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Zentalis Pharmaceuticals Announces FDA Clearance of the IND for Its Third Oncology Drug Candidate, ZN-c3, a WEE1 Inhibitor, and the Dosing of the First Patient in a Phase 1/2 Clinical Trial

December 18, 2019 GMT

NEW YORK & SAN DIEGO--(BUSINESS WIRE)--Dec 18, 2019--

Zentalis Pharmaceuticals (the “Company” or “Zentalis”), a clinical-stage biopharmaceutical company focused on developing clinically differentiated, novel small molecule therapeutics that target fundamental pathways in cancer, today announced that the U.S. Food and Drug Administration (FDA) has previously cleared its Investigational New Drug (IND) application for its third oncology drug candidate, ZN-c3, and that it has dosed the first patient in a Phase 1/2 clinical trial evaluating ZN-c3 in patients with advanced solid tumors.

The Company is developing ZN-c3, an oral small molecule DNA Damage Response (DDR) drug candidate targeting WEE1 in cancer settings. WEE1 is a protein tyrosine kinase that regulates the cell cycle by serving as a checkpoint preventing DNA replication in the presence of DNA damage. The inhibition of WEE1 aims to generate sufficient DNA damage in cancer cells to cause them to undergo a programmed cell death called apoptosis, thereby preventing tumor growth. The Company has applied its medicinal chemistry expertise to design and synthesize its oral, small molecule compound, ZN-c3, with a potentially best-in-class product profile, including good solubility, selectivity and pharmacokinetic properties. We believe these characteristics will provide for a differentiated drug product to help fight cancer, if ZN-c3 is approved.

There is currently no FDA-approved WEE1 inhibitor. The Company is evaluating the potential of ZN-c3 in a Phase 1/2 clinical trial as monotherapy and in combination with an FDA-approved PARP inhibitor. As of December 16, 2019, the Company has enrolled two patients in this clinical trial. The Company expects to report preliminary data from this clinical trial in 2021.

“We are excited about targeting WEE1 because of its potential for potent anti-tumor activity across multiple cancer types,” said Dr. Kevin Bunker, Chief Operating Officer at Zentalis Pharmaceuticals. “ZN-c3 is an internally developed drug candidate that was designed to be a best-in-class molecule with optimized selectivity, great oral bioavailability, and tolerability. We believe these characteristics will provide significant clinical benefit for cancer patients.”

About Zentalis Pharmaceuticals

Zentalis Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing clinically differentiated, novel small molecule therapeutics that target fundamental biological pathways in cancer. In addition to its lead program, ZN-c5, an oral SERD for estrogen receptor positive, HER2-negative breast cancer, the Company is developing a broad pipeline of oncology candidates, targeting areas of major unmet medical need. The Company has offices in New York and San Diego. For more information, please visit www.zentalis.com.

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CONTACT: Investors:

Thomas Hoffmann

investors@zentalis.comMedia:

communications@zentalis.com

KEYWORD: CALIFORNIA NEW YORK UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: RESEARCH FDA CLINICAL TRIALS BIOTECHNOLOGY HEALTH GENERAL HEALTH OTHER SCIENCE SCIENCE ONCOLOGY

SOURCE: Zentalis Pharmaceuticals

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PUB: 12/18/2019 08:00 AM/DISC: 12/18/2019 08:00 AM

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