- Prelude Therapeutics Inc PRLD has announced data from the dose-escalation portions of Phase 1 trials of PRT543 and PRT811.
- The data will be featured at the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics.
- PRT543 demonstrated target engagement and inhibition of PRMT5 functional activity, evidenced by a 69% reduction in serum symmetric dimethylarginine (sDMA) at a dose of 45 mg/5x per week.
- One complete response (CR) was maintained for over 18 months in a patient with HRD+ ovarian cancer.
- Stable disease (SD) persisting for over six months was seen in five patients, including four with adenoid cystic carcinoma (ACC) and one with uveal melanoma.
- The most common grade 3 or higher treatment-related adverse events were thrombocytopenia (27%) and anemia (12%), reversible upon treatment interruption.
- PRT811 demonstrated dose-dependent inhibition of PRMT5 activity, evidenced by an 83% reduction in serum sDMA at 600 mg daily.
- PRT811 demonstrated signs of preliminary clinical activity, including an IDH1 mutated GBM patient who experienced a partial response (PR) that evolved into a durable CR for more than 13 months.
- One patient with splicing-mutant (SF3B1) uveal melanoma demonstrated SD for more than six months with a 25% tumor regression and remains on treatment.
- One additional patient (800 mg twice daily) with SF3B1 uveal melanoma had an unconfirmed PR and 47% decrease in target lesion.
- A patient with triple-negative breast cancer (800 mg QD) demonstrated a 27% decrease in target lesions.
- Related: Why BofA Is Turning Bullish On Prelude Therapeutics.
- Price Action: PRLD stock is down 33.3% at $19.20 during the market session on the last check Thursday.
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