PRT7732 / Prelude Therap - LARVOL DELTA

A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation (clinicaltrials.gov) - P1 | N=42 | Active, not recruiting | Sponsor: Prelude Therapeutics | Recruiting ➔ Active, not recruiting | N=104 ➔ 42

Enrollment change • Enrollment closed • Esophageal Adenocarcinoma • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Esophagogastric Junction Squamous Cell Carcinoma • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

Prelude Therapeutics Announces Strategic Business Update (Prelude Therapeutics) - "Prelude...announced it has decided to pause the clinical development of its SMARCA2 degrader program. The decision to pause was based on a comprehensive review of clinical data generated to date and the Company’s assessment of the capital and resource allocation required to advance the SMARCA2 program, versus the JAK2 and KAT6A programs, to key points of value inflection."

Discontinued • Oncology

A phase 1 study of PRT7732, an oral degrader of SMARCA2 in patients with advanced or metastatic SMARCA4-mutated solid tumors [WITHDRAWN] (ESMO 2025) - No abstract available

Clinical • Metastases • P1 data • Oncology • Solid Tumor • SMARCA2 • SMARCA4

Prelude Therapeutics...Provides Corporate Update (GlobeNewswire) - "'We’ve decided to pause further development of PRT3789, and focus solely on PRT7732 as our go-forward strategy for our SMARCA2 Program.'....PRT3789 has completed Phase 1 clinical development in patients with biomarker selected SMARCA4-mutated cancers. The Company anticipates providing updated data from the Phase 1 study by year-end 2025."

Discontinued • P1 data • Trial completion • Solid Tumor

PRT7732 – A potent, highly selective and orally bioavailable SMARCA2 degrader (GlobeNewswire) - "Enrollment continues to advance rapidly, and the Company is currently enrolling patients in the seventh dose escalation cohort (125 mg once daily). The Company expects to provide an initial first-in-human data update including PK/PD, safety and an initial look at clinical activity at biologically relevant doses by year end 2025."

Enrollment status • P1 data • Solid Tumor

Prelude Therapeutics Reports Full Year 2024 Financial Results and Provides Program Outlook for 2025 (GlobeNewswire) - "The Company initiated and enrolled our first patients in a phase 1 multi-dose escalation trial of PRT7732 (NCT06560645) in biomarker selected SMARCA4 mutated cancers. The Company expects to provide an interim data update in the second half of 2025."

P1 data • Non Small Cell Lung Cancer

Prelude Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Clinical Program Updates and Upcoming Milestones:...(i) PRT7732 – A potent, highly selective and orally bioavailable SMARCA2 Degrader:...The Company initiated and enrolled our first patients in a phase 1 multi-dose escalation trial of PRT7732 (NCT06560645) in biomarker selected SMARCA4 mutated cancers....(ii) PRT2527 – A potent and highly selective CDK9 Inhibitor:...PRT2527 is expected to complete monotherapy dose escalation in B-cell malignancies this year. Initiation of dose escalation in myeloid malignancies occurred in the first half of 2024. Interim phase 1 clinical data with potentially best-in-class CDK9 inhibitor, PRT2527 in hematological malignancies will be presented at the American Society of Hematology Annual Meeting in December 2024."

P1 data • Trial status • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Non-Hodgkin’s Lymphoma • Solid Tumor

A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: Prelude Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation (clinicaltrials.gov) - P1 | N=104 | Not yet recruiting | Sponsor: Prelude Therapeutics

Metastases • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Prelude Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Interim Phase 1 data for its first-in-class, highly selective IV SMARCA2 degrader, PRT3789, selected for an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2024 in September....The lead oral candidate, PRT7732, recently was granted IND authorization from the FDA and is expected to enter Phase 1 clinical development in the second half of 2024....PRT2527 is expected to complete monotherapy dose escalation in B-cell malignancies this year. Initiation of dose escalation in myeloid malignancies occurred in the first half of 2024. Interim Phase 1 data is on track for presentation in the fourth quarter of 2024."

IND • New P1 trial • P1 data • Trial status • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lung Cancer • Lymphoma • Mantle Cell Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Solid Tumor

Prelude Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update - "SMARCA2 degrader PRT3789 on track to complete monotherapy dose escalation mid- year and combination with docetaxel has been initiated; initial proof-of concept data expected in second half of 2024....PRT3789 is in Phase 1 clinical development in biomarker selected SMARCA4 mutant patients. Enrollment remains on track, and the Company expects to conclude monotherapy dose escalation mid-2024 and identify recommended Phase 2 dose....The lead oral molecule, PRT7732, is currently in investigational new drug (IND) enabling preclinical studies and on track to enter Phase 1 clinical development in the second half of 2024."

New P1 trial • P1 data • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Preclinical characterization of PRT7732: A highly potent, selective, and orally bioavailable targeted protein degrader of SMARCA2 (AACR 2024) - "In summary, our orally bioavailable SMARCA2 degraders induce synthetic lethality in SMARCA4-deficient cancers in vitro and in vivo. Efforts to further evaluate these compounds in additional models and in combination with other agents are ongoing."

Preclinical • Lung Cancer • Oncology • Solid Tumor • CRBN • GSPT1 • IKZF2 • SALL4 • SMARCA2 • SMARCA4

Prelude Highlights Continued Strength of Discovery Engine at 2024 AACR Annual Meeting (GlobeNewswire) - "Identified potent, selective, well-tolerated and orally bioavailable SMARCA2 degrader, PRT7732. PRT7732 exhibits >3000-fold selectivity for SMARCA2 over SMARCA4, with low nanomolar potency in cell based assays. Prelude completed IND-enabling studies for PRT7732 and is on track to enter Phase 1 clinical trials in the second half of 2024."

New P1 trial • Preclinical • Oncology

Prelude Announces Acceptance of Multiple Preclinical Abstracts at the 2024 AACR Annual Meeting (GlobeNewswire) - '"We look forward to sharing data on the preclinical characterization of our lead oral SMARCA2 degrader, PRT7732, which is on track to advance into Phase 1 clinical development in the second half of this year, and to presenting additional preclinical data for our highly selective and potent CDK9 inhibitor, PRT2527, that supports its potential therapeutic value in combination with BTK and BCL2 inhibitors in lymphoid malignancies. For our next generation CDK4/6 inhibitor, PRT3645, we will present preclinical data supporting its potential therapeutic value in combination with other targeted therapies for a range of tumor types in addition to breast cancer.'"

New P1 trial • Preclinical • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Prelude Therapeutics Reports Full Year 2023 Financial Results and Outlines Key Objectives for 2024 (GlobeNewswire) - "SMARCA2 degrader PRT3789 on track to complete monotherapy dose escalation mid-year and initiate combination with docetaxel in first half of 2024; initial proof-of concept data expected in second half of 2024....CDK9 inhibitor PRT2527 on track to complete monotherapy dose escalation mid-2024; initiate dosing in combination with zanubrutinib in first quarter of 2024; initial hematological proof-of-concept data expected in second half of 2024....The lead oral molecule, PRT7732, is currently in investigational new drug (IND) enabling studies and on track to enter Phase 1 clinical development in the second half of 2024."

New P1 trial • P1 data • Trial status • Chronic Lymphocytic Leukemia • Mantle Cell Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Richter's Syndrome • Small Lymphocytic Lymphoma

Prelude Announces Strategic Pipeline Progress and Updates, including its Partnership with AbCellera, and Reports Third Quarter Financial Results (GlobeNewswire) - "A Phase 1 multi-dose escalation clinical trial of PRT3789 is ongoing (NCT05639751) in biomarker-selected SMARCA4 mutated cancers. Prelude intends to evaluate PRT3789 as monotherapy as well as in combination and plans to share initial Phase 1 data in mid-2024....Prelude recently nominated a potent, orally bioavailable and highly selective SMARCA2 degrader candidate. This compound is >1000x selective for SMARCA2 over SMARCA4 and is currently in IND-enabling studies. Prelude expects to file an IND in the first half of 2024."

IND • New P1 trial • Trial status • Solid Tumor

Prelude Therapeutics Announces Launch of Proposed Public Offering (GlobeNewswire) - "Prelude Therapeutics Incorporated...today announced that it has commenced an underwritten public offering of $100.0 million of shares of common stock and, in lieu of common stock to investors that so choose, pre-funded warrants to purchase shares of common stock. All of the shares of common stock and pre-funded warrants are being offered by Prelude. In addition, Prelude has granted the underwriter a 30-day option to purchase additional shares of its common stock in an amount equal to 15% of the securities offered in the public offering....Prelude intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to advance its current clinical pipeline, including PRT2527, PRT1419, PRT3645 and PRT3789; advance its research and discovery efforts including its efforts for a new SMARCA2 oral molecule; and support organizational growth and for working capital and other general corporate purposes."

Financing • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Brain Cancer • Breast Cancer • Chronic Lymphocytic Leukemia • CNS Tumor • Ewing Sarcoma • Genito-urinary Cancer • Glioblastoma • Glioma • Head and Neck Cancer • Hematological Malignancies • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Leukemia • Liposarcoma • Lung Cancer • Lymphoma • Malignant Pleural Mesothelioma • Mantle Cell Lymphoma • Mesothelioma • Multiple Myeloma • Myelodysplastic Syndrome • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Prostate Cancer • Sarcoma • Small Lymphocytic Lymphoma • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Synovial Sarcoma • T Acute Lymphoblastic Leukemia • Thoracic Cancer • Triple Negative Breast Cancer

Prelude Therapeutics Reports Full Year 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "SMARCA2 Targeted Protein Degrader Program:...Key objectives include: (i) Provide Clinical update on PRT3789 2H 2023; (ii) Advance an oral SMARCA2 degrader for investigational new drug (IND) submission in 1H 2024."

IND • P1 data • Oncology • Solid Tumor