Immunicum AB (publ) announced new immunological phase I/II data showing that the majority of liver cancer patients that received full treatment with INTUVAX experience increases in the frequency of tumor-specific CD8 + T cells and that these increases directly correlate with prolonged survival rates. Highlights of the current data results: Of the eleven evaluated liver cancer patients treated with INTUVAX, nine received full treatment with three doses of INTUVAX. Five of the nine fully-treated patients have surpassed their expected median overall survival while two of three patients still alive have yet to surpass their expected median overall survival.

Assays were performed that compared the frequency of interferon-producing CD8 + T cells in the blood, indicating that the T cells have a killing function, by stimulation with two different tumor-associated antigens (antigens that can be expressed in primary liver tumors) before first INTUVAX-dose and one week after the third and final dose. Six of the nine fully-treated patients showed an increased frequency of these interferon-producing CD8 + T cells in the blood, reactive against at least one of the two tumor-associated antigens for liver cancer, after treatment with INTUVAX. For five of these six patients, an increase in the frequency of CD8+ T cells reactive against at least one of the two tumor-associated antigens for liver cancer remained at renewed analysis six weeks after the third and final INTUVAX-dose.

Four of the six patients that showed an increased frequency of these tumor-specific CD8 + T cells have surpassed their expected median overall survival and the other two patients are still alive and have not yet surpassed the expected median overall survival. Two of three fully-treated patients who did not exhibit an increased frequency of tumor-specific T cells in the blood after full INTUVAX treatment passed away before they could pass their expected median overall survival. One patient with bile duct cancer was also treated with three doses of INTUVAX and showed an increased frequency of CD8 + T cells in the blood, reactive against the two different tumor associated antigens (which may also be expressed in bile duct cancer) after full INTUVAX-treatment.

The patient also received standard treatment with gemcitabin (G), which is known to inhibit the immunosuppressive cells in tumors, in combination with cisplatin (C). This patient is still alive 26 months after the first vaccination, compared with an expected average median overall survival of 11.7 months in patients with bile duct cancer treated with G/C (Valle et al N Engl J Med 2010: 362:1273).