12 June 2017
Immunicum AB receives the approval of the international non-proprietary name (INN) ilixadencel for INTUVAX®
–One of the first names on the cell-based therapies that have been established by the WHO–
Immunicum AB (publ), First North Premier: (IMMU.ST), a biotechnology company that develops new immunaktiverande cancer treatments for a number of solid tumors, announced today that the company has received the approval of the international non-proprietary name (INN), ilixadencel for its leading drug candidate INTUVAX®, a cancerimmunaktiverare specially developed to enhance the patient’s own immune system by recognizing and attacking cancer cells. INN-the system has been established to facilitate the identification of pharmaceutical substances or active pharmaceutical components in a unique and universal way. Ilixadencel is the recommended generic name the world health organization (WHO) has selected, in close cooperation with the “Expert Advisory Panel” at The “The International Pharmacopoeia and Pharmaceutical Preparations”.
“The approval of the INTUVAXs private INN, is one of the very first names of cell-based therapies that have been established by the WHO, and partly to be seen as a recognition of our product’s unique characteristics. This means that we can be consistent, especially as we work with clinics all over the world as part of our global development programme for ilixadencel. We are excited to have received our application on the INN accepted and approved by WHO. From now on we will use the nomenclature ilixadencel in all communication regarding this cell therapy,” says Carlos De Sousa, CEO of Immunicum.
Ilixadencel is a storable allogeneic cell-based immunotherapy that is currently being evaluated in a global phase 2 study of renal cancer patients, MERECA (MEtastatic REnal Cell CArcinoma). The study examines and documents the effect of ilixadencel and is currently underway in eight countries in the EU, and has been approved by the FDA for start in the united states. Ilixadencel is also included in the ongoing phase 1 studies to evaluate its potential as a treatment for liver cancer and gastrointestinal stromal tumors (GIST).
Ilixadencel, cell therapy medicinal products (previously known as INTUVAX) is a cancerimmunaktiverare developed for the treatment of solid tumors. Its active ingredient, pro-inflammatory allogeneic dendritic cells, is formulated from healthy blood donors. Intratumoral injection of these cells is expected to lead to an inflammatory reaction, which in turn leads to tumor-specific activation of the patient’s cytotoxic T-lymphocytes.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Carlos de Sousa, CEO, Immunicum
Telephone: +46 (0) 31 41 50 52
INVESTOR RELATIONS, SWEDEN
Hallvarsson & Halvarsson
Telephone: + 46 709 71 12 53
MacDougall Biomedical Communications
Gretchen Schweitzer or Stephane May
Telephone: +49 89 2424 3494 or +49 175 5711562
E-mail: firstname.lastname@example.org or email@example.com
The company’s Certified Adviser is Redeye AB
Telephone: +46 (0) 8 545 013 31