Research agreement to support Phase 0 tumor microdosing studies
Seattle, WA /PRNewswire/ - Presage Biosciences, a cancer biotechnology company pioneering a new cancer drug development approach using its CIVO™ intratumoral microdosing platform, today announced it has entered into a research collaboration with Celgene Corporation to evaluate several of Celgene's early stage assets in Phase 0 trials. Presage's CIVO platform is used to evaluate patients' unique responses to microdoses of multiple cancer drugs.
"It is widely recognized that in vitro and animal models of cancer have failed to predict drug efficacy in cancer patients. With CIVO, we now have the opportunity to address this fundamental issue by directly evaluating each patient's individual response to multiple drug options," said Rich Klinghoffer, PhD, Presage CEO. "Celgene's early support enabled Presage to bring the CIVO platform from the laboratory setting into the clinic. We are very pleased to be collaborating again with Celgene to use CIVO in Phase 0 clinical trials."
In anticipation of expansion in offering Phase 0 services, Presage has hired Kirsten Anderson as its SVP of Clinical Development. Ms. Anderson has over 25 years of clinical drug development experience and clinical trial management with expertise in oncology.
"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 Ms. Anderson. "This approach offers truly novel acumen for oncology treatment that can help streamline drug development and offer targeted patient selection."
The collaboration with Celgene comes on the heels of Presage's recently completed clinical trial evaluating the safety and feasibility of utilizing the CIVO platform in sarcoma patients. The trial demonstrated that CIVO is well tolerated and highlighted drug-specific tumor cell and microenvironment responses to both small molecule and biologic agents. Presage expects to publish the results later this year.
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 (eIND) 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.
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.