Zabolante (zabofloxacin) / Dong Wha - LARVOL DELTA

An Autologous NK/CIK Cell Product (PB101) in Combination With EGFR-TKI for Treating Lung Cancer (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Precision Biotech Taiwan Corp.

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Novel Therapeutic Effect of VEGF Decoy Receptor Fusion Protein, VEGF-Grab, in Chronic Inflammatory Diseases (EULAR 2025) - "VEGF-Grab (designated as PB101 and its improved version PB102), an Fc fusion protein containing VEGFR1’s second and third Ig-like domains, demonstrates enhanced anti-angiogenic effects through novel glycosylation sites that reduce nonspecific ECM binding [4]. VEGF-Grab effectively inhibits PlGF-induced angiogenesis and reduces the pathogenic activities of RA-FLSs and Th17 cells. Its therapeutic efficacy was validated in both RA and MS animal models, with its improved version PB102 showing enhanced pharmaceutical properties and superior efficacy. By simultaneously targeting angiogenesis and inflammatory cell activity, VEGF-Grab represents a promising dual-target therapeutic approach for autoimmune diseases."

CNS Disorders • Inflammation • Inflammatory Arthritis • Multiple Sclerosis • Oncology • Rheumatoid Arthritis • Rheumatology • CSF2 • FLT1 • IFNB1 • IL17A • KDR • VEGFA

pb101: Press Briefing (EHA 2024) - No abstract available

Phase I Study to Evaluate Safety and Anti-tumor Activity of PB101, an Anti-angiogenic Immunomodulating Agent (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Panolos Bioscience

Immunomodulating • Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor • FLT1

Advancements in the Management of Severe Community-Acquired Pneumonia: A Comprehensive Narrative Review. (PubMed, Cureus) - "New drugs such as omadacycline, delafloxacin, and zabofloxacin have shown valid evidence for the treatment of resistant causative organisms. The main guidelines for preventing sCAP include maintaining a healthy lifestyle, and annual pneumococcal and influenza vaccines are recommended for the most vulnerable patient groups, such as those with COPD and immunosuppression."

Journal • Review • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Inflammation • Influenza • Pneumococcal Infections • Pneumonia • Pulmonary Disease • Respiratory Diseases • Septic Shock

Phase I Study to Evaluate Safety and Anti-tumor Activity of PB101, an Anti-angiogenic Immunomodulating Agent (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Panolos Bioscience | Not yet recruiting ➔ Recruiting

Enrollment open • Immunomodulating • Metastases • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

Phase I Study to Evaluate Safety and Anti-tumor Activity of PB101, an Anti-angiogenic Immunomodulating Agent (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Panolos Bioscience

Immunomodulating • Metastases • New P1 trial • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

PB101, a VEGF- and PlGF-targeting decoy protein, enhances antitumor immunity and suppresses tumor progression and metastasis. (PubMed, Oncoimmunology) - "Combining PB101 and anti-PD-L1 could establish durable protective immunity against tumor recurrence and metastasis. The findings of this study offer scientific rationales for further clinical development of PB101, particularly when used in combination with immune checkpoint inhibitors, as a potential treatment for advanced cancers."

Journal • Oncology • CD8 • FLT1 • IFNG

pb101 Press Briefing (EHA 2023) - "Sponsored by Press"

Development of an Agrobacterium-delivered codon-optimized CRISPR/Cas9 system for chickpea genome editing. (PubMed, Protoplasma) - "This study transformed the single cotyledon half-embryo explants using CaMV35S promoter to drive two marker genes (β-glucuronidase gene; GUS and green fluorescent protein; GFP) through binary vectors pBI101.2 and modified pGWB2, respectively. A simple, rapid, highly reproducible, stable transformation and CRISPR/Cas9-based genome editing system for chickpea was established. This study aimed to demonstrate this system's applicability by performing a gene knockout of the chickpea PDS gene using an improved chickpea transformation protocol for the first time."

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Overview of Side-Effects of Antibacterial Fluoroquinolones: New Drugs versus Old Drugs, a Step Forward in the Safety Profile? (PubMed, Pharmaceutics) - "The FDA and EMA approved delafloxacin. Additionally, lascufloxacin, levonadifloxacin, nemonoxacin, sitafloxacin, and zabofloxacin were approved in their origin countries...The main AEs of the FQs class were addressed, highlighting the existing data for the recently approved ones. In addition, the general management of AEs when they occur and the rational use and caution of modern FQs were outlined."

Adverse events • Journal • Review • Infectious Disease

Glandular trichome specificity of menthol biosynthesis pathway gene promoters from Mentha × piperita. (PubMed, Planta) - "Several cis-elements including Myb-binding motifs together confer glandular trichome specificity as revealed from heterologous expression and analysis of menthol biosynthesis pathway gene promoters. Glandular Trichomes (GTs) are result of division of epidermal cells that produce diverse metabolites. Species of mint family are important for their essential oil containing many high-value terpenoids, biosynthesized and stored in these GTs. Hence, GTs constitute attractive targets for metabolic engineering and GT-specific promoters are important. In this investigation, the upstream regions of the Mentha × piperita menthol biosynthetic pathway genes (-)-limonene synthase, (-)-P450 limonene-3- hydroxylase, (-)-trans-isopiperitenol dehydrogenase, (-)-Isopiperitenone reductase, ( +)-Pulegone reductase, (-)-Menthone reductase/ (-)-Menthol dehydrogenase and a branched pathway gene ( +)-menthofuran synthase were isolated and characterized. These fragments, fused to..."

Journal

Potential new fluoroquinolone treatments for suspected bacterial keratitis. (PubMed, BMJ Open Ophthalmol) - "For example, the new generation FQs, avarofloxacin, delafloxacin, finafloxacin, lascufloxacin, nadifloxacin, levonadifloxacin, nemonoxacin and zabofloxacin have good activity against the common ophthalmic pathogens such as Staphylococcus aureus, Pseudomonas aeruginosa, Streptococcus pneumoniae and several of the Enterobacteriaceae However, because there are no published ophthalmic break-point concentrations, the susceptibility of an isolated micro-organism to a topical FQ is extrapolated from systemic break-point data and wild type susceptibility. Notably, we found significant variation in the reported corneal and aqueous FQ concentrations so that reliance on the reported mean concentration may not be appropriate, and the first quartile concentration may be more clinically relevant. The provision of the MIC for the microorganism together with the achieved lower (first) quartile concentration of a FQ in the cornea could inform management decisions such as whether to..."

Journal • Review • Infectious Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology • Pneumococcal Infections • Pneumonia

Bacterial etiology and pneumococcal urinary antigen in moderate exacerbation of chronic obstructive pulmonary disease. (PubMed, J Thorac Dis) - "This study was a post hoc analysis of a randomized controlled trial designed to compare oral zabofloxacin with moxifloxacin for treating outpatients with moderate AECOPD...The bacterial prevalence in patients with moderate AECOPD in South Korea showed correlations with the global prevalence, without significant regional differences. In outpatient settings, UAT has the potential to be used as a supplemental tool with sputum culture as a guide for determining the suspicion of bacterial exacerbation."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pneumococcal Infections • Pneumonia • Pulmonary Disease • Respiratory Diseases

Delafloxacin, Finafloxacin, and Zabofloxacin: Novel Fluoroquinolones in the Antibiotic Pipeline. (PubMed, Antibiotics (Basel)) - "The introduction of these novel fluoroquinolones into daily practice extends the possible indications of antibiotics into different bacterial infections, and provides treatment options in difficult-to-treat infections. However, some reports of delafloxacin resistance have already appeared, thus underlining the importance of the prudent use of antibiotics."

Journal • Review • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Otorhinolaryngology • Pneumonia • Pulmonary Disease • Respiratory Diseases

Discovery and Development of Antibacterial Agents: Fortuitous and Designed. (PubMed, Mini Rev Med Chem) - "These include solithromycin, plazomicin, lefamulin, omadacycline, eravacycline, delafloxacin, zabofloxacin, finafloxacin, nemonoxacin, gepotidacin, zoliflodacin, cefiderocol, BAL30072, avycaz, zerbaxa, vabomere, relebactam, tedizolid, cadazolid, sutezolid, triclosan and afabiacin. This article aims to review the investigational and recently approved antibacterials with a focus on their structure, mechanisms of action/resistance, and spectrum of activity. Delving deep, their success or otherwise in various phases of clinical trials is also discussed while attributing the same to various causal factors."

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Structural Characterization of the Millennial Antibacterial (Fluoro)Quinolones-Shaping the Fifth Generation. (PubMed, Pharmaceutics) - "Special attention is given to eight representatives: besifloxacin, delafoxacin, finafloxacin, lascufloxacin, nadifloxacin and levonadifloxacin, nemonoxacin, and zabofloxacin. Antibacterial quinolones class continues to acquire new compounds with antibacterial potential, among other effects. Numerous derivatives, hybrids or conjugates are currently in various stages of research."

Journal • Review

Investigational and Experimental Drugs for Community-Acquired Pneumonia: the Current Evidence. (PubMed, J Exp Pharmacol) - "Delafloxacin, omadacycline and lefamulin are the most recently approved antibiotics for CAP...New antimicrobials, such as solithromycin and nemonoxacin, are currently being studied in Phase III clinical trials...These include zabofloxacin, aravofloxacin, nafithromycin, TP-271, gepotidacin, radezolid, delpazolid, and CAL02. The preliminary results of these clinical trials allow us to assure that most of these drugs may play a role in the future treatment of CAP."

Journal • Review • Infectious Disease • Pneumonia • Respiratory Diseases

Clinical Role of the Chronic Obstructive Pulmonary Disease Assessment Test in Prediction of the Response to Treatment for Exacerbations. (PubMed, J Korean Med Sci) - P3 | "Early improvement in CAT scores may be associated with a more favorable response to the treatment of COPD exacerbations."

Clinical • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Emerging antibiotics for Community-Acquired Pneumonia. (PubMed, Expert Opin Emerg Drugs) - "We provide a summary of the latest approved drugs for this indication and highlight emerging drugs with a potential indication.Expert opinion: Ceftaroline (a new cephalosporine) and omadacycline (a cycline alternative), either parenterally or orally, are the only two new antibiotics to have been approved by the FDA for the treatment of community-acquired pneumonia in the last five years. Among the antimicrobials in development, Lefamulin (the first pleuromutilin), is currently in phase III development. Among the known antibiotic classes, solithromycin (a macrolide), nemonoxacin (a quinolone), and delafloxacin and zabofloxacin (both fluoroquinolones), have been studied in phase II and III in clinical trials. The availability of these new antibiotics may offer opportunities to improve the empirical treatment for community-acquired pneumonia."

Journal • Immunology • Infectious Disease • Pneumonia • Respiratory Diseases

Evaluation of Pharmacokinetics Profiles and Bactericidal Activity of Zabofloxacin (clinicaltrials.gov) - P1; N=18; Completed; Sponsor: Dong Wha Pharmaceutical Co. Ltd.; Active, not recruiting -> Completed ; Trial primary completion date: Apr 2015 ->Aug 2014

Trial completion • Trial primary completion date • Biosimilar

In Vitro and In Vivo Activity of Zabofloxacin and Other Fluoroquinolones Against MRSA Isolates from A University Hospital in Egypt. (PubMed, Pol J Microbiol) - "This study compares the in vitro and in vivo activities of zabofloxacin, a novel fluoroquinolone, with moxifloxacin, levofloxacin and ciprofloxacin against clinical isolates of MRSA from patients hospitalized in the Alexandria Main University hospital; a tertiary hospital in Alexandria, Egypt, where zabofloxacin has not been yet introduced. In conclusion, zabofloxacin was proved to possess high in vitro and in vivo efficacy encompassing its comparators and could be considered as a possible candidate for the treatment of infections caused by MRSA. To our knowledge, this is the first study evaluating the in vitro and in vivo activity of zabofloxacin against Egyptian MRSA clinical isolates."

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New antibiotics in infection treatment (PubMed, Pol Merkur Lekarski) - "...Ceftazidime with avibactam and ceftolozane with tazobactam show exceptional efficacy in severe infections. Karbavans is a combination of meropenem and a new boron beta-lactamase inhibitor, as well as the combination of avibactam and aztreonam, are a hope for the treatment of infections caused by Klebsiella pneumoniae resistant to the majority of available antibiotics. S649266 is itself an inhibitor of beta-lactamases...Solithromycin, a new ketolide, has immunomodulatory effects and a broad antiinflammatory spectrum, with no side effects caused by older generations of macrolides. New fluoroquinolones (delafloxacin, zabofloxacin, finefloxacin, nemonoxacin, zoliflodacin) show a wide spectrum of action with less and less side effects. The new MRX-1 preapplate, alongside tedizolid and cadazolid, are further oxazolidinones that show significant activity against multi-resistant Gram-positive pathogens. The presented palette of new molecules with antimicrobial activity will..."

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