WILMINGTON, DE, USA I September 30, 2020 I 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.
SOURCE: Prelude Therapeutics
Post Views: 93
WILMINGTON, DE, USA I September 30, 2020 I 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.
SOURCE: Prelude Therapeutics
Post Views: 93
