Wilmington, DE (Press Release) – 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.

About 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.

Source: Prelude Thera­peutics.