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The majority of neoantigens arise from unique mutations that are not shared between individual patients, making neoantigen-directed immunotherapy a fully personalized treatment approach. Novel technical advances in next-generation sequencing of tumor samples and artificial intelligence (AI) allow fast and systematic prediction of tumor neoantigens. This study investigates feasibility, safety, immunity, and antitumor potential of the personalized peptide-based neoantigen vaccine, EVX-01, including the novel CD8+ T-cell inducing adjuvant, CAF®09b, in patients with metastatic melanoma (NTC03715985). The AI platform PIONEERTM was used for identification of tumor-derived neoantigens to be included in a peptide-based personalized therapeutic cancer vaccine. EVX-01 immunotherapy consisted of 6 administrations with 5-10 PIONEERTM-predicted neoantigens as synthetic peptides combined with the novel liposome-based Cationic Adjuvant Formulation 09b (CAF®09b) to strengthen T-cell responses. EVX-01 was combined with immune checkpoint inhibitors to augment the activity of EVX-01-induced immune responses. The primary endpoint was safety, exploratory endpoints included feasibility, immunologic and objective responses. This interim analysis reports the results from the first dose-level cohort of five patients. We documented a short vaccine manufacturing time of 48-55 days which enabled the initiation of EVX-01 treatment within 60 days from baseline biopsy. No severe adverse events were observed. EVX-01 elicited long-lasting EVX-01-specific T-cell responses in all patients. Competitive manufacturing time was demonstrated. EVX-01 was shown to be safe and able to elicit immune responses targeting tumor neoantigens with encouraging early indications of a clinical and meaningful antitumor efficacy, warranting further study. [ABSTRACT FROM AUTHOR]

Objective. This study aimed to evaluate the results of the Danish experience with the ProACT urinary continence device inserted in men with stress urinary incontinence. Material and methods. The ProACT was inserted in 114 patients. Data were registered prospectively. The main endpoints were complications, pad use per day and 24 h urinary leakage. A questionnaire evaluating symptoms and satisfaction was sent to the patients. Results. Data including preoperative and postoperative pad use and urinary leakage were available for 92 and 90 patients, respectively. A decrease in the median 24 h urinary leakage (352.5 vs 11 ml, p < 0.001) and in the median number of pads used per day (4.75 vs 2.25, p = 0.001) was demonstrated. Forty-six patients had a pad use of 0-1 pads per day and/or a daily urinary leakage less than 8 g, corresponding to an overall dry rate of 50%. A decrease in urinary leakage > 50% was seen in 72 patients (80%). Complications were seen in 23 patients. All of these were treated successfully by removal of the device in the outpatient setting followed by replacement of the device. Another eight patients had a third balloon inserted to improve continence further. Fourteen patients (12%) ended up with an artificial sphincter or a urethral sling. Sixty patients (63%) experienced no discomfort and 58 (61%) reported being dry or markedly improved. Overall, 50 patients (53%) reported being very or predominantly satisfied. Conclusions. Adjustable continence balloons seem to be a good alternative in the treatment of male urinary incontinence. Complications are mild and easily treated. [ABSTRACT FROM AUTHOR]

Irreversible damage of renal transplants may be prevented if insufficient graft perfusion can be detected perioperatively. Colour and spectral Doppler ultrasonography were performed in 30 consecutive renal transplants. The perfusion of the graft and the Resistive Index (RI) were evaluated perioperatively (perioperatively and less than 15 min postoperatively) and 24 h after the operation in all patients. In four cases (13.3%) RI > 0.9 was detected and immediate surgical correction of the cause led to a normalization (RI < 0.8) in all four cases. A RI < 0.9 required no intervention in 26 cases (86.7%). All renal grafts in this series were functioning 1 month postoperatively. In a comparative group, 30 consecutive transplants carried out at our institution without perioperative Doppler ultrasonography evaluation, a loss of four renal grafts perioperatively was recorded retrospectively. We conclude that perioperative ultrasonography Doppler evaluation may provide an easy applicable and reliable method for early detection of insufficient renal graft perfusion, allowing surgical correction before irreversible damage of the graft occurs. RI > 0.9 is pathological. A continuation of the study is required to clarify the long-term value of perioperative Doppler ultrasonography graft monitoring. [ABSTRACT FROM AUTHOR]

This report describes three cases of infection with Sphingobacterium multivorum after transrectal ultrasound-guided prostate biopsy. The pathogen is ubiquitous in water and soil but has been described fewer than 10 times causing infections in humans. An infection hygiene evaluation identified and changed a step in the biopsy process in order to reduce the risk of inoculating the patient with environmental microorganisms. [ABSTRACT FROM AUTHOR]