Celgene taps Presage's microdosing tech for phase 0 cancer studies

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The FDA introduced the idea of phase 0 trials in 2006 in an attempt to bridge preclinical and clinical work and head off costly discoveries in the clinic that a drug doesn’t work as expected. (rawpixel/Pixabay)

After teaming up with Presage Biosciences on preclinical cancer models and pitching into its series D financing, Celgene is at it again. This time, the Big Biotech is signing a research deal around Presage’s technology that injects tiny doses of experimental drugs directly into solid tumors. Celgene will use it to evaluate early-stage candidates in phase 0 trials—that's right, phase 0.

The platform, called CIVO, is designed to assess patients’ unique response to microdoses of multiple cancer drugs. It is Presage’s solution to a fundamental problem in cancer drug development—the failure of preclinical animal models to accurately predict how drugs will perform in humans. Because mouse data are not a perfect predictor, the most promising of prospects can still falter in phase 1, costing time and money. 

The FDA introduced the idea of phase 0 trials in 2006 in an attempt to bridge preclinical and clinical work and head off costly discoveries in the clinic that a drug doesn’t work as expected. Instead of delivering small amounts of a drug systemically—as is typical with other phase 0 studies—CIVO delivers one or more candidates into part of a solid tumor. The technology creates columns of multiple fluorescent drugs that interact with tumor cells for one to three days. After that, the treated part of the tumor is removed for analysis. 

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RELATED: Celgene, Takeda invest in intratumoral microdosing firm Presage 

“Presage’s CIVO platform allows us to rapidly assess the effect of early pipeline agents and drug combinations with the potential for actionable insights from the tumor microenvironment,” said Kirsten Anderson, Presage’s newly hired senior vice president of clinical development, in a statement. “This approach offers truly novel acumen for oncology treatment that can help streamline drug development and offer targeted patient selection.” 

Celgene initially teamed up with Seattle-based Presage in 2013, and, along with Takeda—another early partner of Presage—contributed to the company’s $6 million series D round last July. The first agreement, centered on preclinical models of cancer, “enabled Presage to build toward the Phase 0 offering they are focused on today,” said Presage CEO Rich Klinghoffer, Ph.D., via email. 

Though Presage has experience carrying out phase 0 trials with CIVO, this is the first time the company will do so as part of an announced partnership, Klinghoffer said. 

“Presage is in active discussions at various stages with other potential collaborators to offer Phase 0 studies with CIVO,” he said. 

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