WILMINGTON, DE — Prelude Therapeutics Incorporated (Nasdaq: PRLD) has revealed groundbreaking clinical data on its novel therapeutic agent, PRT3789, at the European Society of Medical Oncology (ESMO) Congress 2024 in Barcelona. This innovative treatment targets SMARCA2 degradation, offering new hope for patients with SMARCA4 mutant cancers, which are characterized by limited treatment options and aggressive disease progression.
PRT3789, currently in Phase 1 clinical trials, has been designed as a first-in-class, highly selective SMARCA2 degrader. This mechanism of action is critical as it aims to degrade SMARCA2 proteins, potentially inhibiting tumor growth in patients with SMARCA4 mutations. “We are excited for the opportunity to share the first ever clinical data of a novel, highly-selective SMARCA2 degrader,” stated Jane Huang, M.D., President and Chief Medical Officer of Prelude. The ongoing trial seeks to determine the safety, tolerability, and preliminary efficacy of PRT3789 both as a standalone treatment and in combination with docetaxel.
As of the March 7, 2024 data cutoff, 40 patients have participated, including those with non-small cell lung cancer (NSCLC), pancreatic, breast, and esophageal cancers. With dose escalation proceeding through six levels, from 24-212 mg, notable findings include no dose-limiting toxicities or serious adverse events related to the study drug. Common adverse effects have been manageable, with nausea, constipation, and dyspnea being among the most reported.
Importantly, dose-related pharmacokinetic and pharmacodynamic responses have been observed, including increased drug exposure (AUC) and reductions in SMARCA2 levels. Clinical benefits have been noted, with partial responses and tumor shrinkage in patients with heavily pretreated esophageal cancer and NSCLC, signaling PRT3789’s potential efficacy.
Prelude plans to conclude dose escalation by the end of 2024 and determine an optimal dose for subsequent Phase 2 trials. The company will host a conference call and webcast on September 13 to discuss these promising findings and its ongoing strategic plans.
This announcement marks a pivotal moment in the pursuit of targeted cancer therapies, offering a potential new avenue for treating SMARCA4 mutant cancers. Further updates will be shared at ESMO, providing oncologists with insight into the future of this innovative treatment.
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