Immune therapy against cancer by gene medicine
An immune modulator is applied by local injection of the tumor of a patient in order to activate his own immune response and to have to fight against the cancer. By gene gun devices the injection can also be systemic. The immune modulator has also antiangiogenesis efficiencies reducing blood supply to the tumor, which leads to reduced tumor growth. Furthermore, treatment for this substance increases the immune response of the patient against his tumor. These results have been analysed in several preclinical studies using tumor bearing mice which also carry metastases. Various tumors have been analysed such as malignant melanoma, renal cell -, squamous cell -, and colon carcinoma. In all these cases significant tumor reduction can be observed in mice.
In addition to mice we developed a second animal model , in which we have tested the compound, in grey horses. These animals develop with high frequency malignant melanomas and have been shown to respond to the anti-tumor therapy quite efficiently. Based on the preclinical data we have designed a clinical protocol and received approval by the Swiss authorities (Swissmedic). Furthermore, with governmental support through a KTI contract, a GMP production of the compound for human use was performed.
Based on these results an investigator-driven clinical trial has been performed at the university Hospital with KM as the sponsor and scientific coordinator without company involvement. Nine late stage cancer patients with malignant melanoma were treated with the compound at various doses and regimens. Three out of nine patients showed stationary disease, tumor reduction and one complete remission. No toxicity was detected. No adverse events were reported. Thus, the therapy is safe and also effective.
In order to improve the efficacy, combination therapies are envisaged. Several of these have already been tested in mouse models with strongly increased success rates. It is envisaged to use our compound in combination with already approved and clinically available anticancer drugs. This would reduce the extent of clinical tests.
Time for development is short, 2 years for beginning of clinical trails.
It is worth mentioning that GMP Plasmid DNA as published in our Phase I clinical trial is available for use in patients in a scientific collaboration.