Gothenburg, Sweden, 2016-01-29 08:28 CET (GLOBE NEWSWIRE) —
Immunicum AB (publ) today reports a significantly improved vaccine cell handling and gives a status update from the ongoing phase II study (MERECA) with the cancer immune primer INTUVAX in patients with metastatic renal cell carcinoma. Twelve patients have thus far been included in the study. So far, no serious vaccine-related adverse events have been reported. Immunological data, based on infiltration of CD8 + T cells in the tumors and in healthy tissue, indicate a tumor-specific activation of the immune system in patients treated with INTUVAX. Necessary regulatory approvals have now been obtained to begin recruitment of patients in several European countries.
Immunicum today gave a status update from the ongoing phase II study, MERECA (MEtastatic REnal cell CArcinoma) with INTUVAX in patients with newly diagnosed metastatic renal cell cancer (NCT02432846). After approval from the Medical Products Agency, the study was initiated in Sweden already in May 2015. Twelve patients have been included in the study so far and several study-candidates have been identified for screening. No serious vaccine-related adverse events have been reported. Preliminary immunological data regarding the infiltration of CD8 + T cells in primary tumors and in healthy tissue, as well as a comparison between INTUVAX-treated patients and patients in the control group, indicate a tumor-specific activation of the immune system in INTUVAX-treated patients. Efficacy data is still too early to evaluate.
In parallel to production transfer to Eufets, a commercial GMP-certified production site in Germany, Immunicum also completed a very important adaptation of the manufacturing process. This work has on the one hand resulted in a delay in the start of the phase II study outside of Sweden but on the other hand generated a product that is ready for immediate use in the hospitals without prior preparation at local pharmacies. By significantly simplified handling of the vaccine cells, INTUVAX can in the future become available for all European clinics. Immunicum is now ready to begin recruitment of patients in several countries outside of Sweden.
– Efficacy data in the MERECA study is still too early to evaluate. However, looking at the early analyses that have been done of the tissue samples collected from the surgically removed kidneys, it looks very exciting so far. We see a very distinct tumor-associated infiltration CD8+ T cells in the examined tissue samples from the majority of patients receiving INTUVAX, says Immunicum’s Chief Scientific Officer, Alex Karlsson-Parra.
– The development of INTUVAX as a direct injectable drug is very important as it makes it possible for more clinics to take part in our studies today while at the same time broadening the market in the future, if further studies show good results. We now begin to treat patients outside of Sweden and expect that patient recruitment will really take off. All 90 patients should be able to include during this year, says Immunicum’s CEO Jamal El-Mosleh.
MERECA study design
Immunicum plans to include a total of 90 patients at 24 European centres in eight countries (Czech Republic, Spain, France, Hungary, Latvia, Poland, Sweden, and the UK). INTUVAX is injected in the primary tumor on two occasions before a surgical removal of the kidney along with the primary tumor. Patients will be randomized (randomly distributed) 2:1 between either INTUVAX in combination with sunitinib or sunitinib alone administered about six weeks after surgery. Sunitinib is a standard drug globally for treatment of renal cancer.
The study is planned to include 60 % of patients with intermediate risk prognosis and 40 % of patients with high-risk prognosis. Patients will be monitored for 18 months, with the primary objective to evaluate median overall survival in high-risk patients and 18-month survival rate in patients with intermediate risk prognosis. Secondary objectives include evaluation of the proportion of patients showing significant tumor reduction (evaluated by computer tomography/CT), progression free survival, and evaluation of CD8+ T cell infiltration in primary tumors (two separate areas), healthy kidney tissue as well as in any evaluable metastases.
After an approved protocol amendment in Sweden, all patients treated with INTUVAX will receive additional treatment with sunitinib starting six weeks after surgery. The corresponding protocol amendment has been sent to relevant local regulatory authorities in Europe. This is a change from the previous plan to allow patients with intermediate risk prognosis to wait for add-on therapy with sunitinib until CT-verified disease progression. The protocol amendment was carried out to better reflect the procedure for standard treatment, according to feedback from several clinics around Europe, and to more quickly take advantage of the potential synergistic effect when INTUVAX is combined with tyrosine kinase inhibitors that can suppress some of the inherent immunosuppression existent in tumors.
The MERECA study was preceded by a phase I/II trial (IM-101) in 11 INTUVAX-treated patients with newly diagnosed metastatic renal cell cancer and Immunicum now reports that six of the patients are still alive. The current median overall survival in the phase I/II study has currently exceeded 32 months, compared to 15.2 months based on historical data for standard treatment for the entire patient population and 28.2 months compared to 9.0 months based on historical data for standard treatment for the subgroup with poor prognosis.
For further information please contact:
Jamal El-Mosleh, CEO, Immunicum
Telephone: +46 (0) 31 41 50 52
The Company’s Certified Adviser is Redeye AB
Telephone: +46 (0) 8 545 013 31. www.redeye.se
INTUVAX is a cancer immune primer, developed for the treatment of solid tumors. Its active ingredient is activated white blood cells, so called dendritic cells, derived from healthy blood donors. Intratumoral injection of these cells is expected to lead to an inflammatory response which in turn leads to tumor-specific activation of the patient’s cytotoxic T lymphocytes.
About Immunicum AB (publ)
Immunicum AB (publ) develops cancer immune primers for the treatment of tumor diseases. A clinical phase II trial with the Company’s most advanced product – INTUVAX® against kidney cancer – has been initiated. The project portfolio contains additional clinical phase I/II studies in liver cancer and in gastrointestinal stromal tumors (GIST).