GSK’s First-in-Class Oral Antibiotic Blujepa Receives FDA Priority Review with 92.6% Cure Rate in Gonorrhea; Novartis’ Ianalumab Meets Primary Endpoints in Two Phase 3 Trials for Sjögren’s Disease

Over 92% Cure Rate! GSK's "First-in-Class" Small Molecule Granted Priority Review

GSK announced today that the U.S. FDA has accepted its supplemental New Drug Application (sNDA) for the oral antibiotic Blujepa (gepotidacin) for the treatment of uncomplicated urogenital gonorrhea in patients aged 12 years and older (weighing ≥45 kg), granting it Priority Review. The PDUFA date for this application is December 11, 2025.According to the press release, if approved, Blujepa will provide a new oral treatment option for this patient population, which currently mainly relies on injectable therapies.

This application is primarily based on the positive results of the Phase 3 EAGLE-1 clinical trial. Analysis shows,The urogenital cure rate for patients receiving oral Blujepa twice was 92.6% (187/202, 95% CI: 88.0-95.8), demonstrating non-inferiority compared to the cure rate of 91.2% (186/204, 95% CI: 86.4-94.7) for the regimen of intramuscular ceftriaxone combined with oral azithromycin.Neither group experienced Neisseria gonorrhoeae (N. gonorrhoeae) persistently leading to failure in the treatment of the urinary and reproductive tracts, with safety consistent with previous clinical outcomes; no serious drug-related adverse events were observed, and common adverse reactions were mild to moderate gastrointestinal reactions.

Blujepa is an oral "first-in-class" antibiotic with a unique mechanism of action. It can evenly inhibit two different type II topoisomerases, thereby exerting antibacterial activity against most target pathogens, including strains resistant to existing antibiotics. Due to its balanced inhibition of both enzymes, bacteria would need to develop mutations in both enzymes simultaneously to significantly reduce their susceptibility to Blujepa, making the likelihood of resistance development relatively low. In March this year, Blujepa was approved by the United States.FDA Approval, for the treatment of simple urinary tract infections (uUTI) in female adults and children aged 12 years and above (body weight ≥40 kg).

Potential First! Novartis Monoclonal Antibody Reaches Primary Endpoints in Two Phase 3 Trials

Novartis today announced positive results from the Phase 3 clinical trials NEPTUNUS-1 and NEPTUNUS-2 of its investigational monoclonal antibody ianalumab (VAY736) for the treatment of adult patients with active Sjögren’s disease (SjD). Both studies met their primary endpoints, achieving statistically significant reductions in disease activity.According to the press release, these two trials are the first global Phase 3 trials to show significant improvement in Sjögren's syndrome disease activity, and ianalumab is expected to become the first approved targeted therapy for Sjögren's syndrome.The study also showed that ianalumab was well tolerated, demonstrating an acceptable safety profile.

Ianalumab is a novel fully human monoclonal antibody with a dual mechanism of action—achieving B-cell depletion through antibody-dependent cellular cytotoxicity (ADCC) and blocking BAFF-R-mediated B-cell function and survival signals. This therapy is being developed for various B-cell-driven autoimmune diseases. In multiple clinical trials, ianalumab has demonstrated favorable efficacy and safety in indications such as Sjögren's syndrome, systemic lupus erythematosus, and immune thrombocytopenia. The drug originated from an early collaboration between Novartis and MorphoSys, the latter of which was acquired by Novartis in 2024.

Key Phase 3 Results of Cancer Vaccine Combination Therapy Announced, Preparing to Submit for Market Approval

IO Biotech Announces Primary Results from Pivotal Phase 3 Clinical Trial of Investigational Cancer Vaccine Cylembio (imsapepimut and etimupepimut with Adjuvant)IO Biotech announced today the primary results from the pivotal Phase 3 clinical trial of its investigational cancer vaccine, Cylembio (imsapepimut and etimupepimut, with adjuvant). The trial evaluated the efficacy of Cylembio in combination with MSD's PD-1 inhibitor Keytruda (pembrolizumab) compared to pembrolizumab monotherapy as a first-line treatment in 407 patients with unresectable or metastatic melanoma.

Analysis showsThe combination therapy group showed improvement in progression-free survival (PFS) compared to the monotherapy group, with a hazard ratio of 0.77 (95% CI: 0.58-1.00). The median PFS was 19.4 months versus 11.0 months, respectively., but the statistical significance of the primary endpoint (p=0.056) was slightly below the pre-specified threshold (p≤0.045). In the subgroup of patients who had not received neoadjuvant/adjuvant PD-1 inhibitor treatment (n=371), the hazard ratio for the combination therapy was 0.74 (95% CI: 0.56-0.98, p=0.037), with the median PFS extended to 24.8 months, compared to 11.0 months in the control group.PFS improvement was observed in almost all subgroups, with particularly significant benefit in patients with PD-L1-negative tumors (HR=0.54, 95% CI: 0.35-0.85, p=0.006), with a median PFS of 16.6 months compared to 3.0 months in the control group.The study also observed an improvement trend in overall survival (OS) for the combination therapy group (HR=0.79, 95% CI: 0.57-1.10), but the data is not yet mature. Cylembio combined with pembrolizumab was well-tolerated, with no new safety signals identified. IO Biotech plans to meet with the U.S. FDA this fall to discuss the study data and potential regulatory submission pathways.

Cylembio is an investigational immunomodulatory, off-the-shelf cancer therapeutic vaccine designed to activate and expand T cells targeting IDO1-positive and/or PD-L1-positive cells, aiming to simultaneously eliminate tumor cells and immunosuppressive cells in the tumor microenvironment.

References:

[1] Novartis announces both ianalumab Phase III clinical trials met primary endpoint in patients with Sjögren’s disease. Retrieved August 11, 2025 from  https://www.novartis.com/news/media-releases/novartis-announces-both-ianalumab-phase-iii-clinical-trials-met-primary-endpoint-patients-sjogrens-disease

[2] Gepotidacin accepted for priority review by the US FDA for the oral treatment of uncomplicated urogenital gonorrhoea. Retrieved August 11, 2025 from https://www.gsk.com/media/flmllaky/gepo-gc-us-filing-acceptance_sea_final.pdf

[3] IO Biotech Announces Clinical Improvement in Progression Free Survival Demonstrated in Pivotal Phase 3 Trial of Cylembio® plus KEYTRUDA® (Pembrolizumab) for the Treatment of First-line Advanced Melanoma, but Statistical Significance Narrowly Missed. Retrieved August 11, 2025 from https://iobiotech.com/press-releases/?workflow=6562e614-30a0-4300-9a37-ab75253933a2