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

Foster City, Calif., December 16, 2021 – 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 predicitive 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.”

The meeting was held virtually and in person in Atlanta, GA, from December 11-14, 2021.

The posters are available for viewing on Notable’s website: https://notablelabs.com/category/scientific-poster/

For more details about the ASH Annual Meeting please visit: https://www.hematology.org/meetings/annual-meeting

About Notable

Notable is a clinical-stage platform therapeutics company designing and delivering predictive precision medicines, a new class of medicines. Notable aims to be the leader in predictive precision medicine and revolutionize the way in which patients seek and receive treatments that work best for them – patient by patient, and cancer by cancer. By transforming historical standards of care, Notable expects to provide dramatic impact for patients and the healthcare community.

Notable’s proprietary predictive precision medicines platform bio-simulates a patient’s cancer treatment and predicts whether a patient will respond to a specific cancer treatment.

Using its high-fidelity platform, Notable can identify and select clinically responsive patients prior to their treatment and fast-track clinical development in this patient population. Notable has created a targeted, triple de-risked in-licensing strategy to deliver a product’s medical impact and commercial value faster, higher, and more likely than traditional drug development.

Investors in Notable include B Capital Group, Lifeforce Capital, Builders VC, Founders Fund, Lightspeed Venture Partners, Y Combinator, First Round Capital as well as 11.2 Capital, Refactor Capital, Upside Partnership, and Fuel Ventures.

Notable is headquartered in Foster City, California. Learn more at www.notablelabs.com and follow us @notablelabs.

Contact

Caroline Bone

Notable Labs
communications@notablelabs.com

415-851-2410