On July 28, 2023 CYTEA BIO reported that it has taken a significant step towards addressing the urgent medical need for effective glioblastoma multiforme (GBM) treatments (Press release, CYTEA BIO, JUL 28, 2023, View Source [SID1234633480]). The company has submitted Briefing Documents to both European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) regulatory bodies seeking advice for the completion of pre-clinical and manufacturing development of the company’s first oncology treatment for glioblastoma multiforme, based on the proprietary PinTM platform, utilizing monoclonal antibody-armed Natural Killer (NK) effector cells.

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This advice will enable completion of pre-clinical studies and chemistry, manufacturing and control (CMC) development to position CYTEA|BIO to enroll first patients in a clinical study in 2025.

GBM, the most aggressive form of brain cancer, remains a devastating pathology with alarmingly poor patient prognosis. With the average age at diagnosis being less than 60 years and average survival rates extending for barely one year from diagnosis, there is an urgent and pressing need for novel and innovative therapies to help manage this life-threatening disease.