCB-1019 were up to 8-fold for RSV-A nAbs and 11-fold for RSV-B nAbs at Day 28 compared to Day 0 (pre-vaccination). No increases in RSV-A or RSV-B nAbs were observed for the placebo on Day 28.
nAb results across both RSV-A and RSV-B appear to be in line or potentially favorable compared to other protein subunit RSV PreF vaccines.
Given that other monovalent RSV-A vaccines have previously observed lower immune responses and/or efficacy against RSV-B, we continue to support Clover's bivalent RSV-A/B approach, wrote the company.
Results further confirm that Clover's PreF antigens in SCB-1019 are in the stabilized prefusion and trimeric fo. This is additionally supported by exploratory immunogenicity results demonstrating significant increases in Site Ø and Site V nAb-competitive titers.
Safety & Reactogenicity Results: SCB-1019 was generally well-tolerated. Local and systemic adverse events (AEs) were generally mild and comparable to saline placebo. No serious adverse events, adverse events of special interest, or AEs leading to discontinuation were observed.
These preliminary results in older adults & elderly cohort (aged 60-85) are consistent with the positive results in younger adults (aged 18-59) announced earlier this year.
As of June 18, 2024, the U.S. FDA has approved three RSV vaccines and one monoclonal antibody (Beyfortus) for infants for the 2024-2025 RSV season.
Bavarian Nordic A/S today announced the completion of the rolling submission process with the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA) for the licensure of its CHIKV VLP vaccine candidate for immunization against chikungunya virus infection in individuals 12 years of age and older.
CHIKV VLP is an adjuvanted VLP-based vaccine candidate for active immunization against chikungunya disease.
Initiated in April 2024, with acceptance from the FDA, the BLA could support a potential vaccine approval in the first half of 2025.
Bavarian Nordic also intends to submit a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) by the end of the first half of 2024. The MAA has already been granted accelerated assessment, which means the CHIKV VLP vaccine could obtain approval from the European Commission in the first half of 2025.
“The completion of the BLA submission marks a significant milestone in the development of our CHIKV VLP vaccine and represents an important contribution to the development of preventative solutions for individuals 12 years of age and older at risk of chikungunya virus from bites by infected mosquitos. With the near-term anticipated MAA submission to EMA, we are looking towards potential approval of the vaccine in the first half of 2025 and subsequent launch in both the U.S. and E.U.,” said Paul Chaplin, President and CEO of Bavarian Nordic, in a press release on June 17, 2024.
In the United States, the FDA has approved one chikungunya vaccine.
Chikungunya is a mosquito-borne viral disease that causes fever and severe joint pain. The World Health Organization (WHO) says the disease was first recognized in 1952. It is a ribonucleic acid virus belonging to the alphavirus genus of the family Togaviridae.
The WHO says chikungunya outbreaks have been identified in nearly 115 countries, primarily in the Region of the Americas. Most chikungunya cases in the contentital USA are travel related.
Today's dynamic digital vaccine news typically involves fact-checking by trusted third parties, but it rarely includes a manufacturer openly responding to a potentially biased article.
Recently, the news industry has been challenged in its ability to comprehend vaccine-related clinical trials and technical journal articles.
For example, on June 16, 2024, The Economic Times published a headline stating, 'Bharat Bio's Rotavirus vaccine Rotavac may be unsafe for children: Study.'
Later that day, the company posted on X its response....Unfair Journalistic Practices and Breach of Ethics by The Economic Times.
While this vaccine efficacy debate may be illuminated on social media for days and probably never settled, vaccine hesitancy and reduced trust in the healthcare delivery system will continue.
In most countries, government agencies, such as the U.S. FDA, play vital roles in communicating virology (vaccines, immunotherapies, gene therapy, monoclonal antibodies) risks and benefits, not media-centric fiction.
Novavax, Inc. today announced that it has submitted an amendment to its Emergency Use Authorization to the U.S. Food and Drug Administration (FDA) for its updated JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older.
The submission aligns with guidance from the U.S. FDA, the European Medicines Agency, and the World Health Organization to target the JN.1 lineage during late 20204.
As discussed at the recent FDA meeting, targeting JN.1, the parent strain of the most common currently circulating SARS-CoV-2 virus variants has a public health benefit.
Novavax's JN.1 vaccine has demonstrated broad cross-neutralizing antibodies against multiple variant strains, including KP.2 and KP.3, indicating the potential to protect against forward drift variants.
"Novavax is committed to having a protein-based COVID-19 option available at the start of the vaccination season, which is critical because research suggests that providing vaccine choice, along with healthcare provider recommendations, may help improve vaccination rates," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on June 14, 2024.
Nonclinical data have demonstrated that Novavax's JN.1 vaccine induces broad neutralization responses to JN.1 lineage viruses, including those containing the F456L and R346T mutations, and to "FLiRT" and "FLuQE" variants.
Novavax's vaccine also produces conserved polyfunctional, Th1-biased CD4+ T cell responses to a range of JN.1 lineage variants.2 Novavax's updated JN.1 COVID-19 vaccine targets the "parent strain" of KP.2 and KP.3.
Novavax intends to have doses in the U.S. for distribution by mid-July. Upon FDA authorization and U.S. CDC recommendation, Novavax is preparing to deliver to U.S. customers promptly. Novavax is also working with other regulatory authorities globally to authorize or approve its JN.1 COVID-19 vaccine.
The U.S. Biomedical Advanced Research and Development Authority (BARDA) today announced up to $500 million in Project NextGen funding for multiple Phase 2b clinical trials to evaluate novel vaccines administered as a nasal spray or as a pill to protect against symptomatic COVID-19.
While currently approved COVID-19 vaccines are administered intramuscularly, they are limited in their capacity to induce a robust immune response in mucosal areas such as the mouth, nose, and gut, where the SARS-CoV-2 coronavirus first enters people.
Successful development of intranasal and oral vaccines would provide safe, effective, needle-free, easier-to-administer options with the potential to improve vaccine access.
“We learned a lot during the COVID-19 pandemic that we can use to better prepare for future public health crises. That includes finding new ways to administer vaccines to make it even easier for everyone to protect themselves from illness,” U.S. HHS Secretary Xavier Becerra said in a press release on June 13, 2024.
The project awards were made to:
Up to $453 million to Vaxart of San Francisco, California, developing an oral pill vaccine candidate, adenovirus serotype 5. BARDA will provide an initial $65.7 million for early trial milestones, with remaining funds provided as the effort successfully advances toward trial execution. Vaxart will execute its own Phase 2b clinical trials.
Approximately $34 million was donated to Castlevax, part of the Mount Sinai Health System in New York City, to develop an intranasal vaccine candidate, CVAX-01.
Approximately $40 million will go to Cyanvac of Athens, Georgia, to develop an intranasal vaccine candidate, CVXGA.
Castlevax and Cyanvac Phase 2b trials are in partnership with BARDA’s Clinical Studies Network.
These awards are just one component of BARDA’s Project NextGen medical countermeasures portfolio. To date, BARDA has leveraged more than $2 billion in Project NextGen funding to support the development of next-generation vaccines, treatments, and enabling technologies.
As of June 14, 2024, the U.S. government has approved three COVID-19 vaccines, while the World Health Organization has qualified 13 vaccines.
Sysmex Astrego AB announced today that it was awarded the Longitude Prize for antimicrobial resistance for developing a rapid antimicrobial susceptibility test for urinary tract infections (UTIs).
Sysmex Astrego received the $10.2 million award to incentivize the development of transformative point-of-care tests that will improve antibiotic treatment decisions.
Using a 400 microlitre urine sample on a smartphone-sized cartridge, the PA-100 AST System test can identify the presence of bacterial infections such as UTIs in just 15 minutes.
The goal is to replace the 2-3 day lab test process.
"Winning the Longitude Prize is the first true and biggest recognition that what we have been doing all these years was for a very important global cause," Ozden Baltekin, PhD, Sysmex Astrego director of program management, said in a press release on June 12, 2024.
Sysmex Astrego launched the PA-100 AST System in Europe in 2023 and intends to accelerate global expansion efforts.
UTIs are the most common bacterial infection, and around 50-60% of women develop one in their lifetime.
As of June 13, 2024, a UTI vaccine is available in certain countries, and new therapies are conducting late-stage development.
