Irazú Oncology is advancing a pipeline of OMV-based immunotherapies designed to activate both innate and adaptive immune responses against cancer. Our programs are engineered to combine potent antigen-specific immunity with tumor microenvironment remodeling in scalable, off-the-shelf therapeutics.
Design
Preclinical
Phase 1
Phase 2
Phase 3
IRZ-03
Checkpoint Inhibitor–Refractory Solid Tumors Including Colorectal, Non-Small Cell Lung, Gastric, Pancreatic, and Head and Neck Cancers
IRZ-03 is a first-in-class OMV immunotherapy that attacks solid tumors on two fronts in a single off-the-shelf agent. It directs the immune system against the tumor-associated antigens CEA and MUC1 while simultaneously targeting PD-L1 on the immunosuppressive cells that disarm anti-tumor immunity.
This dual mechanism is purpose-built for the patients checkpoint inhibitors leave behind. Rather than blocking the PD-1/PD-L1 axis alone, IRZ-03 is designed to drive immune-mediated clearance of the PD-L1–expressing myeloid and dendritic populations — tumor-associated macrophages, MDSCs, and suppressive dendritic cells — that sustain an immunosuppressive microenvironment, while generating new antigen-specific immunity against the tumor itself.
IRZ-03 is engineered to:
- Generate coordinated antigen-specific T-cell and B-cell responses against CEA and MUC1
- Clear PD-L1⁺ immunosuppressive cells to dismantle the tumor’s defense against immune attack
- Establish durable immunologic memory to guard against recurrence
The program is in IND-enabling development, advancing on a regulatory path informed by FDA Pre-IND feedback.
Preclinical Validation
Proof-of-concept studies with IRZ-01, our first-generation OMV construct, achieved 100% durable, tumor-free responses, with complete resistance to tumor rechallenge five months after treatment in syngeneic models — evidence of long-lived protective immunity. IRZ-03 builds directly on this validated platform architecture.
Platform Expansion
Undisclosed Programs
Beyond IRZ-03, the Irazú OMV platform supports rapid development of additional immunotherapies through proprietary antigen-conjugation technology and scalable bacterial fermentation manufacturing. The company is actively engaging pharma and biotech partners on platform collaborations targeting indications beyond our internal pipeline
Additional Areas Under Consideration
- Vaccines for infectious diseases (e.g. pan-Sarbecovirus vaccine)
- Women’s Health (e.g. Endometriosis)
- Potentiation of the Abscopal Effect of Radiation Therapy