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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., Feb. 15, 2022 – 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.”

About ZielBio

ZielBio is a clinical stage biotechnology company that identifies novel disease targets and develops therapeutic interventions to improve patient outcomes. Its proprietary drug discovery platform, ZielFind, combines the power of functional, high throughput screening with large content data analytics to identify high value targets. ZielBio has a promising pipeline of therapies and targets, including lead asset ZB131, a proprietary humanized monoclonal antibody against cancer specific plectin, a target identified through ZielFind.

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Media Contact

Tabatha Thompson
Verge Scientific Communications
tthompson@vergescientific.com

Funding to Enable Development of Monoclonal Antibody ZB131

September 26, 2019 08:05 AM Eastern Daylight Time

CHARLOTTESVILLE, Va.–(BUSINESS WIRE)–ZielBio, Inc., an early-stage biotechnology company that identifies novel high value disease targets and develops therapeutic interventions to improve patient outcomes, has closed a $25.1 million Series A financing round. The round is led by Morningside Venture Investments and Partners Innovation Fund (PIF). ZielBio’s lead candidate ZB131 is a proprietary humanized monoclonal antibody against cell surface plectin (CSP), a target that is highly expressed on the plasma membrane of multiple types of cancer cells, including ovarian, pancreatic, lung and colorectal. The funding will enable the company to conduct further research to prioritize potential cancer applications, validate additional targets and initiate a planned phase 1 clinical trial with ZB131. “We are excited to partner with Morningside and PIF whose resources and drug development experience will greatly accelerate ZB131 development,” noted Kimberly Kelly, PhD, President and Chief Science Officer at ZielBio.

“Since its first discovery by ZielBio founder Dr. Kimberly Kelly at Massachusetts General Hospital, we have been encouraged by the unique role that cell surface plectin plays in proliferation, migration and cell survival and its potential as a drug target for a range of difficult to treat cancers,” said PIF Partner Meredith Fisher, PhD. “Extensive pre-clinical laboratory and animal research has demonstrated that ZB131 has a high affinity to bind to CSP, inducing growth arrest and necrosis of targeted tumor cells.”

“Despite the incredible progress being made in immuno-oncology, current therapies have limits and there remains a profound need for new targets and options for many deadly cancers,” said Jason Dinges, JD, PhD, Investment Advisor at Morningside Technology Advisory. “ZB131 has shown potentially superior immune activation to current checkpoint inhibitors and greater direct tumor cell killing than EGFR inhibitors.”

In connection with the financing, Drs. Dinges and Fisher have joined Dr. Kelly on the ZielBio Board of Directors.

About ZielBio

ZielBio is an early-stage biotechnology company that identifies novel disease targets and develops therapeutic interventions to improve patient outcomes. Its proprietary drug discovery platform Zielfind™ combines the power of functional, high throughput screening with large content data analytics to identify high value targets. ZielBio has a promising pipeline of therapies and targets, including lead compound ZB131, a proprietary humanized monoclonal antibody against cell surface plectin (CSP), a cancer target identified through Zielfind™.

Contacts

Susan Klees
Newberry Consulting
susanofcville@gmail.com
(434) 466-8930