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pp-145

Solution for infusion

Dossier type
CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: BCG-unresponsive NMIBC (FDA approved with BCG, 2024); Phase 3 expansion: NSCLC, colorectal, head and neck Clinical stage: Approved (NMIBC) + Phase 3 solid tumour expansion Modality: Biologic (IL-15/IL-15Rα-Fc fusion superagonist complex) Mechanism / Target: IL-15 superagonist — activates NK cells and CD8+ memory T cells without Treg expansion; trans-presents IL-15 via IL-15Rα for superior potency vs IL-15 monomer Route / form: Intravesical instillation (bladder); intravenous infusion (systemic tumours) Differentiation: First-approved IL-15 agent; avoids Treg-stimulating IL-2 effects; broad combinability with checkpoint inhibitors; proven activity in bladder cancer with intravesical delivery
Manufacturer #39176

Commercial-stage immuno-oncology company with an FDA-approved IL-15 superagonist. Expands approved asset into multiple solid tumour indications with wholly owned Phase 3 studies. Integrated manufacturing and commercialisation infrastructure in oncology.
 

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