WILMINGTON, Del. - Prelude Therapeutics Incorporated (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced interim clinical data from its Phase 1 trial of PRT3789, a novel therapy for patients with SMARCA4-mutated cancers. The findings were presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain.
The early-stage study focused on PRT3789's safety and efficacy in treating non-small cell lung cancer (NSCLC) and esophageal cancer. As of August 5, 2024, the trial had enrolled 65 patients, of whom 46 were efficacy evaluable. Investigators reported that PRT3789 was well-tolerated across eight dosing cohorts, with no dose-limiting toxicities or serious adverse events linked to the study drug. Adverse events were generally mild to moderate, including nausea, decreased appetite, and fatigue.
Of the 26 NSCLC or esophageal cancer patients evaluable for efficacy, seven experienced tumor shrinkage, with three confirmed partial responses. Additionally, one patient has been on treatment for over a year, indicating prolonged stable disease. No tumor shrinkage was observed in patients with other tumor types.
"PRT3789's emerging safety profile and early clinical activity are promising," said Jane Huang, M.D., President and Chief Medical Officer of Prelude. "These data represent initial proof of concept that selective SMARCA2 degradation can yield antitumor activity in certain SMARCA4 mutated cancers."
The company is currently conducting dose escalation in the 9th cohort and plans to identify a biologically active dose for PRT3789 as monotherapy by year-end. The ongoing study also includes backfill cohorts enriched for NSCLC and esophageal cancer patients with Class 1 mutations, as well as a docetaxel combination study.
Prelude aims to establish the safety and tolerability profile of PRT3789, evaluate its activity, pharmacokinetics, and pharmacodynamics, and determine a dose for advancement into registrational clinical trials. The company expects to conclude monotherapy dose escalation in 2024.
The interim Phase 1 data for PRT3789 will also be presented at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics on October 24, 2024.
This article is based on a press release statement.
In other recent news, Prelude Therapeutics has reported favorable safety and clinical activity of its novel cancer drug, PRT3789, in a Phase 1 trial. The drug is being tested on patients with advanced solid tumors carrying a SMARCA4 mutation. In collaboration with pharmaceutical giant Merck, Prelude has also initiated a Phase 2 clinical trial, combining PRT3789 with Merck's anti-PD-1 therapy, KEYTRUDA. These developments come as Prelude ended the first quarter of 2024 with approximately $201.9 million in cash and equivalents, despite reporting no revenues. On the analyst front, Barclays (LON:BARC) downgraded Prelude's stock from Equalweight to Underweight, while H.C. Wainwright maintained a Neutral stance on the company's stock. Notably, Prelude is advancing two key programs, SMARCA2 and CDK9, through clinical trials, with the SMARCA2 degrader, PRT3789, expected to select its phase 2 dose by mid-2024. These are some of the recent developments from Prelude Therapeutics.
InvestingPro Insights
Prelude Therapeutics Incorporated (NASDAQ:PRLD) has been navigating a dynamic market environment, as reflected in the company's latest metrics and analyst insights. According to InvestingPro data, PRLD holds a market capitalization of approximately $277.32 million, indicating the scale at which the company is operating within the clinical-stage precision oncology space. Moreover, the company's Price to Book ratio as of the last twelve months leading up to Q2 2024 stands at 1.48, suggesting how the market values the company in relation to its book value.
While the company is making strides in its clinical trials, it's important to note that analysts have revised their earnings downwards for the upcoming period. This revision could be an indicator of challenges ahead or adjustments in market expectations. Additionally, Prelude's stock price has demonstrated considerable volatility, a factor that investors should consider when assessing the risk profile of their investment.
InvestingPro Tips highlight that Prelude Therapeutics has more cash than debt on its balance sheet, which is a positive sign of financial stability. However, the company is also quickly burning through cash, a point of concern that could impact its ability to sustain long-term research and development activities without seeking additional funding.
For investors looking for a comprehensive analysis of Prelude Therapeutics' financial health and future prospects, InvestingPro offers a range of additional tips. In total, there are 12 InvestingPro Tips available, which can provide deeper insights into the company's performance and potential investment opportunities.
Overall, the InvestingPro data and tips offer valuable context to Prelude's current standing and future outlook, as the company continues to progress through its clinical trials and works towards bringing innovative cancer therapies to market.
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