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ZielBio Announces First Patient Dosed in Phase 1/2 Clinical Trial of ZB131, Its Novel Monoclonal Antibody Targeting Cancer Specific Plectin

First-in-human, open-label, dose escalation study will evaluate ZB131 in patients who have solid tumors with high CSP expression ZB131 clinical trial open and enrolling patients

CHARLOTTESVILLE, Va./PRNewswire/ — ZielBio, Inc., a clinical stage biotechnology company discovering new treatments for cancer through its innovative ZielFind drug discovery platform, today announced the first patient dosed in its Phase 1/2 clinical trial. The study will evaluate ZB131 in patients with solid tumors who are either non-responsive to or ineligible for the standard of care. ZB131 is a monoclonal antibody with a high affinity and specificity for cancer specific plectin (CSP), a cell surface protein identified in a wide range of cancers that correlates with poor prognosis and aggressive tumors.

“Having the first patient dosed in the ZB131 trial represents an important milestone for the company and for unserved patients, including those with cholangiocarcinoma, pancreatic, and ovarian cancers,” said Kimberly Kelly, Ph.D., founder and CEO of ZielBio. “These types of cancers are difficult to treat with current therapies, but preclinical research suggests that ZB131 is able to bind to CSP located on the surface of cancer cells, resulting in profound tumor regression.”

The ZB131 clinical trial is a Phase 1/2, first-in-human, open-label, dose escalation study of a CSP-targeting functional antibody (ZB131) in tumors likely to express CSP. The primary objective of the Phase 1 dose escalation is to evaluate the safety and tolerability of ZB131 as a monotherapy. Once the recommended Phase 2 dose (RP2D) has been established, the dose expansion stage of the trial will begin enrolling patients to receive ZB131 in at least three pre-defined cohorts in cholangiocarcinoma, pancreatic, and ovarian cancers. The clinical trial is open and enrolling with additional study details available at clinicaltrials.gov with the trial identifier NCT05074472.

“The beginning of our clinical trial is an important step toward our goal of designing and offering safer, better therapies for patients who need them,” said Brian Schwartz, MD, and CMO of ZielBio. “By identifying new targets for treatment, we are expanding what is possible for the future of patient care and delivering new hope to a group of individuals who have not responded to or qualified for treatments previously.”

“CSP represents one out of countless novel cancer targets, many of which remain undiscovered,” said Dr. Kelly. “With ZielFind, we have the ability to bring forth the next evolution in target identification by interrogating cell proteins in their native context. This leads us to actionable targets and in turn, better therapies for unserved patients.”

Read more here.

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