Notable Labs Showcases PPMP-Driven Phase 2 Volasertib Trial for R/R AML at AACR 2024

Notable Labs, a company at the forefront of precision oncology, is advancing its Predictive Precision Medicine Platform (PPMP) to predict which patients are likely to respond to the drug volasertib. The company recently unveiled its Phase 2 trial design at the AACR 2024 conference, which combines volasertib with decitabine for patients with relapsed or refractory acute myeloid leukemia (AML). The PPMP is a companion diagnostic tool that aims to enhance patient selection and improve clinical outcomes.

The trial's design is based on a proof-of-concept study involving 41 primary AML samples. Notable Labs is optimistic that its PPMP can effectively identify patients who will respond to treatment, leading to a robust Phase 2 study. The company also plans to implement a dosing optimization strategy to increase patient responses and improve tolerability.

The method involves using ex vivo flow cytometry to evaluate volasertib's impact on AML samples. The results show a strong correlation between volasertib-resistant fractions and the areas under the dose-response curves, which could be used to stratify patients into responders and non-responders. This could predict that approximately 32-33% of de novo patients and 25% of R/R AML patients would respond to volasertib.

Notable Labs is committed to developing predictive precision medicines, using its PPMP to identify responsive patients before treatment. The goal is to increase response rates and overall patient outcomes, accelerating the clinical development of volasertib for this patient population. The company has obtained exclusive worldwide development and commercialization rights for volasertib, except for certain rare pediatric cancers.

Volasertib, a PLK-1 inhibitor, has shown activity in AML and other tumor types, addressing significant unmet medical needs. Notable Labs aims to be a leader in predictive precision medicine, revolutionizing patient treatment by continually advancing and expanding the PPMP across various diseases and medical outcomes.

The company's strategy is to deliver a product's medical impact and commercial value faster than traditional drug development, with a higher likelihood of success. By transforming the standards of care, Notable Labs seeks to have a positive impact on patients and the healthcare community. The full poster detailing the study will be available on the company's website following the AACR event.

Notable Labs is a clinical-stage platform therapeutics company based in Foster City, California, focused on developing predictive precision medicines for cancer patients. The company's PPMP is designed to predict a patient's response to specific therapies, potentially accelerating clinical development. Notable Labs is dedicated to advancing the field of predictive precision medicine and improving patient outcomes.