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VL-2397 Antifungal

VL-2397 is Vical’s novel antifungal compound that was licensed from Astellas Pharma in 2015. VL-2397 was isolated from a leaf litter fungus collected in a Malaysian national park and represents the first agent in a potentially new class of antifungal drugs. The FDA has granted Vical Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designations for VL-2397 in the treatment of invasive aspergillosis.

The investigational product is currently in a Phase 2 trial. The multicenter, open label randomized clinical study, will compare the efficacy and safety of VL-2397 to standard treatment for invasive aspergillosis in acute leukemia patients and recipients of allogeneic hematopoietic cell transplant (HCT).

The U.S. Food and Drug Administration (FDA) has advised that VL‑2397 would be eligible for a Limited Use Indication (LUI) assuming a successful outcome of a single Phase 2 trial carried out in accordance with a protocol and statistical analysis plan consistent with the Agency's advice. The final determination whether the drug is approvable will be made by FDA after review of all relevant data. The LUI is a provision of the Limited Population Pathway established under the 21st Century Cures Act of 2016.

The global Phase 2 trial is expected to enroll approximately 200 patients who will be randomized on a 2:1 basis with approximately 134 patients treated with VL-2397 and 66 patients treated with a standard 6-week course of their physician's choice of voriconazole, isavuconazole, or liposomal amphotericin B. The patients in the VL-2397 arm will receive daily treatment with VL-2397 for 4 weeks, followed by a 2-week course of physician’s choice of the comparator. The primary endpoint of the trial is all-cause mortality at 4 weeks and the key secondary endpoint is all-cause mortality at 6 weeks. The trial will be conducted at selected sites in North America, Europe and Asia.

Presentation at TIMM 2017

ID Week 2017

ASM Microbe 2017

ICAAC 2014

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