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anti-H5N1 avian influenza antibodies (Fabenflu / FBF001)

✓ Approved

Fab'entech · 多克隆抗体 · 多克隆抗体

什么是 anti-H5N1 avian influenza antibodies？

anti-H5N1 avian influenza antibodies 是一种多克隆抗体，由Fab'entech研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intravenous (IV)。

药物档案

商品名Fabenflu, FBF001
公司Fab'entech
药物类别多克隆抗体, 抗体
给药途径Injectable (Others), Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, Fab'entech

治疗适应症

anti-H5N1 avian influenza antibodies 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Infections and infestationsInfluenza✓ Approved

相关研究文献

PubMedVaccines2026-07-27

Influenza B Vaccines: Current Landscape and Novel Development Strategies.

Kotlyarov Roman Y RY, Ravin Nikolai V NV, Mardanova Eugenia S ES

Influenza B virus (IBV) represents a significant global health threat, contributing 20-30% of annual influenza cases and causing substantial morbidity and mortality across all age groups. Current seasonal vaccines demonstrate variable effectiveness, highlighting the urgent need for next-generation approaches that provide enhanced and sustained protection against both IBV lineages. Moreover, continuous antigenic drift of circulating viruses progressively reduces the match between vaccine-induced antibodies and contemporary strains, necessitating broad-spectrum protection strategies. This review discusses influenza B virus control strategies, encompassing both conventional approaches and emerging vaccine technologies. While antiviral therapy, epidemiological surveillance, diagnostics, and non-pharmaceutical public-health measures are integral components of influenza B control, the present review focuses specifically on vaccine-based strategies. By critically appraising the available evidence, this review evaluates the extent to which these strategies may improve the effectiveness of IBV vaccines and, in the longer term, inform the prospect of reducing the burden of-or potentially eliminating-influenza B virus, a goal that remains hypothetical and requires clinical validation.

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PubMedVaccines2026-07-27

Pilot-Scale Downstream Processing of Recombinant Influenza Virus Vectors Expressing Brucella spp. Antigens Using an Integrated Membrane-Chromatography Purification Platform.

Assanzhanova Nurika N, Sagymbayeva Aigerim A, Shynybekova Gaukhar G, Shorayeva Kamshat K et al.

Background: Brucellosis remains a significant zoonotic infection affecting approximately 500,000 people worldwide annually, with no licensed human vaccine available. Recombinant influenza virus vectors expressing Brucella spp. antigens represent a promising vaccine platform. However, transitioning from laboratory constructs to clinical candidates requires validation of scalable purification methods compliant with Good Manufacturing Practice (GMP) standards. This study aimed to develop and optimize a pilot-scale purification protocol for these vectors. Methods: Recombinant influenza A viruses (H5N1) expressing Brucella spp. antigens (Omp16, Omp19, L7/L12, Cu-Zn SOD) were propagated in MDCK cell culture. The optimized purification process included: (1) clarification; (2) ultrafiltration/diafiltration (100 kDa MWCO); (3) two-step chromatography (anion-exchange Q-Sepharose® Fast Flow and multimodal Capto™ Core 700); and (4) sterile filtration. Process validation was performed across three independent pilot-scale batches (20 L each). Results: The purification process demonstrated high reproducibility for all constructs. Final preparations met established quality criteria: infectious titer ≥ 5.2 log10 TCID50/mL, hemagglutination activity 7.33 ± 0.58-8.33 ± 0.58 log2, total protein content 157-305 μg/mL, residual host cell DNA < 10 ng/dose, and bacterial endotoxin levels ≤ 0.15 IU/mL. The overall recovery of infectious virus was 20-24%, an optimal value for multi-stage bioprocessing. Preservation of the target genetic insert was confirmed in all final preparations by PCR and sequencing. Conclusions: The developed integrated purification protocol yields vectors with high purification efficiency, preserving biological activity and meeting regulatory quality requirements for residual host cell DNA and endotoxins. The technological platform demonstrated versatility, robustness (inter-batch coefficient of variation for yield did not exceed 10-12%), and scalability, establishing a foundation for preclinical and clinical studies of candidate brucellosis vaccines.

PMID 42506663
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PubMedVaccines2026-07-27

Evaluation of Immunogenicity and Cross-Protective Efficacy of a CpG-Adjuvanted Trivalent Inactivated Influenza Vaccine in Ferrets.

Qiu Yanping Y, Zhang Yan Y, He Shuangshuang S, Wang Yutian Y et al.

Background/Objectives: Pandemic influenza remains a persistent global threat, and while vaccination is the primary preventive measure, conventional vaccines often induce narrow, strain-specific immunity. This study evaluated the immunogenicity, protective efficacy, and cross-protective potential of a CpG-adjuvanted trivalent inactivated influenza vaccine (CpG-TIV) administered intramuscularly at high and low doses in ferrets. Methods: Groups of influenza-seronegative ferrets received two intramuscular injections, 3 weeks apart, of high- or low-dose CpG-TIV or a commercial non-adjuvanted trivalent vaccine. Three weeks after the second immunization (Day 42), serum was obtained, and the ferrets were subsequently challenged intranasally with homologous H1N1 and influenza B viruses, as well as a heterologous drifted H3N2 strain. Clinical signs, body weight, nasal viral load, and lung histopathology were monitored following the viral challenge. Results: CpG-TIV induced significantly higher dose-dependent HI and IgG antibodies than the commercial unadjuvanted vaccine. High-dose CpG-TIV markedly reduced weight loss, clinical symptoms, nasal viral load (by up to 99%), and lung pathological damage. Notably, high-dose CpG-TIV provided significant cross-protection against heterologous H3N2, whereas the commercial vaccine showed no protective effect. At Day 42, HI GMTs in the high-dose group reached 500, 254, and 594 against H1N1, H3N2, and B strains, respectively, with a maximal 2.58 log10 reduction in H1N1 viral load. Conclusions: High-dose CpG-TIV demonstrates strong immunogenicity and robust dose-dependent homologous and heterologous cross-protection in ferrets. The combination of a CpG adjuvant and high-dose antigen broadens protection against drifted influenza viruses, overcoming the narrow coverage of conventional vaccines. These data support further clinical development of this broad-spectrum influenza vaccine candidate.

PMID 42506652
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PubMedVaccines2026-07-27

A Double-Edged Sword: Breast Milk-Derived Maternal Antibodies and Infant Vaccine Responses: A Narrative Review.

Mpakosi Alexandra A, Moutsopoulou Rafaela Anna RA, Cholevas Stamatios S, Lianou Alexandra A et al.

Neonatal defense against pathogens relies on maternal antibodies transferred both through the placenta (IgG) and through breast milk (primarily secretory IgA). Maternal IgG antibodies are transferred across the placenta to the fetus mainly via the neonatal Fc receptor (FcRn), which is expressed at high levels in placental syncytiotrophoblasts, and results in the acquisition of maternal-fetal IgG. Transplacental transfer via the FcRn pathway can provide therapeutic proteins and protective antibodies following maternal vaccination. However, maternal IgG antibodies can bind to vaccine antigens such as measles, tetanus, and poliovirus, resulting in rapid clearance through FcgRIIB-mediated inhibition and inadequate B cell activation. In this way, they can inhibit de novo immune responses and significantly reduce vaccine response. On the other hand, the interference that breast milk-derived antibodies may have on vaccine-induced immunity is still largely unknown. Vaccination against influenza, pertussis, and COVID-19 during pregnancy or lactation has been shown to induce the production of protective, pathogen-specific, secretory IgA and IgG antibodies in breast milk. Conversely, studies found that breast milk-derived antibodies of vaccinated mothers reduced vaccine-induced immunity in breastfed infants by accelerating the clearance of vaccine antigen, resulting in reduced antigen availability and reduced plasma cell formation after vaccination. Additional factors in middle- and low-income countries, including environmental (increased microbiome diversity, environmental intestinal dysfunction, malnutrition, co-infections) and breastfeeding practices, may exacerbate the interference effect of maternal antibodies. Current evidence supports that breastfeeding is associated with a reduced immunological response exclusively to the rotavirus vaccine. However, the limited evidence base to date precludes definitive conclusions regarding the role of breast milk-derived antibodies in modulating vaccine-induced immunity. Nevertheless, the evidence suggests that although maternal antibodies may theoretically reduce vaccine immunogenicity, the overall protective benefits of breastfeeding outweigh any potential interference with vaccine responses.

PMID 42506596
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PubMedMedical sciences (Basel, Switzerland)2026-07-27

Pharmacological and Clinical Heterogeneity of Anti-Amyloid Monoclonal Antibodies in Early Alzheimer's Disease: A Systematic Review and Meta-Analysis of Randomized Trials.

Vamanu Albert A, Mastaleru Alexandra A, Schreiner Thomas Gabriel TG, Popescu Gabriela G et al.

Background: Anti-amyloid monoclonal antibodies represent the first disease-modifying therapeutic strategy targeting amyloid-β pathology in early Alzheimer's disease (AD). Although several agents have demonstrated the ability to reduce cerebral amyloid burden, their clinical efficacy and safety remain subjects of substantial scientific and regulatory debate. This study aimed to synthesize randomized evidence evaluating the benefit-risk profile of anti-amyloid monoclonal antibodies in biomarker-confirmed early AD. Methods: A systematic review and classical pairwise meta-analysis of randomized controlled trials (RCTs) was conducted following the PRISMA 2020 guidelines. PubMed/MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were searched for phase III placebo-controlled trials evaluating lecanemab, donanemab, aducanumab, and gantenerumab in patients with mild cognitive impairment due to AD or mild AD dementia with biomarker confirmation of amyloid pathology. The primary outcome was change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at the longest available follow-up. Safety outcomes included amyloid-related imaging abnormalities with edema or effusion (ARIA-E), amyloid-related imaging abnormalities with hemorrhage (ARIA-H), serious adverse events, and treatment discontinuation. Random-effects meta-analyses were performed. Results: Six randomized comparisons derived from four phase III trials involving 7695 participants met the eligibility criteria. Anti-amyloid monoclonal antibodies were associated with a statistically significant slowing of clinical progression compared with placebo (pooled mean difference in CDR-SB: -0.42 points; 95% CI -0.59 to -0.25; I2 = 78%). The observed effect was primarily driven by trials of lecanemab and donanemab, whereas aducanumab demonstrated discordant results across trials and gantenerumab showed no clinically meaningful benefit. Despite statistical significance, the magnitude of the pooled effect approached the lower boundary of the minimal clinically important difference reported for CDR-SB in early AD. Treatment was associated with a markedly increased risk of ARIA-E (pooled risk ratio 10.1; 95% CI 7.8-13.0), with moderate heterogeneity across studies. Most ARIA-E events were asymptomatic and detected through protocol-mandated MRI monitoring. Conclusions: In biomarker-confirmed early Alzheimer's disease, anti-amyloid monoclonal antibodies produce a statistically significant but modest slowing of clinical decline accompanied by a substantially increased risk of ARIA. The benefit-risk profile appears heterogeneous across individual antibodies and may reflect pharmacological differences in amyloid targeting and clearance mechanisms. These findings support cautious, individualized use of anti-amyloid therapies and highlight the need for longer-term studies to determine whether short-term slowing of decline translates into clinically meaningful disease modification.

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PubMedArthritis & rheumatology (Hoboken, N.J.)2026-07-27

Anti-carbamylated fibrinogen autoantibodies of IgG and IgA isotypes contribute to a better prognostic stratification in very early rheumatoid arthritis: data from the French national ESPOIR cohort.

Brevet Pauline P, Guérin Olivia O, Le Goaréguer Léna L, Halbourg Élisa É et al.

To investigate the prevalence and longitudinal evolution of anti-carbamylated fibrinogen antibodies (ACa-Fib) of IgG and IgA isotypes in early rheumatoid arthritis (RA), and determine whether these antibodies provide additional diagnostic and prognostic information beyond anti-cyclic citrullinated peptide antibodies (anti-CCP) and rheumatoid factors (RF). ACa-Fib IgG and IgA were quantified by in-house ELISA at baseline (M0), 6 months (M6), and 24 months (M24) in 619 patients with available 2010 ACR/EULAR classification criteria, including 575 RA patients, from the French ESPOIR cohort. Clinical, biological, and radiographic data were collected. Multivariable models and appropriate statistical analyses were used to assess associations between ACa-Fib levels and disease activity, therapeutic response, smoking exposure, CRP concentrations, and structural progression. At baseline, ACa-Fib IgG and IgA were detected in 16.6% and 6.3% of anti-CCP-negative RA patients, respectively. Baseline ACa-Fib levels were not associated with therapeutic response or remission. Over 24 months, ACa-Fib IgG levels decreased whereas IgA levels remained stable. Higher ACa-Fib IgA levels were associated with longer smoking duration (p=0.003) and cumulative smoking exposure (p=0.016). Patients in the highest quartile of ACa-Fib IgG (≥20.29 AU) had an increased risk of rapid radiographic progression (global p=0.004). Despite its markedly lower prevalence, ACa-Fib IgA (≥3.07 AU) was also associated with structural progression (OR=1.9, 95% CI 1.1-3.4, p=0.031). The distinct longitudinal behaviour and prognostic associations of ACa-Fib IgG and IgA highlight a previously underappreciated component of the anti-CarP response and support their utility as complementary biomarkers for improved risk stratification in early RA.

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