Pilot Acute Safety Evaluation of Innocell™ Cancer Immunotherapy in Canine Subjects

Abstract

Background. We are developing cancer immunotherapy based on the use of autologous tumor tissue that has been rendered replication-incompetent but maintains phenotype and metabolic activity post-preparation. Aim. The aim of this study was to evaluate safety and tolerance to injection of the inactivated tumor cell and adjuvant preparation (Innocell™) within 24 hours of administration in a pilot study in canine patients with solid organ tumors. Methodology. Three canine patients demonstrating accessible solid organ tumors of various types were assessed in this study. The local site injection was monitored post-treatment. Clinical signs of adverse reactions were monitored for 24 hours post-treatment. Blood samples were taken pre-treatment and at 8 and 24 hours post-treatment for all subjects. One subject provided samples at 7 days post-treatment. All blood samples were analyzed for cytokine content for both immune system-associated and tumor-associated cytokines. Results. No signs of adverse reactions at the site of injection or systemically were observed in the study period. A slight fever and lethargy were reported in one subject by the owner post-vaccination. Immune system-associated cytokine levels in two of the three animals were elevated post-treatment. Tumor-associated cytokine levels in all three subjects declined post-treatment from baseline levels with the effect most prominent in the subject with a non-excised tumor. Conclusion. Subcutaneous injection of the inactivated tumor cells and adjuvant was well tolerated in this pilot study. Cytokine responses observed were in line with the intended use of the treatment in stimulating immune response without adverse clinical observations. Additional evaluation is warranted.

A Whole Virion Vaccine for COVID-19 Produced via a Novel Inactivation Method and Preliminary Demonstration of Efficacy in an Animal Challenge Model

“…Importantly, we believe that this initial work demonstrates the potential that such a production method could be applied to vaccine candidates targeting other viral, bacterial, and parasitic pathogens. We have already applied such an approach to the generation of solid tumor vaccines and evaluated their use in both murine and canine disease models [ 34 , 35 ]. Results from studies involving vaccine, boost and challenge material with different levels and types of spike variants demonstrate the broad responsiveness that a vaccine candidate prepared via this method may have relative to emerging variants.…”

A whole virion vaccine for COVID-19 produced via a novel inactivation method: results from animal challenge model studies

“…Importantly, we believe that such a production method could be applied to vaccine candidates targeting other viral, bacterial, and parasitic pathogens. We have already applied such an approach to the generation of solid tumor vaccines and demonstrated their use in both murine and canine disease models [24,25].…”

Elucidating tumor immunosurveillance and immunoediting: a comprehensive review

“…Adding, one of the oldest techniques involves vaccines, making it an attractive method due to its practicality and ease of preparation, using several primary sources, which resulted in the offer of several tumor vaccines for dogs, however, missing comprehensive clinical studies (72) . The use of autologous vaccines has shown similar and satisfactory responses when compared to conventional treatments, as evidenced by preliminary studies in canine patients with hepatocellular carcinoma, mast cell tumor, sarcoma of soft tissue (73) , metastatic hemangiosarcoma (74) , and osteosarcoma (75) .…”