zolmitriptan intracutaneous microneedle system (C213) / Gylden Pharma - LARVOL DELTA

The multi-specific V-based Humabody CB213 co-targets PD1 and LAG3 on T cells to promote anti-tumour activity. (PubMed, Br J Cancer) - "CB213 is poised to enter clinical development and, through intercepting both PD1 and LAG3 resistance mechanisms, may benefit patients with tumours escaping front-line immunological control."

Journal • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • LAG3 • PD-1 • PD-L1

Invasive serogroup B meningococci in England following three years of 4CMenB vaccination - first real-world data: Meningococcal B following 4CMenB. (PubMed, J Infect) - "4CMenB reduces disease due to strains with cross-reactive antigen variants. No increase in absolute numbers of cases due to poorly covered strains was observed in the study period."

Clinical • Journal • Real-world evidence • Infectious Disease • Meningococcal Infections

Differentially Amplified Repetitive Sequences Among Aegilops tauschii Subspecies and Genotypes. (PubMed, Front Plant Sci) - "However, two Ty3/gypsy retrotransposons (CL62 and CL87) showed significantly higher abundances, and CL1, CL119, CL213, CL217 tandem repeats, and CL142 retrotransposon (Ty1/copia type) showed significantly lower abundances in subspecies strangulata compared with the subspecies anathera and meyeri...Taken together, the different classes of repetitive DNA sequences have differentially accumulated between strangulata and the other two subspecies of Ae. tauschii that is generally in agreement with spike morphology, implying that factors affecting repeatome evolution are variable even among highly closely related lineages."

Journal

Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches (clinicaltrials.gov) - P2/3; N=42; Completed; Sponsor: Zosano Pharma Corporation; Active, not recruiting ➔ Completed; Trial completion date: Jul 2021 ➔ Apr 2021; Trial primary completion date: Jul 2021 ➔ Apr 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • Chronic Cluster Headache • Pain

[VIRTUAL] Frequency and spectrum of mutations in the BRCA1, BRCA2, PALB2, P53, PTEN, CHEK2, CDH1 genes in women from 3 cities of Colombia (SG-BCC 2021) - "Six pathogenic mutations (frequency of 4.4%) were found in these patients: BRCA1: C.5186C>A, C.178C>T and C.213–12A>G, BRCA2: C.7007+1G>A y C.631+3A>G and TP53: C.586C>T. one variant of uncertain significance showed pathogenic evidence in silico (CHEK2: C.497A>G) and it was found in three cases. Conclusion(s): This is the first study in Colombia that evaluates genes different from BRCA1 and BRCA2 in unselected cases in Colombia, and the frequency of pathogenic mutations was 4.4%."

Clinical • Breast Cancer • Oncology • Solid Tumor • BRCA1 • BRCA2 • CDH1 • CHEK2 • PALB2 • PTEN • TP53

Molecular characterization of invasive serogroup B Neisseria meningitidis isolates from Spain during 2015-2018: evolution of the vaccine antigen factor H binding protein (FHbp). (PubMed, J Infect) - "Due to invasive meningococcal strains temporal variability (eg prevalence of the cc213 increased from 3.6% in 2007 to 33% in 2018) affecting to the presence and distribution of the vaccine antigens, continuous detailed meningococcal surveillance and monitoring of the vaccine antigens is needed to determine the degree and durability of coverage provided by these protein vaccine."

Journal • Immunology • Infectious Disease

Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches (clinicaltrials.gov) - P2/3; N=41; Active, not recruiting; Sponsor: Zosano Pharma Corporation; Recruiting ➔ Active, not recruiting; N=120 ➔ 41

Clinical • Enrollment change • Enrollment closed • Chronic Cluster Headache • Pain

Genomic surveillance of Neisseria meningitidis serogroup B invasive strains: Diversity of vaccine antigen types, Brazil, 2016-2018. (PubMed, PLoS One) - "During the study period, changes in the clonal structure of circulating strains were observed, without a predominance of a single hyperinvasive lineage, indicating that an epidemiologic shift has occurred that led to a diversity of vaccine antigen types in recent years in Brazil."

Journal • Infectious Disease

Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches (clinicaltrials.gov) - P2/3; N=120; Recruiting; Sponsor: Zosano Pharma Corporation; Active, not recruiting ➔ Recruiting; N=20 ➔ 120; Trial completion date: Apr 2021 ➔ Jul 2021; Trial primary completion date: Apr 2021 ➔ Jul 2021

Clinical • Enrollment change • Enrollment open • Trial completion date • Trial primary completion date

Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches (clinicaltrials.gov) - P2/3; N=20; Active, not recruiting; Sponsor: Zosano Pharma Corporation; Recruiting ➔ Active, not recruiting; N=120 ➔ 20

Clinical • Enrollment change • Enrollment closed

Assessment of spanlastic vesicles of zolmitriptan for treating migraine in rats (Dovepress) - "We found decreased Tmax, increased Cmax, AUC0–6, AUC0–∞ and ameliorated behaviour in rats (head scratching) treated with intranasal SLs compared to oral commercial zolmitriptan. Our study substantiates the enhanced efficacy of Zol SLs in brain targeting for migraine treatment."

Preclinical

Zosano Pharma Reports Third Quarter 2019 Financial Results and Provides Corporate Update (GlobeNewswire, Zosano Pharma Corporation) - "Zosano Pharma Corporation...today announced financial results for the third quarter ended September 30, 2019, as well as recent business highlights....'We are finalizing our New Drug Application for Qtrypta for the acute treatment of migraine, which we expect to file with the FDA by the end of the year'....Began enrolling patients in the Phase 2/3 clinical study evaluating the efficacy of C213 for the acute treatment of cluster headache....Presented multiple positive datasets from the Qtrypta™ long-term safety study at the Congress of the International Headache Society"

Clinical data • Enrollment status • Regulatory

Zosano Pharma initiates phase 2/3 clinical study in cluster headache (GlobeNewswire) - "Zosano Pharma Corporation...today announced that the company has begun enrolling cluster headache patients in the ATAC clinical trial. This Phase 2/3 study will evaluate the efficacy of C213 for the acute treatment of cluster headache."

Enrollment status

Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches (clinicaltrials.gov) - P2/3; N=120; Recruiting; Sponsor: Zosano Pharma Corporation; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches (clinicaltrials.gov) - P2/3; N=120; Not yet recruiting; Sponsor: Zosano Pharma Corporation

Clinical • New P2/3 trial