CERo Therapeutics Holdings, Inc. has commenced clinical trials for its lead product candidate CER-1236, a novel engineered T-cell therapy that employs phagocytic mechanisms to target acute myeloid leukemia (AML). The Phase 1 trial is supported by specialized diagnostic services from Invivoscribe Inc., a global leader in precision diagnostics and measurable residual disease (MRD) testing.
The clinical trial targets AML patients across multiple disease states: those who are relapsed/refractory, patients in remission with MRD, and newly diagnosed individuals with TP53-mutated MDS/AML. AML represents an aggressive blood cancer characterized by the rapid accumulation of abnormal myeloid cells in the bone marrow and blood, disrupting normal hematopoiesis. The disease presents significant treatment challenges due to its genetic heterogeneity and high risk of relapse.
Novel CER-T Technology Platform
CERo's proprietary approach to T-cell engineering distinguishes itself from conventional CAR-T therapies through its integration of both innate and adaptive immunity characteristics. The company's Chimeric Engulfment Receptor T-cells (CER-T) are designed to redirect patient-derived T cells to eliminate tumors by incorporating engulfment pathways that employ phagocytic mechanisms to destroy cancer cells.
According to the company, this differentiated activity of CER-T cells is expected to afford greater therapeutic application than currently approved CAR-T cell therapies. The platform's design potentially enables treatment across both hematological malignancies and solid tumors, representing a significant expansion of therapeutic scope compared to existing engineered T-cell approaches.
Critical Diagnostic Support
Invivoscribe's LabPMM global reference laboratories have customized their multiparametric flow cytometry (MFC) services and implemented their sensitive MFC AML MRD assay to support the CER-1236 clinical trial. The collaboration addresses two critical needs in CERo's drug development program: assessing the purity of the manufactured T-cell product by detecting residual AML blasts prior to infusion, and evaluating therapeutic response to CER-1236 during the trial.
The diagnostic support is particularly crucial because CAR-T and CER-T therapies are manufactured from patient-derived cells, making it essential to confirm that leukemic blasts are not inadvertently included in the final therapeutic product. LabPMM's CAP/CLIA-Validated AML MRD MFC assay was specifically designed to quantify residual leukemic cells in patients undergoing treatment.
"Invivoscribe has played an integral role in the execution of this clinical trial," commented Kristen Pierce, Ph.D., CERo Chief Development Officer. "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."
Regulatory Recognition
The collaborative effort has been instrumental in advancing CER-1236, which recently received FDA Orphan Drug Designation for the treatment of AML. This designation highlights the growing urgency of integrated diagnostic support in the advancement of personalized immunotherapies and reflects the clinical potential of CERo's novel approach.
The Orphan Drug Designation provides regulatory incentives for the development of treatments for rare diseases, acknowledging the significant unmet medical need in AML treatment. This recognition supports the continued development of CER-1236 as a potential therapeutic option for patients with limited treatment alternatives.
Expanding Immunotherapy Horizons
While CAR-T therapies have shown promise in other hematologic malignancies and are now being explored for AML, CERo's CER-T platform represents a next-generation approach that aims to engage the body's full immune repertoire for optimized cancer therapy. The integration of phagocytic mechanisms into engineered T-cell therapeutics represents a novel strategy that could potentially address some of the limitations observed with current CAR-T approaches.
The ongoing clinical trial will provide critical data on the safety and efficacy of this innovative therapeutic approach, potentially establishing a new paradigm for engineered T-cell therapies in oncology treatment.
