Prelude Therapeutics Announces Dosing of First Patient in Phase 1 Trial of MCL1 Inhibitor PRT1419 for the Treatment of Relapsed/Refractory Hematologic Malignancies
WILMINGTON, Del., Sept. 30, 2020 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced that the first patient has been dosed in its first-in-human Phase 1 open-label, multicenter, dose-escalation study of PRT1419 in patients with relapsed/refractory hematologic malignancies. PRT1419, the Company’s third clinical candidate, is designed to be an orally available, potent and selective MCL1 inhibitor.
The dose escalation portion of the study will be conducted across two groups, including in patients with relapsed/refractory high-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) (Group A), as well as patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (Group B). The dose expansion portion of the trial will evaluate either monotherapy PRT1419 or, for a cohort of patients with AML or MDS, in combination with existing standards of care. The primary objectives of the study will seek to identify dose-limiting toxicities, a maximum tolerated dose, and a recommended Phase 2 dose. Secondary objectives will assess the safety and tolerability, pharmacokinetic profile, and anti-tumor activity of PRT1419.
PRT1419 is designed to be a potent and selective inhibitor of the anti-apoptotic protein, MCL1. MCL1 has been shown to have a critical role in promoting cancer cell survival and is frequently found to be amplified or overexpressed in both solid tumors and hematologic cancers. Inhibition of MCL1 expression and/or function is therefore of considerable therapeutic interest in cancer. Small molecule MCL1 inhibitors have been shown to be efficacious as monotherapy in preclinical models of multiple myeloma, acute myeloid leukemia, and lymphoma. PRT1419 demonstrated potent and selective inhibition of MCL1 in vitro and in vivo that resulted in tumor regressions in preclinical models of hematologic malignancies following once weekly oral dosing.
About Prelude Therapeutics
Prelude Therapeutics is a clinical-stage precision oncology company focused on discovering and developing small molecule therapies optimized to target the key driver mechanisms in cancers with high unmet need.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Prelude Therapeutics’ plans to develop small-molecule cancer therapies, expectations from current data, the execution of the Phase 1 clinical trial for PRT1419 as designed, any expectations about safety, efficacy, timing and ability to commence or complete clinical studies and to obtain regulatory approvals for PRT1419 and other candidates in development, and the ability of PRT1419 to treat relapsed/refractory hematologic malignancies or related indications.
Statements including words such as “believe,” “plan,” “continue,” “expect,” “will,” “develop,” “signal,” “potential,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements.
Forward-looking statements are subject to risks and uncertainties that may cause Prelude Therapeutics’ actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including Prelude Therapeutics’ ability to develop, obtain regulatory approval for or commercialize any product candidate, Prelude Therapeutics’ ability to protect intellectual property, the potential impact of the COVID-19 pandemic and the sufficiency of our cash, cash equivalents and investments to fund our operations. These forward-looking statements speak only as of the date hereof and Prelude Therapeutics specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.
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