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Cancer treatment with KU origins enters second clinical trial

Tuesday, February 03, 2015

LAWRENCE — A potential cancer treatment with ties to the University of Kansas has entered its second clinical trial in the past four months.

Biopharmaceutical company Cleave Biosciences has begun a Phase 1 clinical trial to evaluate CB-5083, its top drug candidate in patients with advanced solid tumors. CB-5083 is derived from a compound initially synthesized by KU’s Specialized Chemistry Center.

CB-5083 is an oral inhibitor of p97, a critical enzyme that controls various aspects of protein homeostasis. The clinical trial will evaluate CB-5083 in patients with advanced solid tumors who have progressed, are nonresponsive to available therapies or for whom no standard therapy exists.

The announcement comes on the heels of Cleave’s announcement in September 2014 that it had begun a Phase 1 clinical trial to evaluate CB-5083 in patients with relapsed and refractory multiple myeloma.

“As scientists, our goal is to conduct research that translates to new therapies and cures for patients, particularly those who aren’t benefiting from current treatment options,” said Frank Schoenen, associate director of the SCC. “We’re proud that our lab helped develop the molecule from which this promising new treatment is derived, and we look forward to seeing how CB-5083 progresses, both in the relapsed and refractory multiple myeloma clinical trial announced a few months ago, and in the new trial involving patients with solid tumors.”

Cleave expects to enroll up to 75 patients at multiple U.S. cancer centers.

“Small molecules have proven important to researchers to explore biological function at the molecular, cellular and in vivo level,” Schoenen said. “These molecules have also been proven valuable for treating diseases, and most medicines marketed today are from this class. A key challenge is to identify small molecules effective at selectively modulating a given biological process or disease state. That’s a big part of what we’re doing at the SCC and at the University of Kansas.”

In addition to KU, Cleave Bioscience’s discovery partners include researchers from the California Institute of Technology and The Scripps Research Institute.

The SCC plays a prominent role in KU’s drug discovery efforts. The center is a member of the NIH’s Molecular Libraries Program, an elite group of five centers nationally whose aim is generate novel small-molecule probes by performing high-throughput screening, secondary screens and medicinal chemistry. The center is directed by Jeff Aubé, University Distinguished Professor in the Department of Medicinal Chemistry.

Additionally, the SCC is a key component of KU’s proposed Drug and Vaccine Development Institute. The institute would focus on the prevention and treatment of diseases and have two sub-institutes: the Institute for Translational Chemical Biology, which would focus on the creation of small-molecule drugs to treat emerging and rare diseases; and the Kansas Vaccine Institute, which was established last summer and would work on early-stage vaccine discoveries for preventing disease.


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