Based on previous clinical trial data, Vaccinogen’s ACTIVE Phase IIIb trial will only treat patients with stage II disease. However, Vaccinogen plans to conduct a pilot program in parallel with ACTIVE to evaluate OncoVAX® in combination with an adjuvant chemotherapy treatment. During surgery for colon cancer, it is not immediately clear whether a patient has stage II or stage III disease. Consequently, some tumors will be processed into a vaccine prior to the staging process. Although not part of ACTIVE, we want to determine the best way to utilize OncoVAX® to treat stage III patients with a combination therapy.
Any vaccination protocol needs to accommodate the adjuvant chemotherapy treatment given to stage III colon cancer patients post-surgery. There is a risk that the immunosuppression commonly observed during chemotherapy treatment could interfere with the efficacy of OncoVAX®.
To address this concern, our pilot trial will have delayed-type hypersensitivity (DTH) and safety endpoints to determine whether the required chemotherapy treatment interferes with the immunogenicity of the vaccine. This trial will enroll 30 patients and is planned to start one month after ACTIVE. DTH data will become available for the patients when they receive their third immunization, which is expected to be administered before their chemotherapy begins. Full data from this trial could be available within eighteen months after beginning ACTIVE. A successful outcome of this study could pave the way for a larger study and ultimately FDA-approval for OncoVAX® in stage III disease.