Immunicum AB announces approval in France for its Clinical Trial Application for INTUVAX in metastatic renal cell carcinoma
GOTHENBURG, Sweden, February 14, 2017 - Immunicum AB (publ; First North Premier: IMMU.ST), a biopharmaceutical company advancing a novel immuno-oncology treatment against a range of solid tumors, today announced that the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) in France has approved the Company's Clinical Trial Application (CTA) for INTUVAX. The CTA approval enables Immunicum to include patients in France in its ongoing Phase II study - MERECA (MEtastatic REnal Cell CArcinoma) - for the treatment of metastatic renal cell cancer.
"This approval from the ANSM allows us to move forward with recruitment of patients in France, a large and important location for the MERECA trial," said Dr. Carlos de Sousa, CEO of Immunicum. "It also represents the last outstanding EU country for which we were awaiting CTA approval."
About renal cell cancer / carcinoma
There are approximately 273,000 new cases of Renal Cell Cancer (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.
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 tumor-specific activation of the patient's cytotoxic T-lymphocytes.
About Immunicum AB (publ)
Immunicum AB (First North Premier: IMMU.ST) is a clinical stage company developing novel immuno-oncology therapies against a range of solid tumors. The Company's lead compound, INTUVAX® is currently being evaluated in clinical trials for the treatment of kidney cancer, liver cancer and gastrointestinal stromal tumors. INTUVAX® was designed to combine the best of two worlds: a cost-effective cell-based (allogeneic) and off-the-shelf therapy that is capable of triggering a highly personalized and potentially long-lasting immune response against tumor cells throughout the body. www.immunicum.com
For more information, please contact
Carlos de Sousa, CEO, Immunicum
Ph: +46 (0) 31 41 50 52
MacDougall Biomedical Communications
Gretchen Schweitzer or Stephanie May
Ph: +49 89 2424 3494 or + 49 175 571 1562
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 February 14, 2017 at 17:40 CET