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Developed via Codiak’s proprietary engEx Platform, exoIL-12 is designed to generate local and systemic anti-tumor activity without systemic drug exposure. Historically, preclinical and clinical studies of IL-12 have shown a potent anti-tumor immune-response as a single agent through activation of T cells and NK cells. While the biological rationale for IL-12 as a cancer treatment has been encouraging, its utility has been severely limited due to an inability to consistently retain IL-12 locally and manage potentially serious adverse events caused by systemic exposure. In Codiak’s preclinical studies, the anti-tumor immune activity with exoIL-12 allowed for reduced IL-12 doses to achieve local and systemic tumor shrinkage and showed dose dependent injection-site retention and no measurable systemic exposure of IL-12.

We are developing exoIL-12 for the treatment of solid tumors that contain T cells and NK cells and where engagement of the IL-12 pathway has been well-characterized, such as cutaneous T cell lymphoma, melanoma, Merkel cell carcinoma, Kaposi sarcoma, glioblastoma multiforme, and triple negative breast cancer. The initial focus of our development efforts is on early stage cutaneous T cell lymphoma.

We have initiated a Phase 1 clinical trial for exoIL-12 in healthy volunteers and patients with early stage cutaneous T cell lymphoma and plan to expand into other IL-12 responsive solid tumors in the future.

See the Science

exoIL-12: Dose-Dependent Tumor Growth Inhibition and Systemic Tumor Antigen-Specific Immune Response

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Comparison of anti-tumor activity of exoIL-12 and recombinant IL-12. exoIL-12 showed dose-dependent effects on tumor growth at all dose levels, immunological memory upon re-challenge, and antigen-specific immune response.
Chart exo IL12 1 desktop
Comparison of anti-tumor activity of exoIL-12 and recombinant IL-12. exoIL-12 showed dose-dependent effects on tumor growth at all dose levels, immunological memory upon re-challenge, and antigen-specific immune response.

exoIL-12: GLP Tox NHP Data Support Tissue Retained Pharmacology

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Pharmacokinetics and pharmacodynamics following subcutaneous administration of exoIL-12 demonstrating retention of the exoIL-12 at the injection site and local pharmacological activity with minimal leakage into blood circulation.
Chart exo IL12 2 desktop
Pharmacokinetics and pharmacodynamics following subcutaneous administration of exoIL-12 demonstrating retention of the exoIL-12 at the injection site and local pharmacological activity with minimal leakage into blood circulation.