WILMINGTON, DE — Prelude Therapeutics Incorporated (Nasdaq: PRLD) has reported its fiscal results for the year end of December 31, 2023. It also set forth its objectives for the coming year, underscoring a focused and determined approach to developing potentially safer and more effective treatments for patients with unmet needs.
A key focus of 2023 was strengthening its pipeline, and the results speak for themselves. Both its first-in-class IV SMARCA2 degrader compound, PRT3789, and potentially best-in-class CDK9 inhibitor, PRT2527, have shown significant progress and are poised to deliver promising initial proof-of-concept data in 2024.
Dr. Kris Vaddi, CEO of Prelude, expressed confidence in the potential therapeutic value of SMARCA2 to target a wide range of cancers with SMARCA4 mutations. A notable step forward is the expected advancement of their lead oral SMARCA2 degrader into Phase 1 clinical development later this year.
Strategic partnerships remain a critical part of Prelude’s growth strategy, as seen in their collaboration with AbCellera. The aim is to co-create a portfolio of first-in-class precision Antibody-drug Conjugates (ADCs) with Prelude’s selective and potent molecules and degrader payloads, paired with AbCellera’s unique antibodies. A standout in the portfolio is a potent SMARCA degrader, promising to enhance the reach of SMARCA programs.
2024 heralds significant milestones for Prelude’s clinical programs. For instance, PRT3789, a potent and highly selective SMARCA2 degrader designed for SMARCA4 mutation patients, is on track to complete monotherapy dose escalation by mid-year and schedules a combination with docetaxel in the first half of 2024. Evidence so far paints an encouraging picture of PRT3789, an acceptable safety profile, selective and potent degradation of SMARCA2, and the potential to address a high unmet medical need.
PRT2527, a potent CDK9 inhibitor, follows a similar path of promise with impressive results in hematological indications such as B-cell malignancies and acute myeloid leukemia (AML). Prelude plans to initiate combination dosing with zanubrutinib in 2024 and complete monotherapy dose escalation by mid-year.
The company also intends to venture into Phase 1 clinical trial with an orally bioavailable SMARCA2 degrader, PRT7732, in the latter part of 2024. Currently, in investigational new drug (IND) enabling studies, PRT7732 promises patient-friendly dosing and potential use in earlier therapy lines.
Financially, Prelude ended 2023 in a strong position. Its cash and cash equivalents totaled $232.9 million, providing a secure financial runway into 2026. It reported a rise in R&D expenses, owing to the timing of clinical development programs and an increase in non-cash stock-based compensation expense. G&A expenses saw a slight decrease, revealing proficient management of general and administrative expenses. The year ended with a net loss of $121.8 million or $2.02 per share.
As Prelude gears up to embrace 2024, it plans to initiate Phase 2 clinical trials for PRT7732 in combination with existing standard of care therapies for multiple types of cancer. The company also aims to expand its pipeline by advancing other promising drug candidates through preclinical studies and potentially into clinical development.
In addition to its focus on developing innovative cancer treatments, Prelude is committed to creating sustainable value for patients, employees, and shareholders. This commitment is reflected in its corporate responsibility initiatives, which include reducing its carbon footprint and promoting diversity and inclusion within the company.
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