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ZielBio to Present Interim Findings from its Phase 1/2, First-in-Human Trial of ZB131 at 2023 ASCO Annual Meeting
ZB131 is a first-in-class humanized monoclonal antibody targeting cancer-specific plectin (CSP), which is expressed on the surface of cancer cells in solid tumors
Interim data demonstrates safety and tolerability of ZB131 while providing evidence of clinical activity in a proportion of patients with difficult-to-treat tumors
Charlottesville, Va., June 2, 2023 – ZielBio, Inc., a clinical stage biotechnology company discovering new treatments for cancer and other serious diseases, will present the first set of clinical data from its lead asset, ZB131, directed against cancer-specific plectin (CSP), during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. In an interim analysis (n=32) of the Phase 1/2 trial, ZB131 demonstrated a favorable safety and tolerability profile, evidence of clinical activity and dose-proportional pharmacokinetics.
Dr. David Sommerhalder, principal investigator at NEXT Oncology in San Antonio, Texas, will present the data in a poster session (board 281) on Saturday, June 3 from 9:00 am to 12:30 pm in poster Hall A at Chicago’s McCormick Place.
The ZB131 clinical trial (trial identifier NCT05074472) is a Phase 1/2, first-in-human, open-label, dose escalation study of ZB131 in tumors likely to express CSP. The primary objective of the dose escalation phase was to evaluate the safety and tolerability of ZB131 as a monotherapy. Having established safe dosing levels, the study began enrolling expansion cohorts treating patients with either ZB131 at 30 mg/kg as a monotherapy or ZB131 at 15 mg/kg in combination with gemcitabine.
“The initial safety, pharmacokinetics and clinical activity from the Phase 1/2 trial, combined with preclinical evidence that ZB131 binds selectively to CSP, rapidly internalizes, and can be conjugated to cytotoxic payloads, validates our efforts to further develop ZB131, including as an antibody-drug conjugate (ADC),” said Alan Bash, CEO of ZielBio. “CSP is a highly promising target given its cell surface expression in malignant tissue and lack of presence in healthy tissue across multiple solid tumors, and ZielBio is leading the field of research into this target.”
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 novel lead asset ZB131 (proposed international nonproprietary name Ibentatug), a proprietary humanized monoclonal antibody against cancer-specific plectin. The company’s clinical trial of ZB131 is open and enrolling with additional study details available at clinicaltrials.gov (NCT05074472).
Media Contact:
Sarah O’Connell
Verge Scientific Communications
ZielBio to Present New Research on the Utility of Cancer-Specific Plectin (CSP) and ZB131 in Antibody-Drug Conjugates at AACR Annual Meeting 2023
ZB131 is a first-in-class humanized monoclonal antibody targeting cancer-specific plectin (CSP), which is expressed on the surface of cancer cells in many solid tumors
New, preclinical research suggests that CSP is a promising target and ZB131 is an ideal candidate for antibody-drug conjugate approaches
Charlottesville, Va., April 17, 2023 – ZielBio, Inc., a clinical stage biotechnology company discovering new treatments for cancer and other serious diseases, will present new, preclinical data showing that its lead asset, ZB131, directed against cancer-specific plectin (CSP), represents a promising approach for antibody-drug conjugates (ADCs) at the American Association for Cancer Research (AACR) Annual Meeting 2023.
The AACR Annual Meeting is taking place April 14-19, 2023 in Orlando and virtually. ZielBio’s Dr. Lindsey Brinton, Principal Scientist and Head of Research, and Dr. Samantha Perez, Senior Scientist, will present the data in a poster session on Wednesday, April 19 from 9:00 am to 12:30 pm in Section 21 of the poster hall.
Major advances in payload and linker technology are increasing the clinical adoption of ADCs, leaving an unmet need for the identification of new targets that differentiate cancer cells from healthy cells across multiple tumor types. ZielBio has validated CSP, a pro-tumorigenic protein expressed on the surface of cancer cells, as a high-value drug target and developed ZB131 as a first-in-class anti-CSP monoclonal antibody. ZB131 is currently being evaluated in a Phase 1/2 clinical trial (NCT05074472) across multiple solid tumors.
Research presented at AACR will focus on CSP as a target for ADCs, demonstrating its abundance on the surface of cancer cells (and not healthy tissue), its bioavailability in humans, and its application across multiple cancer indications. ZB131 demonstrates favorable pharmacokinetics, is rapidly internalized by CSP-expressing tumor cells in mouse models, and can be conjugated to multiple cytotoxic payloads.
“These findings underscore our enthusiasm for CSP as a therapeutic target and ZB131 as an excellent candidate for conjugation to payloads,” said Alan Bash, CEO of ZielBio. “We are excited to share this data with the AACR community and are committed to exploring new avenues for deploying ZB131 against difficult-to-treat cancers.”
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 novel lead asset ZB131 (proposed international nonproprietary name Ibentatug), a proprietary humanized monoclonal antibody against cancer-specific plectin. The company’s clinical trial of ZB131 is open and enrolling with additional study details available at clinicaltrials.gov (NCT05074472).
Media Contact:
Sarah O’Connell
Verge Scientific Communications
ZielBio Appoints Alan Bash CEO as Company Advances Oncology Therapeutics
Phase 1/2 clinical trial of ZB131 to begin enrolling expansion cohorts in early 2023
Charlottesville, Va., January 3, 2023 – ZielBio, Inc., a clinical-stage biotechnology company discovering new treatments for cancer through its innovative drug discovery platform, has appointed Alan S. Bash as the company’s new Chief Executive Officer and member of the company’s Board of Directors.
The appointment of Mr. Bash comes as ZielBio reaches the completion of enrollment in the Phase 1, dose escalation, open-label study of lead asset ZB131 (proposed international nonproprietary name Ibentatug), a cancer specific plectin (CSP)-targeting functional antibody, in tumors likely to express CSP. The company plans to open Phase 2 expansion cohorts with ZB131 as monotherapy and in combination with a standard of care therapeutic in the first quarter of 2023.
“I am excited to work with Alan, continuing ZielBio’s mission to bring innovative therapeutics to patients,” said Dr. Kimberly Kelly, who will continue to serve ZielBio as President, Chief Operating Officer and member of the Board of Directors. “I am encouraged by the preliminary safety data from our clinical trial. With an expanding clinical program in several cancers with high unmet need on the horizon, Alan arrives at a pivotal time for our company.”
Dieter Weinand, Chairman of the Board of ZielBio said, “We are very pleased to welcome Alan to lead ZielBio through its next phase of growth. Alan’s demonstrated ability to develop and commercialize innovative treatments for cancer patients, combined with his experience in both large pharmaceutical and smaller biotechnology settings, will provide the strategic and operational expertise needed to help ZielBio reach its full potential.”
“ZielBio has demonstrated a unique capability to discover novel targets and has already brought a promising, highly differentiated antibody, ZB131, into the clinic,” said Mr. Bash. “I am honored to work alongside Kimberly Kelly and the entire ZielBio team, to help make a difference in the lives of patients with difficult-to-treat tumors.”
Mr. Bash most recently served as President and Chief Executive Officer of Checkmate Pharmaceuticals, a publicly traded clinical-stage oncology biotechnology company that was acquired by Regeneron Pharmaceuticals in May 2022. He joined Checkmate after a 22-year career at Bristol Myers Squibb (BMS), where he served as Senior Vice President, Commercial Model Innovation, and prior to that, Senior Vice President for Immunology and Fibrosis, partnering with Research & Development to advance early and late-stage assets in the integrated BMS and Celgene portfolios. During his years leading teams in oncology at BMS, he led the U.S. launch of the PD-1 checkpoint inhibitor, Opdivo®, and the first FDA-approved checkpoint combination. He also served as Worldwide Vice President for BMS’s lung cancer franchise and led the product team for a targeted antibody for head and neck cancer and colorectal cancer. He earned his BA from Georgetown University and his MBA from Columbia Business School.
About ZielBio, Inc.
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 novel lead asset ZB131 (proposed international nonproprietary name Ibentatug), a proprietary humanized monoclonal antibody against cancer specific plectin. The company’s clinical trial of ZB131 is open and enrolling with additional study details available at clinicaltrials.gov (NCT05074472).
Media Contact:
Sarah O’Connell
Verge Scientific Communications
ZielBio Receives Orphan Drug Designation for ZB131 for the Treatment of Pancreatic Cancer
A Phase 1/2 clinical trial of ZB131 is actively enrolling patients with advanced solid tumors
Charlottesville, Va., December 27, 2022 – ZielBio, Inc., a clinical-stage biotechnology company discovering new treatments for cancer and other serious diseases through its innovative drug discovery platform, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead program, ZB131, for the treatment of treatment of pancreatic cancer, a rare solid-tumor cancer originating from the pancreas. ZB131 is a proprietary 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, including pancreatic cancer. ZielBio previously received Orphan Drug Designation for ZB131 for the treatment of cholangiocarcinoma (bile duct cancer).
“More than 62,000 people in the United States are diagnosed with pancreatic cancer each year and the five-year survival rate is only 11%,” said Kimberly Kelly, Ph.D., founder and president of ZielBio. “We appreciate the special status that the FDA has granted ZB131 with this Orphan Drug Designation for pancreatic cancer, which is typically diagnosed at an advanced stage with few effective treatment options.”
ZielBio developed ZB131 to target CSP after discovering that, unlike in healthy cells where plectin exists in the cytoplasm, plectin presents on the surface of cancer cells, where it functions as a driver of tumor growth and metastasis. In preclinical studies, ZB131 demonstrated high specific binding to CSP and strong anti-cancer activity. A Phase 1/2 trial is underway to study the safety, tolerability, and efficacy of ZB131 in patients with solid tumors, including cholangiocarcinoma, pancreatic, and ovarian cancers. Additional study details are available at clinicaltrials.gov with the trial identifier NCT05074472.
FDA Orphan Drug Designation may be granted to investigational drugs or biological products which show promise in treating rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Certain benefits associated with Orphan Drug Designation encourage the continued development of medicines that bring novel solutions to underserved patients. Roughly 32,970 men and 29,240 women in the United States are diagnosed each year with pancreatic cancer.
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 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 novel lead asset ZB131 (proposed international nonproprietary name Ibentatug), a humanized monoclonal antibody against cancer-specific plectin.
Media Contact
Sarah O’Connell
Verge Scientific Communications
soconnell@vergescientific.com
