SAN DIEGO -- Invivoscribe Inc., a global leader in precision diagnostics and measurable residual disease (MRD) testing, supports CERo Therapeutics Holdings, Inc., an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms.

Through this collaboration, LabPMM (Invivoscribe’s global reference laboratories) have customized their multiparametric flow cytometry (MFC) services and implemented their sensitive MFC AML MRD assay to support CERo’s clinical trial of its lead compound, CER-1236. The trial targets Acute Myeloid Leukemia (AML) in patients who are relapsed/refractory, in remission with MRD, or newly diagnosed with TP53-mutated MDS/AML.

AML is an aggressive blood cancer characterized by the rapid accumulation of abnormal myeloid cells in the bone marrow and blood, disrupting normal hematopoiesis.[1] Treating AML is especially complex due to its genetic heterogeneity and the high risk of relapse. CAR-T (chimeric antigen receptor T-cells) and Chimeric Engulfment Receptor T-cells (“CER-T”) therapies, which involve engineering a patient’s own T-cells to recognize and attack cancer cells, have shown promise in other hematologic malignancies and are now being explored for AML. However, because these therapies are manufactured from patient-derived cells, it's critical to confirm that leukemic blasts are not inadvertently included in the final therapeutic product - underscoring the need for sensitive, validated assays like those offered by Invivoscribe and its global accredited regional laboratories, LabPMM.

LabPMM’s CAP/CLIA-Validated AML MRD MFC assay, which was designed to quantify residual leukemic cells in patients undergoing treatment, was customized to meet two critical needs in CERo’s drug development program: (1) assessing the purity of the manufactured T-cell product by detecting residual AML blasts prior to infusion, and (2) evaluating therapeutic response to CER-1236 during the trial.

Kristen Pierce, Ph.D., CERo Chief Development Officer, commented, “Invivoscribe has played an integral role in the execution of this clinical trial. Its technology and expertise have facilitated our advancement into the clinic by helping to ensure the purity of our investigational product, and now we are reaping the benefits of our collaboration as the trial is underway and we seek to assess therapeutic response.”

This collaborative effort was instrumental in advancing CER-1236, which recently received FDA Orphan Drug Designation for the treatment of AML[2]. The designation highlights the growing urgency of integrated diagnostic support in the advancement of personalized immunotherapies and reflects Invivoscribe’s commitment to driving innovation and standardization across the oncology treatment landscape - now helping bring immunotherapies to patients faster.