Notable Labs Presents the Design Plan for the PPMP-Enabled Phase 2 Trial with Volasertib for Relapsed/Refractory AML at AACR 2024

• Poster outlines the parameters for developing a flow-cytometry-based PPMP as a companion diagnostic to predict volasertib responders, based on a proof-of-concept study using 41 primary acute myeloid leukemia (AML) samples
• Plans to incorporate a dose optimization prelude to enhance patient response and tolerability also outlined in the poster

FOSTER CITY, Calif., April 09, 2024 (GLOBE NEWSWIRE) -- Notable Labs, Ltd. (Nasdaq: NTBL) (“Notable” or the “Company”), a clinical-stage precision oncology company developing a new class of cancer therapies identified by its Predictive Precision Medicine Platform (PPMP), today presented the design for the PPMP-enabled Phase 2 trial with volasertib, in combination with decitabine, in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) at the American Association for Cancer Research (AACR 2024) being held in San Diego, CA (Poster abstract 5178).

“We are very pleased to share more data regarding our clinical program and proprietary platform with the oncology community at AACR 2024. Presenting a summary of the Phase 2 volasertib study design in AML provides us with an opportunity to highlight the potential for the PPMP to effectively predict responders, and enroll an responder-enriched patient population, in our upcoming clinical program. Our clinical program will incorporate the co-development of a companion diagnostic test,” said Thomas Bock, M.D., Chief Executive Officer of Notable.

Joseph Wagner, Ph.D., Chief Scientific Officer of Notable, commented, “The abstract highlights technical features of volasertib on Notable’s PPMP, including our method to develop a companion diagnostic test and define a cut-off value to predict responders. Based on the robust results of a 41-sample proof-of-concept study summarized in the poster, we are optimistic about the potential for PPMP to improve patient selection and lead to a strong Phase 2 study. In addition, we look forward to implementing a dosing optimization plan, including standardized use of best supportive care and introduction of body surface area-based dosing, to enhance patient responses and tolerability.”

Poster Highlights:

Guided by a predictive ex vivo test: Bringing the PLK1 inhibitor volasertib back into the clinic for venetoclax-HMA relapsed/refractory acute myeloid leukemia patients

Overview: While prior studies of volasertib demonstrated an approximately 30% complete response/complete response with incomplete count recovery (CR/CRi) rate in de novo AML patients in combination with cytarabine, development was halted in part due to toxicity potentially related to the use of a flat dose, rather than patient-specific, body-surface area (BSA) dosing. Notable Labs provided an updated plan for the design of an open label Phase 2 study, including a dose optimization plan aimed at reducing toxicity while maintaining efficacy and an overview of study objectives and endpoints. As part of the study, a companion diagnostic assay to predict responders will be co-developed utilizing the Company’s proprietary flow-cytometry-based PPMP.