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
Zentalis Pharmaceuticals (Nasdaq: ZNTL) announced the dosing of its first patient in a Phase 1/2 trial for ZN-d5, an oral selective BCL-2 inhibitor, targeting relapsed or refractory light chain (AL) amyloidosis. This trial (ZN-d5-003) aims to evaluate the safety, efficacy, and pharmacokinetics of ZN-d5 in patients with this rare and life-threatening condition. AL amyloidosis affects ~75,000 people globally, causing severe organ damage with limited treatment options. Zentalis aims to provide a potentially best-in-class therapy to address this unmet need.
- Initiation of Phase 1/2 trial for ZN-d5 indicates strong commitment to expanding clinical research.
- ZN-d5 targets a rare and serious condition with a significant unmet medical need.
- The trial will evaluate both safety and efficacy, which may lead to important therapeutic advancements.
- AL amyloidosis has limited existing treatment options, indicating a challenging market environment.
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 accumulation of abnormal antibodies, called immunoglobulin light chains. These abnormal proteins misfold and bind together to form amyloids, which deposit in organs. As the amyloids accumulate in organs – most commonly in the heart and kidneys – it causes widespread organ damage, resulting in high morbidity and mortality rates. While this is not a type of cancer, it is currently treated like one and patients receive agents active in multiple myeloma. However, existing therapies are not curative and ineffectively control the disease in many patients.
About ZN-d5
ZN-d5 is an oral inhibitor of B-cell lymphoma 2 (BCL-2) in development initially for the treatment of hematologic malignancies and related disorders. BCL-2 and BCL-xL are proteins that play a critical role in the regulation of cell death. The overexpression of BCL-2 and/or BCL-xL are frequently detected in numerous cancer types, which prevent apoptosis of cancer cells. Zentalis believes a BCL-2 inhibitor will restore the normal apoptosis process, making it an important target for cancer treatments. ZN-d5 is being evaluated in a Phase 1 trial in patients with AML and Non-Hodgkin’s lymphoma (NHL) as well as a potentially registrational Phase 1/2 trial in patients with relapsed or refractory (AL) amyloidosis.
About Zentalis Pharmaceuticals
Zentalis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers. The Company is developing a broad pipeline of potentially best-in-class oncology candidates, all internally discovered, which include ZN-c3, a Wee1 inhibitor for advanced solid tumors, ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-d5, a BCL-2 inhibitor for hematologic malignancies and related disorders, ZN-e4, an EGFR inhibitor for non-small cell lung carcinoma (NSCLC) and a heterobifunctional degrader of BCL-xL for solid and hematological malignancies. The Company has licensed ZN-c3, ZN-c5 and ZN-d5 to its joint venture, Zentera Therapeutics, to develop and commercialize these candidates in China. Zentalis has operations in both New York and San Diego.
For more information, please visit www.zentalis.com. Follow Zentalis on Twitter at @ZentalisP and on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the development, potential, safety, efficacy, and regulatory and clinical progress of our product candidates, including without limitation ZN-d5, in the Unites States and globally. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to the important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
Investor Contact:
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FAQ
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