In Vivo Results

Our products show potent anticancer effectiveness in challenging mouse tumor types.  Animals having a complete response become immunized against the cancer. Using mouse models of severe, late-stage pancreatic, breast, melanoma and colon cancers, our unique formulations (especially lead product INT230-6) given intratumorally (IT) were more effective with less observed toxicity than intravenous (IV) and IT dosing of the same drugs.

In early studies INT230-6 completely regressed large tumors in animals treated.  INT230-6 was able to clear completely mouse Colon26 tumors greater than 300 mm³.  In one study INT230-6 increased median overall survival of animals from 16 days with no treatment to 77 days using one 5-day cycle at a dose scalable to human tumors. Median survival using the product was also superior to the best drugs given systemically; 42 days vs. 77 days at comparable dose. Mechanism studies showed that INT230-6 induces a strong CD8+ and CD4+ mediated adaptive immune response. Ninety percent (90%) of the animals having the complete response became fully protected following subcutaneous or intravenous re-inoculation of the same cancer—a response that lasted the entire life of the animal. INT230-6 also inhibited the growth of murine breast cancer and reduced the formation of breast cancer metastases. Dual tumor modes showed injection in a primary tumor could regress distal, untreated lesions.

Our engineers developed validated assays and established GMP controlled manufacturing of INT230-6.  Clinical batches produced under GMP and tested in mice showed significantly greater efficacy than research lab produced formulations.  Using the GMP batches up to 80% of animals dosed achieved a complete response with every injected tumor regressing from baseline.

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