Immunicum AB announces FDA clearance of its Investigational New Drug application for INTUVAX in metastatic renal cell carcinoma
GOTHENBURG, Sweden, December 13, 2016 - Immunicum AB (publ; First North Premier: IMMU.ST) a biopharmaceutical company developing sophisticated, safe and efficacious therapeutic cancer treatments, inducing powerful and long lasting immune responses, today announced that the United States Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug application (IND) for INTUVAX. The IND clearance enables Immunicum to expand its ongoing Phase II study - MERECA (MEtastatic REnal Cell CArcinoma) - for the treatment of metastatic renal cell cancer patients, into the United States.
"It is a very important milestone for Immunicum that the exchange of information with the FDA has resulted in the IND clearance. This allows us to move forward with the remaining steps required for the US sites to initiate patient recruitment," said Dr. Carlos de Sousa, CEO of Immunicum. "Our goal is to further substantiate the initial encouraging results we have seen in Europe in the phase I/II study, with clinical data from the US."
Dr. de Sousa added: "As previously announced, the MERECA recruitment process in Europe is ongoing and patients are actively being enrolled in selected European centers where Immunicum is conducting the Phase II MERECA study. We will provide a more comprehensive update of our global clinical development program for the MERECA study in the first quarter of 2017."
About renal cell cancer / carcinoma
Renal Cell Cancer (RCC) is a cancer that forms in the lining of very small tubes in the kidney that filter the blood and remove waste products. There are approximately 273,000 new cases of RCC diagnosed worldwide each year, representing approximately two percent of all cancers. The therapeutic effect of existing treatments, called directed therapies, is often of short duration, with limited survival rate gain. With no alternatives to these therapies, there exists a relatively large unsatisfied medical need for new treatments that are effective, more cost-efficient and have less unwanted side effects.
For more information, please contact
Carlos de Sousa, CEO, Immunicum
Ph: +46 (0) 31 41 50 52
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 a tumor-specific immune response.
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 additional clinical phase I/II studies in liver cancer and in
gastrointestinal stromal tumors (GIST). Immunicum is listed on Nasdaq First North Premier.
The company's Certified Adviser is Redeye AB
Ph: + 46 8 545 013 31
The information in this press release is disclosed pursuant to the EU Market Abuse Regulation. The information was released for public disclosure through the agency of the company's contact person on December 13, 2016 at 13.00 CET