Kurzfassung

Small molecule Toll-like receptor (TLR) 7/8 agonists have documented efficacy as immunomodulatory drugs for the treatment of papilloma virus infection and various skin cancers by directly activating antigen-presenting cells (APC). Hence TLR7 agonists such as imiquimod have been also explored as potential vaccine adjuvants. In this context, we have characterized an imiquimod based transcutaneous immunization (TCI) method and delevoped the two novel imiquimod formulations IMI-Gel and...Small molecule Toll-like receptor (TLR) 7/8 agonists have documented efficacy as immunomodulatory drugs for the treatment of papilloma virus infection and various skin cancers by directly activating antigen-presenting cells (APC). Hence TLR7 agonists such as imiquimod have been also explored as potential vaccine adjuvants. In this context, we have characterized an imiquimod based transcutaneous immunization (TCI) method and delevoped the two novel imiquimod formulations IMI-Gel and IMI-Sol with equal or superior vaccination efficacy compared to the commercially available formulation AldaraTM in preclinical rodent models. To explore the potential of these novel imiquimod formulations in humans, we plan to conduct a clinical pilot study to evaluate tolerability and safety of IMI-Gel and IMI-Sol in comparison to AldaraTM in patients with actinic keratoses (AKs) where the treatment with AldaraTM is a standard of care in a first step. After providing favorable safety profiles for IMI-Gel and IMI-Sol, we will further develop these formulations in a second step to incorporate tumor specific target antigens for TCI of cancer patients (not part of the requested funding).
Therefore the central aim of this project is to provide evidence for the safety and tolerability of the novel imiquimod formulations IMI-Gel and IMI-Sol for the treatment of humans and to assess the suitability for the further development as a transcutaneous vaccination platform for the treatment of cancer patients.
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