Press release
130520 

Immunicum AB (publ) presents a status update with promising data from an ongoing clinical phase I/II-study of the cancer vaccine INTUVAX™ in the treatment of metastatic renal cell carcinoma. Two patients with poor prognosis have thus far shown an average survival of about 11 months, which can be compared to the expected median survival of 5 months.
 

Immunicum AB (publ), a Swedish listed company developing therapeutic cancer vaccines, initiated a clinical phase I/II-study in renal cell carcinoma with its leading cancer vaccine INTUVAX™ in February 2012. On May 21, Immunicum’s CEO gives an update of clinical data at Avanza Bank's Stock Exchange Day.

The clinical trial will include a total of 12 patients with metastatic renal cell carcinoma of which 9 have been treated to date. The treatment consists of two intratumoral injections/vaccinations with INTUVAX™ every two weeks, after which the cancerous kidney is surgically removed.

All treated patients are still alive and injection of INTUVAX™ has not had a negative impact on patients' general condition and no serious side effects have been reported. No patients have so far been considered in need of additional treatment with established kidney cancer drugs.

One of the patients belonging to the subgroup with poor prognosis has so far demonstrated a progression-free survival exceeding 8 months, compared with an expected progression-free survival of approximately 2.5 months in untreated patients in a comparable prognosis group.

- Although we still can not be sure of the vaccine efficacy, the data that has been gathered so far is looking promising", says CEO Jamal El-Mosleh.  INTUVAX™ also seems to be free from the troublesome side effects such as extreme fatigue, nausea, vomiting, painful mouth ulcers and hypertension, which are frequent in the treatment with established drugs for kidney cancer.

For the four patients treated with a higher dose of INTUVAX™, a statistically significant (P <0.01) immunological effect, associated with vaccination, has been observed in the form of a transient decrease in the number of "natural killer cells" (NK cells) in the blood. This suggests that NK cells are recruited to the vaccination site. Furthermore, immunohistological studies revealed a massive infiltration of potentially cytotoxic T cells (CD8 + T cells) in 3 out of 7 treated renal tumors (surgically removed in connection with nephrectomy). However, no increased infiltration of CD8 + cells were observed in the surrounding healthy kidney tissue, indicating that infiltration, and the immune response, is tumor-specific. The infiltration of CD8 + T cells in a resected metastasis has also been studied where a significant infiltration of these cells in the tumor tissue has been noted, indicating that the immune response has effect throughout the entire body and not just locally in vaccinated tumors.

- These immunological findings correspond well with the expected mechanism of action, says Immunicum’s Chief Scientific Officer and founder, Associate Professor Alex Karlsson-Parra.

Immunicum’s patented vaccine is based on over 30 years of research in the field of transplantation immunology and activates the body's own immune system to attack harmful substances like tumor cells. Immunicum’s shares have been traded since April 22, 2013 at NASDAQ OMX First North under the ticker IMMU.

G&W Fondkommission is chosen as the Company’s Certified Adviser.

Tel: +468-503 000 50. www.gwkapital.se.

For further information please contact:

Jamal El-Mosleh, CEO of Immunicum, 0703-31 90 51, jamal.elmosleh@immunicum.com

About Immunicum AB (publ):
Immunicum AB (publ) develops cancer immunotherapies. Its two main groups of therapeutic cancer vaccines, SUBCUVAX™ and INTUVAX™, and the method of expansion of tumor-specific T-cells (CD70) is based on the Nobel prize awarded discovery of the dendritic cell and its central role in the activation of the specific immune response. Because the raw material consists of dendritic cells from healthy donors, Immunicum’s products can be produced in large scale. The vaccines have earlier proven efficacy in animal studies and are now undergoing clinical trials in patients.