Immunicum AB Announces Enrollment of First Patient in Phase I/II GIST Trial Following Study Protocol Amendment
GOTHENBURG, Sweden, March 7, 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 a new patient has been enrolled in the Phase I/II Gastrointestinal Stromal Tumor (GIST) study following the study protocol amendment, which was recently approved by the ethical committee and the Swedish Medical Products Agency. The study is conducted in collaboration with the Karolinska Institute and investigates the safety and efficacy of INTUVAX® in combination with tyrosine kinase inhibitors in patients with incurable GIST.
"GIST is a very rare and complex disease and we are very pleased that the optimization of the protocol to broaden the recruitment basis has achieved the first new patient enrolled," said Dr. Peter Suenaert, Chief Medical Officer of Immunicum. "Treatment options for GIST patients are limited and we believe that INTUVAX® can have a significant impact in this patient population. We look forward to continuing our collaboration with the Karolinska Institute and establishing clinical proof of safety and activity in this indication."
The open-label Phase I/II study conducted with the Karolinska Institute was initiated to evaluate the safety and efficacy of multiple intratumorally administered doses of INTUVAX® in patients with progressing GIST during ongoing treatment with a tyrosine kinase inhibitor. With the revised trial design to facilitate recruitment the trial is planned to enroll a total of 12 patients.
GIST is a tumor arising from Cajals interstitial cells in the gastrointestinal tract. GIST belongs to the group sarcoma cancer, cancers originating in the soft tissues. Every year about 200 new cases of GIST are diagnosed in Sweden.
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 March 7, 2017 at 8.00 am CET