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Presage Nabs Cancer Rx To Test In Its Drug Cocktail Injection System

Xconomy Seattle — 

Cancer is an elusive foe. Rarely does a single therapy or intervention knock it out, which is why drug combinations are at the top of the agenda for doctors and researchers, even as cutting-edge treatments such as the latest immunotherapies move the field forward.

Presage Biosciences of Seattle has created a way to test combinations of cancer drugs in live tumors. The firm is developing a device, bristling with tiny needles, which injects microscopic amounts of multiple drugs directly into tumors. Other firms, such as Celgene, have paid Presage millions of dollars to use the device for their own drug experiments.

Now Presage has its own drug to test. The company said Tuesday it has licensed voruciclib from the Indian firm Piramal Enterprises. It’s a type of drug known as a cyclin-dependent kinase inhibitor; earlier this year, Pfizer’s palbociclib (Ibrance) was the first of the type to be approved in the U.S.

Presage has been testing voruciclib quietly with its own technology, and the results were interesting enough to make a deal for its worldwide rights. (Terms were undisclosed.) Presage CEO Nathan Caffo said voruciclib is taken as a pill, which could be an advantage in cancer drug combinations, which often include therapies infused into the body during hospital visits. The company’s tests have already uncovered “unexpected activity,” Caffo said via email.

Presage aims to start clinical trials next year, he said. Before Presage licensed it, voruciclib was tested in three Phase 1 trials that demonstrated what Caffo described as a “solid safety profile and encouraging efficacy signals.”

As I wrote about in April, the company published work in Science Translational Medicine showing that its drug-testing system, dubbed CIVO, is on the right track.

The work is still early. For now CIVO only injects drugs into tumors accessible through the skin, such as skin and breast cancer and certain lymphomas. In its first human trial with the system, before it licensed voruciclib, the company dosed four lymphoma patients at the Fred Hutchinson Cancer Research Center in Seattle, where the CIVO technology originated.

The trial assessed CIVO’s safety and refined what Caffo calls the “choreography” of the system: “We have shown that we can assess responses to multiple different drug microdoses directly in a patient’s own tumor, but without exposing them to the levels of toxicity that almost always comes with systemic administration of cancer drugs.”

Safety is key. If the FDA is convinced that CIVO microinjections stay within the tumor and have no side effects on the patient, Presage would then aim to use the system with voruciclib, and perhaps drugs that haven’t yet entered clinical trials. The company meets with the FDA in January with hopes of starting two new trials soon after, one in lymphoma and one in an undisclosed indication, according to Caffo.