WILMINGTON, DE — Prelude Therapeutics Incorporated (Nasdaq: PRLD) has unveiled encouraging results from its ongoing Phase 1 trial of PRT3789, a groundbreaking SMARCA2 degrader, at the 36th Annual EORTC-NCI-AACR Symposium in Barcelona, Spain. This announcement marks a significant milestone in the company’s quest to develop targeted cancer therapies.
As of the trial’s recent cutoff date, data from 65 enrolled patients have been analyzed, revealing that PRT3789 is generally well-tolerated through eight dosage levels. The dose-escalation study focuses on patients with advanced cancers carrying SMARCA4 mutations, a group with limited treatment options. Jane Huang, M.D., President and Chief Medical Officer of Prelude, remarked, “We, along with our study investigators, are encouraged by the promising activity shown to date by PRT3789 in this novel first-in-class mechanism for patients who have limited treatment options.”
The trial’s interim results show that PRT3789 demonstrated potential efficacy in heavily pre-treated patients, particularly those with NSCLC or esophageal cancer displaying Class 1 mutations. Partial responses were confirmed in several patients, with higher doses correlating to more profound and sustained SMARCA2 degradation. The safety profile of PRT3789 remains favorable, with most adverse events being mild to moderate, and no dose-limiting toxicities recorded.
Pharmacokinetic analysis revealed a consistent increase in exposure with higher doses, maintaining effective SMARCA2 plasma concentrations at the highest doses tested. Pharmacodynamic assessments further confirmed significant SMARCA2 degradation within peripheral blood mononuclear cells.
Additionally, Prelude presented data on the potential of PRT3789 when combined with standard chemotherapy agents. The combination has demonstrated enhanced anti-tumor activity, offering a new avenue for treatment strategies in SMARCA4-mutant cancers.
In a related presentation, Prelude introduced PRP0004, a potent SMARCA2/4 dual degrader, as a payload for antibody-drug conjugates. Peggy Scherle, Ph.D., Chief Scientific Officer of Prelude, noted, “Preclinical data presented today with our novel approach to develop degrader antibody conjugates by using potent dual degraders of SMARCA2 and 4 as payloads offers first proof-of-concept of effectively and safely targeting an important mechanism to treat cancers beyond those with SMARCA4 mutations.”
Looking ahead, the company plans to conclude the monotherapy dose escalation and identify a biologically active dose for future trials by the end of 2024. Prelude’s strategic focus remains on refining its approach to target high-need patient groups, underpinning its commitment to delivering innovative cancer therapies.
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