Immunicum Posts Positive Cancer Vax Data

Immunicum AB has posted positive survival data from a Phase I/II study of the therapeutic cancer vaccine Intuvax for the treatment of metastatic renal cancer. The study, initiated in February 2012, includes a total of 12 patients, each treated with two intratumoral injections/vaccinations with Intuvax, two weeks apart, after which their cancer-affected kidney, as part of the standard treatment, was surgically removed.

Vaccination with Intuvax did not have any negative impact on patients’ general condition and no serious vaccine-related adverse events have been reported.

Median overall survival after vaccination for the subgroup of five patients with poor prognosis (subgrouping according to generally accepted so-called Heng-criteria) is currently at eight months and has thus already exceeded the expected median overall survival of five months with interferon treatment and 7.8 months with modern targeted therapies.

Three of the five patients in the poor prognosis group also have an unusual tumor type that impairs the prognosis further. Median survival in these three patients is currently at six months from the time of diagnosis compared to the expected three months. Two of five patients in the poor prognosis group currently have survived for more than 15 months after vaccination, and both are still alive. These figures can be compared with an expected 15-month survival rate of approximately 15% in patients with poor prognosis who are treated with interferon and about 25% in patients treated with targeted therapies.

The observation period is too short to draw any conclusions about how the median overall survival in the subgroup with intermediate prognosis (seven patients) stands in relation to the expected median. Two patients have already passed the expected median survival of 14 months for patients treated with interferon. The first patient treated has now survived for almost 22 months after vaccination and has not required any further treatment.

Looking at the entire patient population of 12 patients, 10 patients are still alive. The company will continue to monitor survival data after the final study report has been submitted to the Medical Products Agency, which is expected in 1Q14.