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Unlocking the Full Potential of Cancer Immunotherapy

Exeliom Biosciences is a clinical-stage biotechnology company developing EXL01, a first-in-class therapy designed to overcome resistance to immune checkpoint inhibitors (ICIs).

Many tumors fail to respond to checkpoint blockade because early innate immune signals are suppressed. EXL01 addresses this bottleneck by reprogramming immunosuppressive macrophages into pro-inflammatory, tumor-fighting cells through targeted activation of the NOD2–CARD9 pathway, restoring the immune signals required for effective anti-tumor responses.

By strengthening the innate–adaptive immune axis, EXL01 aims to increase the depth and durability of responses to immunotherapy.

The lead program is a randomized Phase 2 trial in first-line advanced gastric cancer, with additional studies underway in lung, liver, and renal cancers.

Breaking the Immunotherapy Ceiling

Immune checkpoint inhibitors have transformed cancer therapy, but many patients still fail to respond or relapse quickly.

In many tumors, the problem is not the checkpoint inhibitor itself.

It is the absence of early innate immune signals required to activate effective anti-tumor T-cell responses.

This innate immune dysfunction prevents many patients from benefiting fully from immunotherapy.

EXL01: Reprogramming Macrophages to Restore Immunotherapy Response

EXL01 is a first-in-class oral immunomodulator designed to restore the innate immune signals required for effective checkpoint inhibitor therapy.

Derived from the commensal bacterium Faecalibacterium prausnitzii, EXL01 activates the NOD2–CARD9 signaling pathway, triggering metabolic reprogramming of macrophages.

This converts immunosuppressive macrophages into pro-inflammatory, tumor-fighting cells, strengthening antigen presentation and enabling stronger T-cell responses.

By restoring this innate-adaptive immune axis, EXL01 aims to increase the depth and durability of responses to immune checkpoint inhibitors.

DISCOVER EXL01’s MACROPHAGE-TARGETED MECHANISM

It plays a dual role in regulating macrophages activation and polarization between M1 and M2 phenotypes.

Advancing a Multi-Trial Oncology Program

EXL01 is currently being evaluated across multiple clinical trials in oncology.

The lead program is the BIG randomized Phase 2 study in first-line advanced gastric cancer, evaluating EXL01 in combination with nivolumab and chemotherapy.

Additional studies are exploring EXL01 as an adjunct to immunotherapy in:
• Non-small cell lung cancer
• Hepatocellular carcinoma
• Renal cell carcinoma

Together, these trials aim to establish EXL01 as a novel innate immune primer capable of expanding the responder pool to checkpoint inhibitors.

Partnering Opportunities

Exeliom is actively engaging with pharmaceutical partners interested in advancing next-generation immunotherapies and microbiome-derived medicines.

For partnership discussions or investor inquiries, please contact: Benjamin Hadida, bhadida@exeliombio.com

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