Immunicum reports preliminary regression data after add-on therapy with tyrosine kinase inhibitors and continued compelling survival data from the formally completed phase I/II-study in renal cell ...

Immunicum reports preliminary regression data after add-on therapy with tyrosine kinase inhibitors and continued compelling survival data from the formally completed phase I/II-study in renal cell carcinoma

Gothenburg, Sweden, 2014-05-21 13:44 CEST (GLOBE NEWSWIRE) -- In addition to continued convincing survival data from the formally completed phase I/II-study in metastatic renal cell carcinoma, preliminary INTUVAX-data now also shows a remarkable partial regression of all metastases in two patients who received add-on therapy with tyrosine kinase inhibitors after INTUVAX-treatment. These findings suggest that combination treatment with INTUVAX and certain tyrosine kinase inhibitors can have a synergistic antitumor effect.

Immunicum AB (publ), which develops therapeutic cancer vaccines, today announced continued compelling survival data from its phase I/II-study in metastatic renal cell carcinoma, showing a median survival for patients with poor prognosis (five patients) currently at 13 months compared to the expected median survival of 8-9 months for patients treated with tyrosine kinase inhibitors. One patient was excluded from the survival study since the patient in question in retrospect did not show any renal cell carcinoma metastases. Of the 11 remaining study patients with verified metastatic renal cancer, eight patients are still alive.

The Company also announced that two patients, whose tumor metastases after INTUVAX-therapy progressed, received add-on therapy with tyrosine kinase inhibitors and subsequently showed remarkable regression of all remaining metastases. In one case, a patient had four brain metastases of which two have gone into complete remission and the remaining two into a continued extensive partial regression. The second case involves a patient with extensive sarcomatoid tumor development, which also showed a partial regression of all metastases. According to the current established knowledge, neither of these two patients should have responded to treatment with tyrosine kinase inhibitors.

Immunicum has now submitted an application to the local ethical review board in Uppsala to collect additional data on tumor response from the recently completed phase I/II-study in metastatic renal cell carcinoma. The reason for the application is twofold. First, it seems that successful immunotherapy slows down tumor development and in some cases even induce a late regression of the tumors. Secondly, some of Immunicum's study patients have, due to tumor progression, received add-on therapy with tyrosine kinase inhibitors, which enables the Company to evaluate possible synergistic effects between INTUVAX-therapy and established treatments.

A scientific abstract with data from Immunicum's phase I/II-study in metastatic renal cell cancer will be presented at the world's largest cancer conference, the annual ASCO-meeting in Chicago, May 30 - June 3. The Company continues to collect data from the study and plans to announce overall information on the data collected until the time of the ASCO-conference, expected on June 2nd.

 

- Despite the restricted number of patients that makes it difficult to draw any firm conclusions, survival data so far looks very exciting. The remarkable tumor response we have seen in two of our patients who received add-on treatment with the approved drug Sutent may well be due to a synergistic effect with INTUVAX where Sutent "opened up" the tumor for vaccine-induced killer cells via a well-known "side effect " of Sutent, a down-regulation of the tumor tissue's immunosuppressive mechanisms, says Immunicum's Chief Scientific Officer, Alex Karlsson-Parra.

 

Immunicum is in the final stages of planning for a follow-up, and fully funded, phase II-study, which is expected to start in 2014.

Due to the information in this press release, Immunicum intends to prepare and publish a supplement to the prospectus prepared in connection with the invitation to subscribe for shares in the ongoing rights issue with preferential rights for existing shareholders. The prospectus supplement will be published as soon the Swedish Financial Supervisory Authority, Finansinspektionen, has given its approval.

 

For further information please contact:

Jamal El-Mosleh, CEO of Immunicum, +4631-41 50 53,
jamal.el-mosleh@immunicum.com

Redeye AB is chosen as the Company's Certified Adviser.

Tel: +468-545 013 31. www.redeye.se.

 

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. Since the raw material consists of allogeneic dendritic cells, Immunicum's products can be produced in large scale. The vaccines are now undergoing clinical trials in renal cell carcinoma and hepatocellular carcinoma.  

www.immunicum.com