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Notable Labs Presents Data Demonstrating PPMP’s Potential to Identify Novel Drug Combinations in JMML at the 2023 EHA Hybrid Congress

– Data demonstrates Notable’s PPMP potential in selecting more active investigational pre-hematopoietic stem cell therapy drug combinations, as compared to regimens currently used in JMML – FOSTER CITY, Calif., June 9, 2023 – Notable Labs, Inc. (“Notable”), a clinical stage therapeutic platform company developing predictive precision medicines for cancer patients, today presented data from an […]

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Prediction of clinical response to venetoclax plus decitabine in AML using a 7-day ex vivo assay

The combination of venetoclax (VEN) and a hypomethylating agent (HMA) such as decitabine (DEC) is frequently used in acute myeloid leukemia (AML) for patients unfit for standard chemotherapy. However, there is a subset of patients who do not clinically respond to such combination therapies. To identify VEN + HMA non- responders prior to treatment we developed an assay on our automated, high throughput (HTS) ex vivo drug sensitivity platform to predict how a given patient will clinically respond to DEC + VEN within an ongoing, open label, phase II clinical trial (NCT03404193) for patients with newly diagnosed elderly/unfit or relapsed/refractory (R/R) AML.

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Ex Vivo Drug Sensitivity Assay Correlates with Clinical Response and Identifies Panobinostat and Bortezomib as a Potential Novel Drug Combination for Pediatric AML

Pediatric acute myeloid leukemia (AML) is a rare disease with roughly 600 cases diagnosed in the United States each year with minimal improvement in clinical outcomes over the last few decades. Diagnostic pediatric AML samples were assayed using an ex vivo drug sensitivity test to determine the correlation between ex vivo drug response and clinical outcome, and to compare conventional chemotherapy to other drug combinations ex vivo.

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Ex vivo drug sensitivity assay correlates with clinical response in pediatric AML

Listen to the exciting results from Notable's collaboration with Texas Children's Cancer Center highlighting response prediction in a pediatric acute myeloid leukemia (AML) study that was presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. The data was presented by Dr. Alexandra Stevens from Texas Children's and demonstrates the correlation of functional drug sensitivity screening using Notable’s predictive technology platform with the clinical outcomes of pediatric patients.

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SY-1425, A Potent and Selective RARA Agonist, Reprograms AML Cells for Differentiation Along Distinct Lineages Uncovering PD Markers for Clinical Studies

A subgroup of the patient samples was defined by an SE driving RARA, which co-occurred with SEs driving FOS and JUNB, or IRF8. FOS and JUNB form the AP-1 heterodimeric TF known to promote an immature cell state and the interferon regulatory factor 8 (IRF8) pathway has been implicated in AML pathogenesis.

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Pharmacodynamic and pharmacokinetic evaluation of SY-1425 (tamibarotene) in biomarker-selected acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients

SY-1425 (tamibarotene) is an oral, potent and selective synthetic RARα agonist previously approved for the treatment of relapsed/refractory acute promyelocytic leukemia (APL) in Japan. Given preclinical evidence of SY-1425 sensitive AML cell lines and patient samples with RARA pathway activation defined by elevated RARA or IRF8, SY-1425 is being...

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RARA Pathway Activation Biomarkers in Study SY-1425-201 Define a New Subset of AML and MDS Patients and Correlate with Myeloid Differentiation Following Ex Vivo SY 1425 Treatment

We developed an epigenetic approach to profile the gene regulatory landscape of primary AML/MDS patient samples. A novel patient subset defined by RARA pathway activation was identified by super-enhancers (SEs) at the RARA and IRF8 gene loci.

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Early Results from a Biomarker-Directed Phase 2 Trial of SY-1425 in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Demonstrate DHRS3 Induction and Myeloid Differentiation Following SY-1425 Treatment

Bone marrow biopsies (H&E) at 40x from screening (A) and C3D1 (B). Bone marrow aspirate (WG stain) at 100x from screening (C) and C3D1 (D). (A) Blasts (black arrows) occur in many small groups. Maturing myeloid cells (yellow arrows), erythroid precursors (red arrows) and megakaryocytes (blue arrows) are also present.

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Successful Treatment with Bortezomib, Panobinostat, and Dexamethasone of Acute Myeloid Leukemia (AML) in 2nd Relapse After Allogeneic Stem Cell Transplantation (SCT): Therapy Selected Based Upon Results of a Personalized Flow Cytometric Screen for Drug

Notable Labs uses a flow cytometric-based assay to test a panel of FDA-approved chemotherapy and targeted agents—singly and in combinations using a custom robotic platform—to determine anti-cancer effect against individual patient’s tumor cells.