There has been some discussion about the effectiveness of HER-Vaxx in combination with SOC chemotherapy. It is certainly true that chemotherapy in killing the cancer compromises the immune system. The inference is that the study itself is compromised in that the efficacy of HER-Vaxx will be masked by the damaging effect of the chemotherapy. If this were true I doubt whether Herceptin would ever have been approved given that HER-Vaxx and Herceptin target the same receptors.
How to make sense of it. The countervailing effect of the chemotherapy is taken into account in reading the data. The investigators will interrogate the data for evidence of safety and tolerability, proof in regards to the mechanism of action as well testing the hypothesis that administration of IMU-131 in addition to chemotherapy will prolong survival and may delay tumor progression and/or reduce tumor burden in patients.
Indeed, Imugene may establish in later studies that HER-Vaxx may work better without combination with chemotherapy. What has been established is that in breast cancer pre-clinical studies, the combination with Herceptin shows significantly higher inhibition than Herceptin alone. Many thanks for the discussion around this point.
The scientific community will know how to connect the dots and Imugene will helpfully direct their analysis. HER-Vaxx could well generate the capital required to progress later trials involving CF33. Imugene can't keep it all inhouse but it would be wonderful to have the opportunity to progress at least one candidate through to drug approval.
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