Merck taps tumor-microdosing Presage Biosciences for phase 0 trials

Merck taps tumor-microdosing Presage Biosciences for phase 0 trials

Presage Biosciences landed two more biopharma partners in Merck and Maverick Therapeutics and raised another $13 million to expand its tumor microdosing technology. Its new partners will use that tech to assess new anti-cancer medicines in phase 0 trials, a stage in drug development designed to bridge preclinical and clinical work.

Of the financing, $6 million comes from new investors LabCorp Venture Fund, Bristol Myers Squibb—one of Presage’s pharma partners—and InHarv Partners. The remaining $6 million comes from Takeda Ventures, which is turning a convertible note into equity.

The funds will bankroll the expansion of Presage’s clinical sites in the U.S. and Australia, as well as the development of new devices for its microdosing technology, known as Comparative In Vivo Oncology, or CIVO for short.

Presage and its partners are using the CIVO technology for phase 0 studies, an idea the FDA introduced in 2006 to address the failure of animal models to accurately predict how drugs will work in humans. This approach involves injecting people with microdoses of the experimental drug—about 1/100 of the anticipated effective dose, said Presage CEO Rich Klinghoffer, Ph.D., in a previous interview. But administering tiny doses systemically can make it difficult to measure efficacy.

The CIVO platform is designed to deliver up to eight different microdoses of drugs or drug combinations directly into the tumor. Each drug or combination is injected alongside fluorescent tracking microspheres, which allow investigators to track each dose. This way, the tiny doses don’t disperse into the body, and investigators know exactly where in the tumor each drug was injected and where it went after that.

Presage is working on new devices for the CIVO platform so it can move into “a wider spectrum of cancers,” the company said in a statement.

Merck and Maverick, a biotech working on targeted immunotherapies, bring Presage’s partnerships to five. The others include Takeda, which signed on in September 2020, and Bristol Myers Squibb and Celgene, which have become one since they independently teamed up with Presage in 2019.

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