Irazú Oncology is engaging pharma and biotech partners on two distinct opportunities: clinical co-development of its lead candidate, IRZ-03, and collaborations leveraging its modular OMV platform to address indications beyond the company’s internal pipeline.
OMV Platform Partnering Opportunities
Irazú Oncology is advancing a new class of off-the-shelf cancer immunotherapies built on a proprietary outer membrane vesicle (OMV) platform. Each construct packages tumor antigens and immune-activating signals into a single self-adjuvanted particle — engineered to mobilize both innate and adaptive immunity, including in patients who fail to respond durably to checkpoint inhibitors.
The platform’s advantage is breadth with speed: a common, manufacturing-ready vesicle backbone that accepts new antigen combinations without re-engineering the product from scratch, paired with scalable bacterial fermentation. It builds on more than 15 years of OMV research originating at the University of Maryland’s Center for Vaccine Development and Global Health, and is backed by FDA Pre-IND alignment on key regulatory elements for our lead program.
We are engaging strategic partners on both asset-level and platform-level opportunities — from co-development of our lead program to applying the platform against targets and indications beyond our internal pipeline.
Why Partner with Irazu Oncology
- De-risked regulatory path: IRZ-03 enters IND-enabling studies with FDA Pre-IND alignment already secured on the questions that stall early programs — species selection, potency assay (MAT), dosing, and PK/biodistribution methodology. The path to the clinic is defined, not theoretical.
- Three mechanisms, one construct: A single self-adjuvanted product delivers what typically requires a combination regimen — antigen-specific T-cell and B-cell priming, clearance of the immunosuppressive cells that blunt anti-tumor immunity, and durable immunologic memory. One agent, one manufacturing process, none of the regulatory and IP complexity of combining separate drugs.
- Off-the-shelf by design: Bacterial fermentation enables scalable, cost-effective supply with no patient-specific manufacturing — sidestepping the cost, delay, and logistics that constrain personalized neoantigen approaches.
- A platform, not just an asset: Proprietary antigen-conjugation technology allows tumor targets to be swapped or combined on a common backbone, turning a partner’s indication into a development program rather than a research project.
- Proven leadership: A team behind 50+ IND submissions and multiple commercial-stage successes, with decades of drug development experience across major pharma and biotech.
IRZ-03 Clinical Co-Development Opportunity
IRZ-03 is a first-in-class OMV immunotherapy that attacks solid tumors on two fronts in a single off-the-shelf agent — directing the immune system against the tumor antigens CEA and MUC1 while targeting PD-L1 on the immunosuppressive cells that disarm anti-tumor immunity. It is purpose-built for the patients checkpoint inhibitors leave behind: colorectal, non-small cell lung, gastric, pancreatic, and head and neck cancers.
Status:In late-stage preclinical development, with FDA Pre-IND alignment secured on key regulatory elements.
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. IRZ-03 builds directly on this validated platform architecture.
Partnership structures under consideration: Co-development with option to acquire, regional rights, or full asset license — each designed to align partner investment with program de-risking milestones through IND, Phase 1a, and Phase 1b.
IRZ-03 is the most advanced expression of Irazú’s OMV platform, engineered to convert the platform’s intrinsic immune-activating properties into a precise, potent, and manufacturable therapeutic. Where checkpoint inhibitors release one brake on the immune system, IRZ-03 is built to do more — generate new antigen-specific immunity and dismantle the tumor’s immunosuppressive defenses in a single construct — offering a partner a differentiated mechanism in the large and underserved CPI-refractory setting.
Engage with Us
We welcome inquiries from pharma and biotech business development teams, scientific partnering leads, and corporate venture groups.
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