eClinical Technology and Industy News

Notable Presents Clinical Validation Data from Two Phase 2 Trials in Adult and Pediatric Acute Myelogenous Leukemia at the 63rd American Society of Hematology (ASH) Annual Meeting

-Studies demonstrate high correlation between predicted response by Notable’s predictive precision medicines platform and actual clinical response, short-term and at one year-

-Interim analyses of studies with MD Anderson Cancer Center and Texas Children’s Hospital investigators corroborate platform prediction data from Standford University collaboration-

Excerpt from the Press Release:

FOSTER CITY, Calif.–(BUSINESS WIRE)–Notable Labs, Inc. (Notable), a clinical-stage platform therapeutics company, announced results from two ongoing Phase 2 clinical trials examining the performance of its high-fidelity predictive precision medicines platform in predicting clinical outcomes in acute myelogenous leukemia (AML) standard-of-care settings. These data were recently presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition.

Data from the first clinical trial were presented in a poster entitled “Ex Vivo Drug Sensitivity Assay Correlates with Clinical Response and Identifies Panobinostat and Bortezomib as a Potential Novel Drug Combination for Pediatric AML”. In a trial conducted at Texas Children’s Hospital, pediatric and young adult de novo AML patients were treated with ADE (Cytarabine, Daunorubicin, Etoposide) alone or in combination with Atovaquone. Peripheral blood or bone marrow samples obtained prior to treatment (n=13) were assessed on Notable’s ex vivo predictive precision medicines platform for responsiveness to ADE. No treatment decisions were made based on these results. Importantly, ex vivo response prediction scores correlated with both minimal residual disease (MRD; r=0.63) and 1-year relapse-free survival (RFS; r=0.59) in this AML population. Moreoever, the Notable predictive score accurately separated responders and non-responders using a MRD threshold of 1%, suggesting that pre-selection of predicted responders using Notable’s platform could potentially identify pediatric AML patients who were likely to respond to standard induction therapy and prevent unnecessary toxicity and delay to more efficacious treatment for treatment non-responsive patients.

Data from the second clinical trial were presented in a poster entitled “Prediction of Clinical Response to Venetoclax Plus Decitabine in AML Using a 7-Day Ex Vivo Assay”. In this ongoing Phase 2 trial, currently being conducted at MD Anderson Cancer Center, unfit de novo or relapsed/refractory AML patients are being treated with venetoclax combined with decitabine. In order to determine the utility of Notable’s precision medicines platform in predicting responding patients in this clinical setting, peripheral blood samples obtained prior to treatment were assessed for ex vivo responsiveness to venetoclax plus decitabine. In the initial group of patients, Notable’s predictive platform correctly identified 5 out of 6 patients demonstrating significant response to this treatment (CR + CRi), suggesting that pre-selection of patients using Notable’s platform could lead to enhanced response rates in adult unfit and relapsed/refractory AML patients eligible for venetoclax plus decitabine.

“These two clinical studies provide further validation of Notable’s predictive precision medicines platform in standard of care settings. These exciting data advance our mission to design and deliver predictive precision medicines by matching treatments with precisely the patients who clinically respond to them,” says Joe Wagner, PhD, Chief Scientific Officer of Notable.

“The ability to accurately predict clinical response is especially meaningful for pediatric patients with life-threatening conditions, and progress on this front is important for our patients,” says Alexandra Stevens, Assistant Professor, Section of Hematology-Oncology at Texas Children’s Hospital. “Accurate predictive precision medicine will spare children from receiving treatments that are likely to be ineffective for them and thus from exposure to unnecessary toxicity.”

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