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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
ZielBio Receives Orphan Drug Designation for ZB131 for the Treatment of Cholangiocarcinoma
A Phase 1/2 clinical trial of ZB131 is actively enrolling patients with advanced solid tumors
Charlottesville, Va., November 15, 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 cholangiocarcinoma, a rare solid-tumor cancer originating from the bile duct system. 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.
“Patients suffering from cholangiocarcinoma have few promising therapeutic options,” said Kimberly Kelly, Ph.D., founder and CEO of ZielBio. “Receiving this Orphan Drug Designation is a regulatory milestone for ZielBio that validates our sustained efforts to bring new treatments to underserved patients.”
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. About 8,000 people in the United States are diagnosed each year with cholangiocarcinoma, including both intrahepatic (inside the liver) and extrahepatic (outside the liver) bile duct 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 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.
Media Contact
Sarah O’Connell
Verge Scientific Communications
ZielBio to Present New Data Demonstrating Preclinical Efficacy of ZB131 in Cholangiocarcinoma at AACR Annual Meeting 2022
ZB131 is a first-in-class humanized monoclonal antibody targeted to cancer specific plectin
New, preclinical research to be presented at AACR Annual Meeting 2022 shows ZB131 efficacy as a monotreatment for cholangiocarcinoma
Results also indicate dual treatment of ZB131 with standard-of-care chemotherapy gemcitabine enhances suppression of tumor growth above chemotherapy alone in cholangiocarcinoma
Charlottesville, Va., April 12, 2022 – ZielBio, Inc., a clinical stage biotechnology company discovering new treatments for cancer and other serious diseases through its innovative ZielFind drug discovery platform, will present new, preclinical data on the efficacy of its ZB131 drug in cholangiocarcinoma (CCA) models at the American Association for Cancer Research (AACR) Annual Meeting 2022. The conference will take place April 8-13, 2022 in New Orleans and virtually. Dr. Lindsey Brinton, Head of Discovery at ZielBio, will present the data in a talk on Tuesday, April 12 at 3:05 in La Nouvelle Orleans C.
The new preclinical research suggests that ZB131 is effective as a monotherapy in the treatment of CCA, a form of cancer which develops in the bile ducts. When used as a combination therapy with the standard-of-care chemotherapy drug, gemcitabine, ZB131 enhanced the chemotherapy’s anti-tumor effects.
CCA is a cancer with a high unmet need and a survival rate of <20% five years post-diagnosis. Most non-palliative patients relapse within two years and treatments in the advanced setting are limited. CCA tumors are characterized by high expression (>85%) of cancer specific plectin (CSP).
CSP is a pro-tumorigenic protein exclusively expressed on the surface of cancer cells. The common presence of CSP on the surface of CCA cells suggests that anti-CSP therapy may be effective in treating this form of cancer. ZB131 is a first-in-class humanized monoclonal antibody with a high affinity to and specificity for CSP.
In this study, ZB131 was administered as a monotherapy to mice inoculated with human CCA cells (CCA-xenografted mice). ZB131 significantly suppressed tumor growth in the majority of mice, and caused complete regression in 17% of mice. In another group of CCA-xenografted mice, ZB131 was administered in combination with the chemotherapy drug gemcitabine (100 mg/kg). In this group, ZB131 showed an increased tumor response (91% suppression) when compared to gemcitabine alone (74% suppression).
“These findings further confirm that ZB131, currently in Phase 1 clinical trials, presents an exciting possibility for the treatment of CCA and other CSP-positive cancers,” said Dr. Kimberly Kelly, CEO of ZielBio. “ZB131 has shown strong antitumor activity in vitro and in mouse models. Additionally, it has demonstrated an excellent safety profile with no toxicities identified in GLP-enabling toxicology studies in non-human primates. We are eager to present these data with the AACR community and to see what new data arises from our current Phase 1 clinical trial of ZB131.”
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 targets and therapies, including lead asset ZB131, a proprietary humanized monoclonal antibody against cancer specific plectin, a target identified through ZielFind.
Media Contact:
Sarah O’Connell
Verge Scientific Communications
soconnell@vergescientific.com
