Koi Biotherapeutics Inc.

Revolutionizing Car T-cell Therapy: Enhancing Activity and Persistence of Car T-cell by Developing a Car-enhancer Platform - Project Summary Chimeric Antigen Receptor (CAR) T-cell Therapy Has Achieved Notable Success in Treating Various Blood-borne Malignancies, With Six Fda-approved Therapies to Date, Including Four Targeting the CD19 Protein and Two Targeting the B-cell Maturation Antigen (bcma). Bcma Car T-cell Therapy Has Particularly Shown Promise Against Multiple Myeloma, Even in Patients With Extramedullary Lesions. However, a Significant Challenge Remains: the Durability of Response, as Most Patients Experience Relapse, Correlated With the Disappearance of Car T-cells From Circulation. Enhancing the Effector Function and Persistence of Car T-cells Is Crucial to Overcoming These Obstacles. the Car-enhancer Platform Proposes a Novel Approach to Augment the Functionality and Longevity of Car T- Cells by Promoting the Development of Memory Car T-cells. Leveraging a Protein-driven Mechanism, Car- Enhancer Obviates the Need for Specific Engineering of Car T Cells, Making It Universally Compatible and Significantly Broadening Its Therapeutic Application. With Compelling Preclinical Results, This Platform Is Poised to Revolutionize Car T-cell Therapy, Potentially Saving Lives and Advancing the Field. the Project’s Specific Aims Are Crafted to Transition the Car-enhancer Platform From Preclinical Development to Clinical Application Efficiently and Effectively. the First Aim Concentrates on Optimizing Dosing and Timing for Car-enhancer Administration in a Phase I Clinical Trial to Enhance Post-infusion Efficacy. the Second Aim Is to Establish a Scalable Manufacturing Process, Ensuring the Capability to Meet Clinical and Commercial Demands. the Third Aim Assesses the Pharmacokinetics and Toxicity Profile of Car-enhancer in Both Immunocompetent Mice and Non-human Primates, Providing Critical Safety Data for Regulatory Approval. This Initiative Aims to Expand the Reach of Car T-cell Therapies, Fostering Improved Outcomes for a Wider Range of Patients With Blood Cancers.