Presage Receives FDA Clearance of First IND Application for CIVO Technology

Presage Biosciences announced the U.S. Food and Drug Administration (FDA) has approved its first Exploratory Investigational New Drug (IND) application for a Phase 0 study utilizing its CIVO platform. The study, which will employ the CIVO platform to evaluate patients' unique responses to microdoses of cancer drugs, is a collaboration with Takeda, with initiation planned in the first half of 2020.

"The green light from the FDA for Presage's first exploratory IND represents a major milestone as we seek to revolutionize early drug development through a superior approach to translational oncology," said Rich Klinghoffer, PhD, Presage CEO. "This latest success reflects our measured approach to building a long-term relationship with the FDA that will support our business model of making Phase 0 trials widely available to companies looking to gain deeper understanding of investigational drug response within the tumor microenvironment."

"Takeda's preclinical collaborations with Presage have been foundational to the honing of our translational insights into novel immuno-oncology agents," said Chris Arendt, Head, Oncology Therapeutic Area Unit, Takeda. "We are excited to now leverage the CIVO platform in the clinic and we are eager to see what insights this trial can provide and if intratumoral microdosing can enable biomarker studies that enrich and accelerate clinical translation."

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