Presage Receives FDA Clearance of First IND Application for Trial to Evaluate Investigational Oncology Agents with CIVO™ Technology

Friday, January 10, 2020

Presage Biosciences, a biotechnology company pioneering a new cancer drug development approach using its CIVO®  intratumoral microdosing platform, announced today that 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 Pharmaceutical Company Limited (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 has previously partnered with Presage on preclinical mechanism of action and combination studies, including work highlighted by both companies at AACR last year.  "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."

"Takeda's ongoing collaboration and support has enabled Presage to bring the CIVO platform into the clinic. We are very excited for this first trial to begin and demonstrate the possibilities for improving how oncology drug candidates are evaluated," added Klinghoffer.

Earlier this year, Presage announced collaborations with Celgene and BMS for Phase 0 trials with CIVO. Those trials are expected to commence in 2020 following FDA clearance. A recently completed clinical trial to evaluate the safety and feasibility of utilizing the CIVO platform demonstrated that CIVO is well tolerated and highlighted drug-specific tumor cell and microenvironment responses to both small molecule and biologic agents.

About CIVO and Phase 0 Trials

To address the challenges inherent in cancer drug discovery, Presage is advancing a new approach to rapidly evaluate multiple drug candidates and enhance knowledge applicable for future trial design. Exploratory Investigational New Drug studies, also known as Phase 0 trials, allow for the evaluation of minute amounts of drugs in patients to assess pharmacodynamic effects. CIVO is a patented platform that enables intratumoral microdosing and analysis of multiple cancer agents.

About Presage

Presage Biosciences is an oncology company pioneering a new drug development approach to assess novel therapeutics and combinations directly in human tumors with its patented CIVO™ intratumoral microdosing platform. The CIVO platform is intended to enable simultaneous assessment of responses to multiple drugs or drug combinations directly in a single tumor while still in a patient's body. Presage also partners with oncology-focused pharmaceutical companies through strategic alliances to provide preclinical data to discover effective drug combinations. Presage is privately held and based in Seattle. For more information, visit www.presagebio.com.

Media Contact:
Julie Rathbun
Rathbun Communications
(206) 769-9219
[email protected]