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Prelude Therapeutics Incorporated (Nasdaq: PRLD) is a clinical-stage biopharmaceutical company focused on developing innovative small molecule therapies targeting key mechanisms in cancers with high unmet needs. Founded in 2016 and headquartered in Wilmington, Delaware, the company's mission is to deliver precision oncology treatments that can address the critical pathways in cancer cells.
Prelude's robust pipeline includes several promising drug candidates currently in clinical development:
- PRT543: This candidate is in Phase 1 clinical trials targeting select solid tumors and myeloid malignancies in patients who are refractory to or intolerant of established therapies.
- PRT811: Also in Phase 1 trials, PRT811 focuses on solid tumors, including glioblastoma multiforme and primary central nervous system lymphomas.
- PRT1419: A potent and selective inhibitor of the anti-apoptotic protein MCL1, which is undergoing clinical evaluation for its efficacy and safety in cancer treatment.
- PRT2527: This highly selective CDK9 inhibitor demonstrates substantial potential in treating solid and hematological malignancies and aims to minimize off-target toxicities.
- PRT3645: A next-generation CDK4/6 inhibitor that shows promise for better safety, tolerability, and efficacy in various cancers beyond breast cancer.
- PRT3789: A first-in-class SMARCA2 protein degrader targeting cancers with SMARCA4 mutations.
In recent developments, Prelude has extended its cash runway into 2026 following a successful public offering, raising approximately $113 million in gross proceeds. Their strategic collaboration with AbCellera aims to co-develop innovative antibody drug conjugate therapies, combining AbCellera's antibody discovery platform with Prelude's expertise in medicinal chemistry and drug development.
Prelude's financial strength is evident with cash, cash equivalents, and marketable securities totaling $255 million as of June 30, 2023. Their focused approach on advancing their pipeline and making critical strategic decisions is supported by clinical data showing promising efficacy and safety profiles for their drug candidates, such as PRT2527 and PRT1419. The company's commitment to addressing cancers with high unmet needs positions it as a significant player in precision oncology.
For more detailed information and the latest updates on Prelude Therapeutics' research advancements, financial performance, and strategic initiatives, visit their official website and follow them on LinkedIn and Twitter.
Prelude Therapeutics (NASDAQ: PRLD) presented interim clinical data from its Phase 1 dose-escalation trial of PRT2527, a CDK9 inhibitor, both as monotherapy and combined with zanubrutinib in relapsed/refractory lymphoid malignancies. The study included 46 patients across multiple dosing cohorts.
Key findings showed an overall response rate of 17.4% (4 of 23 patients) for monotherapy and 38.5% (5 of 13 patients) for combination therapy. The drug demonstrated an acceptable safety profile, with neutropenia (48%) and nausea (33%) as the most common side effects. The company has selected the 18 mg/m2 dose level for confirmation and plans to seek a partner for future development while focusing resources on their SMARCA degrader programs.
Prelude Therapeutics (Nasdaq: PRLD) has announced its participation in the upcoming Citizens JMP Securities Hematology and Oncology Summit, scheduled for December 2, 2024. The virtual event will feature a fireside chat at 11:30 a.m. ET with CEO Kris Vaddi, Ph.D., and President/CMO Jane Huang, M.D. The session will be available via webcast on the company's website and archived for 90 days.
Prelude Therapeutics specializes in precision oncology, developing innovative medicines for high-unmet cancer patient needs. Their pipeline includes first-in-class SMARCA2 degraders (both IV and oral) and a CDK9 inhibitor. The company is also advancing Precision ADCs through partnerships.
Prelude Therapeutics (PRLD) reported Q3 2024 financial results and clinical updates. Key highlights include interim data from Phase 1 study of PRT3789, showing clinical proof of concept in SMARCA4-mutated cancers. The company initiated Phase 1 trial for PRT7732 and presented preclinical data from its Precision ADC platform. Financial position remains strong with $153.6M cash runway into 2026. Q3 net loss was $32.3M ($0.43/share). R&D expenses increased to $29.5M from $26.3M year-over-year, while G&A expenses rose to $7.9M from $7.1M.
Prelude Therapeutics presented interim data from its ongoing Phase 1 trial of PRT3789, a SMARCA2 degrader for cancer patients with SMARCA4 mutations. Of 65 patients treated, the drug showed promising results with 4 confirmed partial responses among 26 evaluable NSCLC or esophageal patients with Class 1 mutations. Higher doses demonstrated deeper SMARCA2 degradation, with 2 of 9 NSCLC patients showing confirmed responses at doses of 283mg or higher.
The drug was generally well-tolerated, with mostly mild to moderate adverse events. Initial combination study with docetaxel showed an acceptable safety profile. The company also presented first preclinical proof-of-concept data from their novel SMARCA2/4 dual degrader payload program.
Prelude Therapeutics (Nasdaq: PRLD) announced the publication of three abstracts for presentation at the 36th EORTC-NCI-AACR Symposium in Barcelona, Spain from October 23-25, 2024. The abstracts focus on the company's SMARCA Degrader Programs, including:
1. First clinical results from a Phase 1 trial of PRT3789, a first-in-class SMARCA2 degrader, in patients with advanced solid tumors with SMARCA4 mutations.
2. Discovery of first-in-class precision antibody drug conjugates with a potent SMARCA 2/4 dual degrader payload.
3. The selective SMARCA2 degrader, PRT3789, enhancing the efficacy of standard chemotherapy in SMARCA4 mutant NSCLC models.
Prelude expects to conclude monotherapy dose escalation for PRT3789 by year-end 2024 and identify the biologically active dose for future trials. The company is also enrolling patients in back-fill cohorts enriched for NSCLC and SMARCA4 loss-of-function mutations at higher dose levels.
Prelude Therapeutics (NASDAQ: PRLD) announced promising initial clinical data for PRT3789, its first-in-class SMARCA2 degrader, in a Phase 1 trial. The drug showed encouraging anti-tumor activity in patients with SMARCA4-mutated non-small cell lung cancer (NSCLC) and esophageal cancer. Key findings include:
- 3 confirmed partial responses observed
- 7 out of 26 evaluable NSCLC or esophageal patients showed tumor shrinkage
- Generally well-tolerated safety profile with no dose-limiting toxicities
- Dose escalation continuing to 9th cohort (500mg once weekly)
The company plans to confirm the biologically active dose for PRT3789 monotherapy by year-end and advance combination studies with docetaxel. These results represent initial proof of concept for selective SMARCA2 degradation in certain SMARCA4 mutated cancers.
Prelude Therapeutics (Nasdaq: PRLD) has announced the publication of an abstract for their novel SMARCA2 degrader, PRT3789, to be presented at the ESMO Congress 2024. The presentation will showcase the first clinical data for this highly-selective compound in patients with advanced solid tumors harboring SMARCA4 mutations.
Key points from the abstract include:
- 40 patients enrolled across various cancer types
- No dose-limiting toxicities or drug-related serious adverse events reported
- Dose-dependent decreases in SMARCA2 levels observed
- Clinical activity noted, including partial responses and tumor shrinkage
Prelude will host an investor webcast on September 13, 2024, to discuss the updated data presented at ESMO.
Prelude Therapeutics (NASDAQ: PRLD) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:
- Interim Phase 1 data for PRT3789, a first-in-class IV SMARCA2 degrader, selected for oral presentation at ESMO 2024
- Received FDA IND authorization for PRT7732, a first-in-class oral SMARCA2 degrader
- Announced clinical collaboration with Merck to evaluate PRT3789 with KEYTRUDA in SMARCA4-mutated cancers
- CDK9 inhibitor PRT2527 on track to report interim Phase 1 data in Q4 2024
- Cash runway into 2026 with $179.8 million as of June 30, 2024
Q2 2024 financials: R&D expenses increased to $29.5 million, G&A expenses rose to $7.7 million, and net loss was $34.7 million ($0.46 per share).
Prelude Therapeutics has announced a clinical collaboration with Merck to evaluate the combination of Prelude's PRT3789, a selective SMARCA2 degrader, with Merck's anti-PD-1 therapy, KEYTRUDA, in patients with SMARCA4-mutated cancers. The Phase 2 clinical study aims to explore the potential of this combination to enhance anti-tumor activity due to the complementary mechanisms of the two treatments. Prelude will sponsor the trial, while Merck will supply KEYTRUDA. PRT3789 is in Phase 1 development for SMARCA4 mutant patients, with dose escalation expected to conclude mid-2024. Early pre-clinical data indicated promising anti-tumor immunity and tumor regression when combining SMARCA2 degraders with anti-PD-1 therapies. Both companies retain commercial rights to their respective treatments.
Prelude Therapeutics, a clinical-stage precision oncology company, announced its participation in two notable healthcare conferences this June. CEO Kris Vaddi will engage in a fireside chat at the Jefferies Global Healthcare Conference on June 6th at 1:30 p.m. ET. Additionally, Dr. Vaddi will present at the Goldman Sachs 45th Annual Global Healthcare Conference on June 12th at 10:40 a.m. ET. Both events will be webcast live and archived on the company's website for 90 days.
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