Prelude Announces Multiple Clinical and Preclinical Poster Presentations at AACR-NCI-EORTC International Conference
“This additional data from our solid tumor trial investigating our potent and selective CDK9 inhibitor, PRT2527, continues to support a best-in-class safety and target engagement profile for the molecule. A second Phase 1 clinical trial in patients with hematological cancers is also underway, with initial data expected in 1H 2024,” stated
Clinical Poster Presentations:
- The overall safety profile observed in this study supports further development of PRT2527 in combination with other targeted therapies in hematological malignancies.
- Initial clinical data from first three dose escalation cohorts (20, 40 and 80 mg QD) were reported.
- Treatment with PRT3645 was associated with a substantial decrease in pRb and Ki67 expression, indicating a high level of target engagement at the doses evaluated.
- PRT3645 exhibited tolerable dose escalation in the initial three dose cohorts of patients with no significant gastrointestinal, hematologic or neurological events reported to date, leveraging its enhanced selectivity profile.
Preclinical Poster Presentations:
“In addition to the preclinical efficacy we have seen with our potent and selective SMARCA2 degrader, PRT3789, as monotherapy, we see added potential in combination with immunotherapies as well as with chemotherapy and targeted therapies, such as KRAS inhibitors. The sensitive and quantitative assays we have developed to measure SMARCA2 degradation in preclinical models will also enable us to assess target engagement in the clinic. We look forward to the translation of these preclinical results in clinical readouts planned for 2024,” said
- PRT3789 is a potent and highly selective SMARCA2 protein degrader that specifically targets SMARCA4-deficient cancer cells.
- In preclinical models, PRT3789 inhibits the growth of SMARCA4-deficient NSCLC tumors as monotherapy and is synergistic in combination with other SOC therapies including chemotherapeutic agents, KRAS G12C inhibitors and anti-PD1 mAb.
- Sensitive and quantitative assays to determine SMARCA2 and SMARCA4 protein levels and changes in SMARCA2-dependent gene expression were developed and will be used to assess selectivity and target engagement following treatment with PRT3789 in the ongoing Phase 1 clinical study.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated discovery, preclinical and clinical development activities for Prelude’s product candidates and the potential benefits of Prelude’s product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although Prelude believes that the expectations reflected in such forward-looking statements are reasonable, Prelude cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Prelude's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Prelude's ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, clinical trial sites and our ability to enroll eligible patients, supply chain and manufacturing facilities, Prelude’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, Prelude's ability to fund development activities and achieve development goals, Prelude's ability to protect intellectual property, and other risks and uncertainties described under the heading "Risk Factors" in documents Prelude files from time to time with the
Vice President, Investor Relations
Source: Prelude Therapeutics, Inc.