Technological disruption it will be, since combinations of immunotherapy are the paths to an approach for the fight on a tumor, but a vehicle is needed for helping with synergetic efficacy and lowering the toxicity and disruption of the immune system. Electroporation of IL-12 is taking care of that.
Reading the first report of electroporation-mediated IL-12 gene therapy done back in 2001, signs of the cytokine's importance was already proven by the eradication of established murine tumors and their metastases, leading to the generation of tumor-specific immunological memory. However, in the first clinical trial, IL-12 protein therapy resulted in the death of 2 patients and led to severe toxic effects in 15 others. http://cancerres.aacrjournals.org/content/61/3/1005
Sixteen years later Oncosec shows results of electroporation IL-12 in a combination therapy with Keytruda, the most important immunotherapy to date. The study yielded a 50% best overall response rate at 24 weeks, with 42.9% of the cohort reaching RECIST v1.1 response. The combination resulted in 41% of patients who were diagnosed as non-responders becoming complete responders, 9% had a partial response, and 9% had stable disease. This accounted for a total disease control rate of 59%. The serious adverse event rate in the combination study was 8.7% with no life-threatening or grade 4 adverse events. That's pretty amazing when compared to other present studies which are not utilizing an assay for assessing the non responders like Oncosec is doing.
I found this article that was published days after Oncosec's results got released. Researchers identify a molecule p40 monomer which is a member of IL-12 group of proteins that facilitate communication between cells that helps cancer stay alive. "The team saw that when p40 levels dropped, cancer cells died (though lung cancer cells were not affected), and prostate tumors treated with the MAB in the corroborating mouse model shrank significantly. Levels of interferon-gamma (IFN-gamma) protein, which is capable of killing tumor cells on its own, also rose sharply." https://medicalxpress.com/news/2017-10-molecule-cancer-alive-antibody-therapy.html
This is very good news for Oncosec as it shines a light on the importance of IL-12 cytokine and helps to show why they are on the correct path. The scientist are hoping to bringing p40 to clinical trials but it will take a few years for that. In the mean time Oncosec has fast track designation and will look to qualify for expedited FDA review, and a rolling Biologics License Application (BLA)
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