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Zentalis Pharmaceuticals Announces First Patient Dosed in the Potentially Registrational Phase 1/2 Study of BCL-2 inhibitor ZN-d5 in Patients with Relapsed or Refractory Light Chain (AL) Amyloidosis
NEW YORK and SAN DIEGO, March 22, 2022 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused
About this update from Zentalis Pharmaceuticals, Inc.
[{"type":"text","content":"NEW YORK and SAN DIEGO, March 22, 2022 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, today announced that the first patient has been dosed in the potentially registrational Phase 1/2 trial of ZN-d5, the Company’s oral selective BCL-2 inhibitor candidate for hematologic malignances and related disorders, in patients with relapsed or refractory light chain (AL) amyloidosis. “Initiating our first potentially registrational trial with ZN-d5 underscores our commitment to expanding the clinical exploration of our BCL-2 inhibitor, while also showcasing this candidate’s promise in treating this rare hematological disease,” commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. “AL amyloidosis is a life-threatening condition marked by progressive damage to a patient’s organs, and with limited therapeutic options available, additional therapies are urgently needed to treat advanced stage amyloidosis. BCL-2 is a validated target for plasma cell diseases and though preliminary, BCL-2 inhibitors have demonstrated meaningful activity in AL amyloidosis. Based on ZN-d5’s optimized, selective design, we believe our potentially best-in-class treatment may have the ability to help manage this devastating disease in the thousands of patients affected globally.” The Phase 1/2 trial (ZN-d5-003) is a global, single arm, open-label study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ZN-d5 in patients with AL amyloidosis. ZN-d5 will be administered orally, once daily on days 1-28, with cycles repeating every 28 days in the absence of disease progression or unacceptable toxicity. The Phase 1 dose-escalation portion of the trial will determine the maximum tolerated dose, the dose-limiting toxicities, and recommended Phase 2 dose. The Phase 2, two-stage portion will assess the efficacy of ZN-d5 in patients both t(11:14)-positive and -negative as measured by the objective response rate. More information about the trial is available at www.clinicaltrials.gov: NCT05199337. About Relapsed or Refractory Light Chain (AL) Amyloidosis AL amyloidosis, a rare disorder affecting ~75,000 people worldwide, is caused by the a...