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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:

Lissette Steele
Verge Scientific Communications
lsteele@vergescientific.com

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

Biotech veteran contributes extensive experience in clinical development and R&D

Company leadership expansion includes appointment of Ramesh K. Ramanathan as new vice president for clinical development

Charlottesville, Va. Jan. 20, 2022 – ZielBio, Inc., a clinical stage biotechnology company discovering new treatments for cancer and other serious diseases through its innovative ZielFind drug discovery platform, welcomes Maria Beconi, Ph.D., as the company’s chief science officer, and Ramesh Ramanathan, M.D., as vice president for clinical development.

Dr. Beconi brings more than 20 years of leadership experience to her new role, including supporting over 30 international regulatory submissions and registrations for both human and animal health drugs in multiple therapeutic areas and modalities. Dr. Ramanathan is a board-certified medical oncologist with more than 20 years of experience in new drug development.

“Maria and Ramesh’s combined expertise in research and development and clinical trials will further strengthen our team as we develop transformational therapies for patients suffering from serious diseases,” said Kimberly Kelly, Ph.D., founder and CEO of ZielBio. “Our expanded leadership team will provide critical guidance as we advance our lead candidate, ZB131, through the clinic.”

ZB131 is a proprietary humanized monoclonal antibody against cancer specific plectin (CSP), a target that is highly expressed on the plasma membrane of multiple types of cancer cells. With its ZielFind platform, ZielBio identified and validated CSP, revealing it as an actionable disease target. ZielBio has launched a multicenter study of ZB131, titled, “A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study of a Cancer-Specific Plectin (CSP)-Targeting Functional Antibody in Solid Tumors That Are Likely to Express CSP(NCT05074472).”

“I am honored to join the impressive and passionate ZielBio team to help advance the ZielFind target discovery platform and our pipeline of additional candidates in development,” said Dr. Beconi.

“The next few months will be pivotal as we recruit and treat patients in our first clinical study,” said Dr. Ramanathan.  

Prior to joining ZielBio, Dr. Beconi was a member of the senior leadership team at Disc Medicine and Goldfinch Bio, as well as the former chief scientific officer for Retrophin (now Travere Therapeutics), where she built the research and early development infrastructure and pipeline. She also hired and managed teams that, combined, resulted in the acquisition of three marketed products, licensing of one clinical stage compound, five orphan drug designations, four investigational new drug applications, and one successful End of Phase 2 trial. Before that, Dr. Beconi held leadership roles of increasing responsibility with the CHDI Foundation, Abbott Laboratories, Merck Research Labs, and Pharmacia & Upjohn. She was a key contributor to the elucidation of the mechanisms of toxicity of a chemical class of DPP-IV inhibitors, which led to the discovery of Sitagliptin. A native of Argentina, Dr. Beconi earned her doctorate in biochemistry from Michigan State University. She has authored and co‑authored over 50 peer-reviewed articles and meeting presentations.

Dr. Ramanathan most recently served as executive medical director of global medical and scientific affairs for Merck Research Labs. He also held prior academic appointments at the Phoenix campus of the Mayo Clinic, where he was professor of Medicine at the Mayo Medical School (now Mayo Clinic Alix School of Medicine) with a joint appointment at the Translational Genomics Research Institute (TGEN), Phoenix. Dr. Ramanathan has contributed to the development of several new drugs (PARP, PI3K inhibitors, hedgehog inhibitors, liposomal formulations, etc.) and had a pivotal role in development and approval of oxaliplatin and nab-paclitaxel. 

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 lead asset ZB131, a proprietary humanized monoclonal antibody against cancer specific plectin, a target identified through ZielFind.

Contacts

Tabatha Thompson
Verge Scientific Communications
tthompson@vergescientific.com

December 09, 2020 07:06 AM Eastern Standard Time

CHARLOTTESVILLE, Va.–(BUSINESS WIRE)–ZielBio, Inc., an early-stage biotechnology company discovering new treatments for cancer and other serious diseases through its innovative drug discovery platform, has appointed industry veteran Dieter Weinand as the company’s new Executive Chair.

“We are excited to welcome Dieter Weinand to our board in this vital stage where we are expanding our development programs and our outstanding scientific and corporate teams,” said Kimberly Kelly, PhD, Founder and President at ZielBio. “Dieter is a proven executive in life sciences and has embraced our mission to discover actionable, new disease targets and to use that knowledge to develop truly transformational therapies.” ZielBio’s lead candidate ZB131 is a proprietary humanized monoclonal antibody against cancer specific plectin (CSP), a target that is highly expressed on the plasma membrane of multiple types of cancer cells, including several with high unmet need. ZielBio plans to launch its first clinical trial of ZB131 in late 2021.

“I was attracted to ZielBio’s groundbreaking ZielFind target discovery platform,” said Mr. Weinand. “I look forward to working with the board and this impressive team to develop transformational therapies for patients suffering from serious diseases.”

Jason Dinges, JD, PhD, investment advisor to Morningside Ventures and ZielBio director, noted, “It is especially validating to have an executive of Dieter’s caliber join us in advancing ZielBio’s compelling technology. His wealth of experience will help guide our business efforts as we move our lead oncology asset ZB131 into the clinic in 2021 and accelerate our pipeline.”

Mr. Weinand joins ZielBio with deep expertise in the pharmaceutical industry, currently also serving as chairman of the board of directors of Replimune Group Inc., which completed an initial public offering in 2018 (NASDAQ: REPL). Previously, Mr. Weinand served as the Executive Vice President of Primary Care and was a member of the Executive Committee at Sanofi. Before moving to Sanofi, Mr. Weinand was CEO and Chairman of the Board of Management of Bayer Pharma AG and member of the Management Board at Bayer AG. Prior to his work at Sanofi, Mr. Weinand held positions of increasing responsibility at Pfizer, Bristol Myers Squibb, and Otsuka. He has raised several hundred million dollars for biotech companies and cultivated strategic alliances between Bayer and Loxo Oncology and between Pfizer and Bristol-Myers Squibb.

About ZielBio, Inc.

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 asset ZB131, a proprietary humanized monoclonal antibody against cancer specific plectin, a target identified through ZielFind.

Contacts

Susan Klees
Newberry Consulting for ZielBio
susanofcville@gmail.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