Presage's multiple-cancer-drug injection device shows promising first-in-human results

Presage's CIVO multiple-drug injection platform--Courtesy of Presage

Researchers at Seattle-based Presage Biosciences and the Fred Hutchinson Cancer Research Center have released results from a study showing further evidence their microinjection delivery device can accurately determine which cancer drugs are effective by testing multiple drugs at once inside a tumor.

Presage, a 2013 FierceBiotech Fierce 15 company, has had Celgene ($CELG) and Takeda subsidiary Millennium in its corner as early investors as it developed its platform for comparing the responses of anticancer drugs in tumors. Its CIVO system, besides helping determine a patient's best chance at a treatment regimen, could also give companies a preclinical leg up while enrolling clinical trials.

CIVO allows for the injection of microdoses of up to 10 combinations of cancer drugs into a tumor, where they stay for up to three days until a researcher measures the response of each of the drugs. The injection spans the full depth of the tumor, according to the company, in multiple columns that allow for a distinct analysis of each treatment.

In an ongoing first-in-human study, early data showed that patients with lymphoma injected with the cancer drug vincristine showed clear cell death in surrounding cells with no serious adverse events. The team published results in the journal Science Translational Medicine, with results from mice and dogs in addition to humans.

"This analysis creates a comprehensive portrait of drug response that has never been seen before this early in the drug development process," Presage Chief Scientific Officer Richard Klinghoffer said in a statement. "Using this technology, we can assess how drugs, both as single agents and in combinations, impact the biology of tumor cells in the context of the native tumor microenvironment. ... This sets the stage for a new type of pre-Phase I clinical study in which multiple drugs or drug combinations can be tested simultaneously, directly in a patient's own tumor, without toxicity associated with systemic drug delivery."

Researchers have used CIVO with more than 100 approved and investigational drugs, according to Presage.

"Currently, only 7% of new oncology drug candidates that demonstrated anti-cancer activity in preclinical studies subsequently demonstrate sufficient efficacy in clinical trials to warrant FDA approvals," Fred Hutch oncologist James Olson said. "... We developed CIVO because patients desperately need better approaches to identify treatments that will provide benefit and improve patient survival."

- here's the release
- read the editor's summary of the research article

Special Report: FierceBiotech's 2013 Fierce 15 - Presage Biosciences

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