Gothenburg, 2015-11-17 14:00 CET (GLOBE NEWSWIRE) —
Immunicum AB (publ) today announced continued data improvement from the follow-up phase of a phase I/II-trial in eleven patients with metastatic kidney cancer that started in February 2012. Six patients are still alive and the data show an ongoing, close to doubled median overall survival for the entire patient group and an ongoing right now tripled median overall survival for patients with poor prognosis compared to published historical data for newly diagnosed patients who received standard treatment.
Immunicum’s Chief Scientific Officer, professor Alex Karlsson-Parra, today presents, at the Immune Checkpoint Inhibitors Europe conference, updated survival data from the Company’s phase I/II study in patients with metastatic kidney cancer treated with the cancer immune primer INTUVAX. Six (6) of the eleven (11) evaluable patients are still alive. Median overall survival for the entire patient population currently stands at 29.8 months versus expected 15.2 months (historical data on newly diagnosed patients with metastatic renal cancer treated with the tyrosine kinase inhibitor Sutent/sunitinib). For the group with high-risk prognosis (6 patients), the median overall survival is currently at 27 months versus expected nine (9) months and for patients with intermediate prognosis (5 patients), the median overall survival is currently at 35.2 months versus expected 26 months. The final median overall survival has not yet been reached for any of the three patient groups.
– Regarding the expected mechanism of action to explain these promising survival data, obviously the high infiltration of CD8+ T cells that we observed in the majority of treated primary tumors in the phase I/II study is very exciting as these findings suggest that INTUVAX has succeeded in mobilizing a specific immune response against the cancer. We therefore believe that INTUVAX has the potential to act synergistically in combination with other treatments, such as tyrosine kinase inhibitors or checkpoint inhibitors, which may dampen the immunosuppression inherent in the tumors. Six of the eleven patients have received additional treatment with some type of tyrosine kinase inhibitor and in some cases where these patients have had strong or massive intratumoral infiltration of potentially tumor killing T cells, we also believe that we see a synergistic anti-tumor effect after add-on treatment with tyrosine kinase inhibitors. Overall survival data looks very good but we want to emphasize, however, that the patient population is small and it is not possible to draw any conclusions that similar results will be achieved in our ongoing phase II study, says Immunicum’s Chief Scientific Officer, professor Alex Karlsson-Parra.
– We also believe that the immunological anti-tumor effect may, at least partially, be due to activation of other immune cells, including tumor suppressive macrophages. For example, we have a patient with minimal intratumoral infiltration of CD8+ T cells but with scattered accumulations of macrophages in the tumor. After surgery of the kidney tumor and local metastases, a small metastasis remained that during a shorter period of time increased in size but which has subsequently been in complete regression. That is, the patient is now completely tumor free, and this despite the fact that no subsequent treatment with tyrosine kinase inhibitors has been initiated. Although in the literature there are cases described of spontaneous regression in renal cell cancer, this is extremely rare with less than one percent of cases, continues Immunicum’s Chief Scientific Officer, professor Alex Karlsson-Parra.
– Data continues to mature very positively and the current median overall survival for all patient groups is beginning to look overwhelmingly good. We look forward to collecting initial data from the ongoing phase II study around the turn of the year and we expect to be able to report especially immunological data, says Immunicum’s CEO, Jamal El-Mosleh.
The purpose of the phase I/II study was to document the safety profile and immunological effects, as well as to follow the survival of patients with metastatic renal cell cancer after two INTUVAX treatments.
For further information, please contact:
Jamal El-Mosleh, CEO, Immunicum
Phone: +46 (0) 31 41 50 52
The company’s Certified Adviser is Redeye AB
Phone: +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 phase II clinical trial for the Company’s most advanced product – INTUVAX® against kidney cancer – has been initiated. The project portfolio contains an additional clinical study in liver cancer and an upcoming clinical phase I/II-study in gastrointestinal stromal tumors (GIST).