GOTHENBURG, Sweden, November 14, 2016 - Immunicum AB (publ; First North Premier: IMMU.ST) , a biopharmaceutical company striving to develop sophisticated, safe and efficacious therapeutic cancer treatments inducing powerful and long lasting immune responses, today announced updated immunological and survival phase I/II data on hepatocellular carcinoma (HCC) patients treated with INTUVAX.
The results were presented in a poster session by Immunicum's Chief Scientific Officer, Alex Karlsson-Parra, on November 12 th , 2016 at the Society for Immunotherapy of Cancer (SITC) 31 st Annual Meeting, held in National Harbor, Maryland.
"The clinical data presented at the SITC annual meeting, in addition to our previous announcements about the trial, provide important information that we intend to use as a basis for developing INTUVAX to be an effective immuno-oncological treatment for a range of cancers. We have extended the study with six additional patients that received INTUVAX as first line systemic treatment in combination with standard treatments, which will allow us to better measure the impact of the approach", said Dr. Carlos de Sousa, CEO of Immunicum.
"Also, I can now announce that the last patient has been included in the study extension. In the upcoming Q1 report we will provide a general company update including clinical activities", he added.
The poster - titled "Intratumorally injected pro-inflammatory allogeneic dendritic cells as immune enhancers - a phase I/II study in patients with advanced hepatocellular carcinoma" - showed that 67% of fully treated patients with advanced HCC experienced increases in circulating tumor-specific CD8+ T cells.
Moreover, these increases appear to correlate with prolonged survival rates seen in the study as compared to historical median overall survival rates as documented in medical literature. In addition, these results support the achievement of the primary endpoint of the study since INTUVAX demonstrated a positive safety and tolerability profile with only two patients exhibiting treatment related serious adverse events (specifically fever which can be interpreted as a sign of systemic immune responsiveness towards the injected INTUVAX cells).
The full poster is available as a .pdf file on the Immunicum website under the following link: ( http://immunicum.se/pipeline/combig/clinical-...x-hcc-iii/ )
About the phase I/II study in HCC In late 2013, Immunicum initiated a clinical phase I/II study with its lead cancer immune primer, INTUVAX, as second line treatment in eleven patients with advanced hepatocellular carcinoma that had previously failed on first line standard treatments. Patients were treated with three intratumoral doses of INTUVAX as monotherapy with the primary objective to determine safety, and secondary objectives to determine immunological response and efficacy.
For more information, please contact Carlos de Sousa, CEO, Immunicum Ph: +46 (0) 31 41 50 52 E-mail: carlos.desousa@immunicum.com
About INTUVAX 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 (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 First North Premier. www.immunicum.com
The company's Certified Adviser is Redeye AB Ph: + 46 8 545 013 31 www.redeye.se
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 November 14, 2016 at 08.45 CET.
