HOOK - HOOKIPA wins FDA nod to start clinical studies for prostate cancer therapy

• Clinical-stage biotech HOOKIPA Pharma ( NASDAQ: HOOK ) announced on Monday that the FDA accepted its Investigational New Drug (IND) application for HB-300, an experimental therapy for metastatic castration-resistant prostate cancer. A Phase 1/2 trial for the treatment is expected to start by early next year.
• “FDA acceptance of our IND application for HB-300 is a key milestone as we expand and diversify our oncology pipeline and arenavirus platform from viral antigens to self-antigens,” Chief Executive Joern Aldag remarked.
• HB-300 is identified as an arenaviral immunotherapy designed to target two well-established antigens of prostate cancer, PAP and PSA.
• Parallelly, HOOKIPA ( HOOK ) announced that the FDA accepted the Drug Master File (DMF) to support the future submission of data specific to its replicating arenavirus platform.
• With the concurrent acceptance of DMF, “we have reduced cycle time between completion of preclinical studies and clinical entry of our pipeline projects,” Aldag added.
• Read: In April, HOOKIPA ( HOOK ) announced pre-clinical data supporting the potential of its arenaviral platform against various cancers.

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