As Clinical Director of Center for Immuno-Oncology (CIO), Combination Immunotherapy Group Dr. Strauss's clinical research is focused on the use of novel agents capable of inducing the immune system to recognize and kill cancer cells. Dr. Strauss focuses on the use of these agents in combination as well as “standard” cytotoxic therapies in an effort to improve their efficacy. Ongoing trials include the use of vaccines, immunocytokines and single or dual functioning checkpoint inhibitors (e.g. anti-PD-L1 +/- TGFbeta TRAP) either as monotherapies or in combination with each other or with cytotoxic therapies (chemotherapy, radiation). Dr. Strauss's trials enroll patients with multiple tumor types with a focus on gastrointestinal, genitourinary, gynecologic, and head and neck malignancies. Dr. Strauss also has an interest in using these therapies to help patients with the fewest treatment options, including patients with rare diseases.

Dr. Strauss has been involved in the following areas of clinical investigation: (a) In collaboration with the LTIB's CRADA partner, the laboratory is characterizing a tumor-targeting immunocytokine. NHS-IL12 is a fully human monoclonal antibody (MAb) that binds DNA/histone in necrotic tumor, which is fused to human IL-12 heterodimers. The agent was designed to reduce the toxicity of rec. IL-12 protein while maintaining its immune-enhancing properties at the tumor site. We have shown that the immunocytokine has anti-tumor activity in a range of tumor models and is extremely effective when used in combination therapies in several models. We have recently completed a first-in-human clinical trial with NHS-IL12 and are currently evaluating this cytokine in combination with anti-PD-L1 therapy. (b) The laboratory is characterizing, in collaboration with our CRADA partner, an anti-PDL1 Mab (avelumab) as well as a bifunctional fusion MAb combining an anti-PD-L1 and a TGFbeta TRAP (M7824). Unlike other anti-PD-L1 MAbs, these agents are capable of mediating antibody-dependent cell-mediated cytotoxicity (ADCC) of human carcinomas cells. We have completed a first-in-human clinical trial with avelumab, which is currently being evaluated in multiple phase III tumor specific trials and was recently FDA approved for a rare skin malignancy known as Merkel Cell carcinoma. We have also completed a first-in-human clinical trial of M7824, which is currently being evaluated in phase 1b trials in multiple tumor specific expansion cohorts. (c) In collaboration with our CRADA partners, we have initiated or plan to initiate soon first-in-human trials evaluating multiple different therapeutic cancer vaccine platforms including CV301 (rV-, rF-CEA-MUC1-TRICOM), MVA-brachyury-TRICOM, fowlpox-brachyury-TRICOM, Ad5[E1-, E2b-]-CEA, Ad5[E1-, E2b-]-MUC1, Ad5[E1-, E2b-]-brachyury, and Ad5[E1-, E2b-]-PSA.