Presage and BMS Collaborate on Phase 0 Oncology Trials

Despite the slow pace of its acquisition of Celgene, Bristol-Myers Squibb continues to build out its network of companies it collaborates with on the development of potential oncology treatments.

Despite the slow pace of its acquisition of Celgene, Bristol-Myers Squibb continues to build out its network of companies it collaborates with on the development of potential oncology treatments.

This morning, BMS and Seattle-based Presage Biosciences announced a research collaboration for early-stage oncology targets in Phase 0 trials using Presage’s CIVO platform, which is used to evaluate patients’ unique responses to microdoses of multiple cancer drugs.

The CIVO platform was designed to assess the biology of tumor responses to “perturbation by microdoses” of different drugs and drug combinations. In other words, the technology allows developers to test drugs on tumors without having to do so in multiple clinical trials. The company’s tool has become a popular choice for some companies to use to 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. The CIVO platform Phase 0 studies use minute amounts of experimental drugs to assess pharmacodynamics effects in patients. The use of the platform reduces toxicity concerns in traditional Phase I trials, as intratumoral microdosing uses approximately 100-fold lower doses of drug candidates.

Financial terms of the deal were not disclosed. The collaboration with BMS is the third program Presage has struck that uses the CIVO platform to investigate tumor cell and microenvironment responses to investigational agents in a Phase 0 clinical trial. Earlier this year, the company entered into a deal with Celgene, the same company that BMS snapped up in a $74 billion deal earlier this year. Last year, Presage and Codiak BioSciences entered into a similar collaboration agreement.

Rich Klinghoffer, chief executive officer of Presage, said he was pleased to expand the use of CIVO technology in Phase 0 trials with BMS. With CIVO, Klinghoffer said, the companies are able to “directly evaluate responses to multiple drugs and combinations within a single tumor,” which provides a significant amount of information much earlier in the drug development process. Klinghoffer said that helps reduce risk and helps accelerate the timeline of drug development.

“This collaboration may provide important insights about how our compounds work mechanistically in combination studies and help us bring forward more effective options for patients with cancer,” Jonathan Leith, head of clinical mechanisms at BMS said in a statement. “At Bristol-Myers Squibb, we are seeking a more precise understanding of how treatments impact each patient to help inform tailored therapeutic strategies that will offer the greatest possible benefit.”

Last year, Takeda Pharmaceutical and Celgene invested $6 million into Presage to support the CIVO program.

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