Immunicum AB (publ) Announces Last Patient Last Visit in the Ongoing Phase I/II Hepatocellular Carcinoma Study

 

Press Release

15 August 2017

Immunicum AB (publ) Announces Last Patient Last Visit in the Ongoing Phase I/II Hepatocellular Carcinoma Study

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 the last patient last visit in the ongoing Phase I/II study of ilixadencel in hepatocellular carcinoma (HCC). The open label study enrolled eighteen patients and was conducted at the Sahlgrenska University Hospital at Gothenburg University. Topline results from the study following data analysis are anticipated before the end of the year. Ilixadencel, formerly known as INTUVAX, is a cancer immune primer developed for the treatment of solid tumors and is currently also being investigated in an ongoing Phase II trial in renal cell carcinoma (MERECA) as well as a Phase I/II study in gastrointestinal stromal tumors.

"Today's announcement continues the significant progress we have made within our clinical programs this year to demonstrate ilixadencel's therapeutic potential as an off-the-shelf immune primer in solid tumors. HCC in particular is a very severe type of cancer with limited treatment options and a strong demand for novel, innovative therapies such as ilixadencel," said Peter Suenaert, MD, PhD, Immunicum's Chief Medical Officer. "Especially in this rapidly advancing type of cancer, the ability to extend survival by even a few months is a positive benefit. The interim results we presented at the SITC Annual meeting last November were promising and we look forward to the complete results, which we hope to communicate before end of year."

The open-label phase I/II trial was initiated by Immunicum in 2013 to investigate safety and efficacy of ilixadencel, Immunicum's lead cancer immune primer, as second and first line therapy in HCC. Conducted at the Sahlgrenska University Hospital at Gothenburg University, the primary objective of the study is to investigate safety of the cell therapy product. Secondary objectives include immunological response and initial signs of efficacy on overall survival. In total, eighteen patients were enrolled in the study, seventeen with advanced HCC and one with bile-duct cancer (following protocol amendment). All patients were treated with at least one intratumoral dose of ilixadencel either as a monotherapy or in combination with first line treatment sorafenib. Interim results presented at the SITC Annual meeting in November 2016 demonstrated a good safety and tolerability profile.

More information on the study can be found on the clinicaltrial.gov page through the following link: https://www.clinicaltrials.gov/ct2/show/NCT01974661?term=Immunicum&rank=3

About hepatocellular carcinoma
Hepatocellular carcinoma (HCC) is one of the most common malignant tumors worldwide and the most common cause of death in people with liver cirrhosis. Progression is very rapid and prognosis is poor due to the inability to completely remove the tumor through surgery in most cases. Malignant transformation of liver cells may occur as a consequence of various origins, such as chronic viral hepatitis, alcohol, and metabolic disorders.

About ilixadencel

Ilixadencel cell therapy product (formerly known as INTUVAX®) is an off-the-shelf cancer immune primer, developed for the treatment of solid tumors. Its active ingredient is activated allogeneic 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.

For more information, please contact:

Carlos de Sousa, CEO, Immunicum
Telephone: +46 (0) 31 41 50 52
E-mail: info@immunicum.com

Investor Relations Sweden

Helena Stångberg
Hallvarsson & Halvarsson
Telephone: + 46 709 71 12 53
E-mail: helena.stangberg@halvarsson.se

Investor and Media Relations EU/US

MacDougall Biomedical Communications
Gretchen Schweitzer or Stephanie May
Telephone: +49 89 2424 3494 or +49 175 5711562
E-mail: gschweitzer@macbiocom.com or smay@macbiocom.com

The Company's Certified Adviser is Redeye AB
Telephone: +46 (0) 8 545 013 31
www.redeye.se

About Immunicum AB (publ)

Immunicum is establishing a unique immuno-oncology approach through the development of allogeneic, off-the-shelf cell-based therapies. Our goal is to improve survival outcomes and quality of life by priming the patient's own immune system to fight cancer. The company's lead product ilixadencel, consisting of pro-inflammatory allogeneic dendritic cells, has the potential to become a backbone component of modern cancer combination treatments in a variety of solid tumor indications. Founded and based in Sweden, Immunicum is publicly traded on the Nasdaq First North Premier. www.immunicum.com