PRT1419 IV / Prelude Therap - LARVOL DELTA

PRT1419 as Monotherapy or in Combination With Azacitidine or Venetoclax in R/R Myeloid or B-cell Malignancies (clinicaltrials.gov) - P1 | N=21 | Terminated | Sponsor: Prelude Therapeutics | N=132 ➔ 21 | Trial completion date: Nov 2025 ➔ Jan 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: May 2025 ➔ Jan 2024; Company Decision

Combination therapy • Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Chronic Myelomonocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

PRT1419 as Monotherapy or in Combination With Azacitidine or Venetoclax in R/R Myeloid or B-cell Malignancies (clinicaltrials.gov) - P1 | N=132 | Active, not recruiting | Sponsor: Prelude Therapeutics

Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Chronic Myelomonocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

PRT1419 as Monotherapy or in Combination With Azacitidine or Venetoclax in R/R Myeloid or B-cell Malignancies (clinicaltrials.gov) - P1 | N=132 | Active, not recruiting | Sponsor: Prelude Therapeutics | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Monotherapy • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Chronic Myelomonocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Prelude Announces Strategic Pipeline Progress and Updates, including its Partnership with AbCellera, and Reports Third Quarter Financial Results (GlobeNewswire) - "(i) MCL-1 inhibitor (PRT1419):...Given the overlap with the CDK9 program, Prelude does not plan to advance PRT1419 further at this time; (ii) CDK4/6 inhibitor (PRT3645):...Given the focus of the Company on SMARCA2 and CDK9, Prelude will not advance the program further and is actively pursuing further clinical development with external partners."

Pipeline update • Hematological Malignancies • Solid Tumor

PHASE 1 STUDY OF PRT1419 (MCL1 INHIBITOR) AS MONOTHERAPY OR IN COMBINATION WITH AZACITIDINE OR VENETOCLAX IN PATIENTS WITH RELAPSED/REFRACTORY MYELOID OR B-CELL MALIGNANCIES (ICML 2023) - "As monotherapy, pts will receive escalating doses of intravenous PRT1419 once weekly in a 28-day cycle using a 3 + 3 dose escalation design until a maximum tolerated dose (MTD) or RP2D dose has been reached. The primary endpoints include safety, tolerability, dose-limiting toxicities (DLTs), and RP2D of PRT1419 as monotherapy. Secondary endpoints include safety, tolerability, DLTs, RP2D for PRT1419 in combination"

Clinical • Combination therapy • IO biomarker • Monotherapy • P1 data • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Oncology • BCL2 • MCL1

Prelude Therapeutics Announces First Quarter 2023 Financial Results and Operations Update (GlobeNewswire) - P1 | N=26 | NCT04837677 | Sponsor: Prelude Therapeutics | "PRT1419- MCL1 Inhibitor Program: PRT1419 demonstrated an acceptable safety and tolerability profile in patients with advanced and metastatic solid tumors, with the most common TRAEs of nausea, vomiting, and diarrhea. Neutropenia was deemed to be dose related. No cardiac toxicity was observed. Pharmacokinetics/pharmacodynamics and safety data in the 80 mg/m2 QW PRT1419 dose cohort support further evaluation of this dose in future studies.... Further investigation of PRT1419 in patients with hematologic malignancy is ongoing. The Company is on track to determine the RP2D in hematological RP2D and will provide a clinical update at year end."

P1 data • Hematological Malignancies • Oncology • Solid Tumor

Prelude Therapeutics Reports Full Year 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "PRT1419- MCL1 Inhibitor Program:...Key 2023 objectives for this program include: (i) Solid tumor safety data to be presented at AACR 2023; (ii) RP2D expected in hematological malignancies in 2H 2023; (iii) Hematological malignancy data expected to be presented in 2H 2023."

P1 data • Hematological Malignancies • Oncology • Solid Tumor

A Study of PRT1419 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=26 | Completed | Sponsor: Prelude Therapeutics | Active, not recruiting ➔ Completed | Trial completion date: Aug 2023 ➔ Feb 2023 | Trial primary completion date: Aug 2023 ➔ Feb 2023

Metastases • Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • Cervical Cancer • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

PRT1419 as Monotherapy or in Combination With Azacitidine or Venetoclax in R/R Myeloid or B-cell Malignancies (clinicaltrials.gov) - P1 | N=132 | Recruiting | Sponsor: Prelude Therapeutics | N=30 ➔ 132 | Trial completion date: Mar 2024 ➔ Nov 2025 | Trial primary completion date: Sep 2023 ➔ May 2025

Combination therapy • Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Chronic Myelomonocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

A Study of PRT1419 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Prelude Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Breast Cancer • Cervical Cancer • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

A Study of PRT1419 Injection in Patients With Relapsed/Refractory Hematologic Malignancies (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Prelude Therapeutics | Trial completion date: Nov 2023 ➔ Mar 2024

Trial completion date • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology

A Study of PRT1419 Injection in Patients With Relapsed/Refractory Hematologic Malignancies (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Prelude Therapeutics; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology

Prelude Therapeutics Announces Third Quarter 2021 Financial Results and Operations Update (GlobeNewswire) - “PRT811: Phase 1 Dose Escalation Study Data Presented at the AACR-NCI-EORTC Annual Meeting; Dose Expansion Portion of Phase 1 Trial to Commence 4Q21...Prelude will shortly commence the dose expansion portion of the Phase 1 trial in selected patients with central nervous system cancers (CNS) and non-CNS cancers. The Company expects to present data from the expansion cohorts in 2022....Phase 1 Dose Escalation Portion of Oral and Intravenous (IV) PRT1419 Trial Ongoing...The Company expects to add dose expansion and combination cohorts to the Phase 1 clinical trial in the first half of 2022.”

P1 data • Trial status • Acute Myelogenous Leukemia • Brain Cancer • CNS Tumor • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • Solid Tumor

A Study of PRT1419 Injection in Patients With Relapsed/Refractory Hematologic Malignancies (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: Prelude Therapeutics

Clinical • New P1 trial • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology

A Study of PRT1419 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Prelude Therapeutics; Not yet recruiting ➔ Recruiting; Trial completion date: Apr 2023 ➔ Aug 2023; Initiation date: Apr 2021 ➔ Aug 2021; Trial primary completion date: Apr 2023 ➔ Aug 2023

Clinical • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Breast Cancer • Cervical Cancer • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

Prelude Therapeutics Announces Second Quarter 2021 Financial Results and Operations Update (GlobeNewswire) - "Research and Development (R&D) Expenses: For the second quarter of 2021, R&D expense increased by $12.6 million to $22.4 million for the three months ended June 30, 2021 from $9.8 million for the three months ended June 30, 2020. The increase was mainly due to increased clinical research costs for the PRT543, PRT811 and PRT1419 (Oral and IV) programs, and increased chemistry, manufacturing and other costs for those trials."

Commercial • Oncology

Prelude Therapeutics Announces First Quarter 2021 Financial Results and Operations Update (GlobeNewswire) - "For the first quarter of 2021, R&D expense increased by $7.9 million to $16.5 million. The increase was mainly due to increased clinical research costs for the PRT543 and PRT811 clinical trials and increased costs associated with the initiation of the clinical trial for oral PRT1419, as well as preparation for the anticipated initiation of the Phase 1 trial for IV PRT1419 in the first half of 2021. We also incurred an increase in chemistry, manufacturing, and other costs for those trials."

Commercial • New P1 trial • Hematological Malignancies • Oncology