Gothenburg, Sweden, May 17, 2016 - Immunicum AB (publ), pursuing to develop sophisticated, safe and efficient therapeutic cancer treatments with powerful and long lasting immune responses, today announced the establishment of a clinical development services agreement with Accelovance to advance the Company's lead cancer immune primer, INTUVAX, into the US in kidney cancer and in melanoma. Through this agreement, Accelovance, a Contract Research Organization (CRO), will support Immunicum's clinical development strategies by offering scientific, medical and regulatory expertise, in addition to providing support through Project Management, Clinical Monitoring, Data Management, Biostatistics, and Safety services for Immunicum's clinical trials in the US. The agreement will also provide access to Accelovance's Preferred Sites Network via their association with the US Based non-profit, Midwest Melanoma Partnership (MMP). Lead Investigator in the US, Dr. Arkadiusz Dudek, Director of the Oncology Clinical Trials Office at the University of Illinois' College of Medicine, has many years of experience in immuno-oncology and has previously conducted clinical trials in kidney cancer and melanoma.
"This partnership will bring together an extraordinary team and ample resources to advance and expedite the development of INTUVAX and Immunicum's clinical advancement in the United States", said Jamal El-Mosleh, CEO of Immunicum. El-Mosleh continued, "We believe we have found the best collaboration scenario to aid us with our company's next step in clinical development. This new agreement underscores our commitment to researching the effectiveness of INTUVAX as a cancer immune primer in additional indications and expands our research capabilities tremendously. We are very excited to have Dr. Dudek as our Lead Investigator for the MERECA-trial in the US and for the melanoma trial in the US. His expertise in heading up laboratory research on cancer microenvironment, angiogenesis, cancer vaccines and preclinical novel drug testing, along with the solid experience of Accelovance and the MMP, makes moving forward possible".
Under the agreement, Immunicum will maintain oversight and quality standards relating to patient safety and regulatory compliance, with Accelovance assisting with the development and implementation of clinical strategies. Immunicum will rely on Accelovance's knowledge in the areas of vaccines, oncology, and clinical management. Providing advanced insight into Immunicum's development pipeline will enable both organizations to enhance operational planning, consistency, and execution.
Arkadiusz Dudek, MD, Director of the Oncology Clinical Trials Office at the University of Illinois' College of Medicine, will be the Lead Investigator on both the MERECA (MEtastatic REnal cell CArcinoma) Trial and the US Melanoma Trial, slated to begin later this year. Dr. Dudek's clinical interests include phase I and II clinical trials in solid tumors; pancreatic cancer, malignant melanoma, kidney cancer, and thoracic malignancies, and high dose interleukin-2 program.
"We are extremely excited to enter into this partnership with Immunicum. INTUVAX has stimulated significant interest with Accelovance as well as with the Lead Investigator, Arkadiusz Dudek, MD. Combined with our strategic experience and our alliance with the Midwest Melanoma Partnership, we will be able to further enhance the research and advancement of treatment options for cancer patients. It is a win-win for everyone," said Accelovance's Chief Science Officer, Jamie Oliver, Pharm.D.
For further information, please contact:
Jamal El-Mosleh, CEO, Immunicum
Phone: +46 (0) 31 41 50 52
jamal.el-mosleh@immunicum.com
The Company's Certified Adviser is Redeye AB
Phone: +46 (0) 8 545 013 31. www.redeye.se
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 Accelovance
Accelovance, Inc., headquartered in Rockville, MD, is an industry award-winning global Contract Research Organization (CRO) focused primarily in vaccine, oncology, and general medicine clinical research. As a clinical services provider to the pharmaceutical and biotechnology industries, Accelovance offers comprehensive clinical development services including management and implementation of Phase I-IV clinical trials, supportive research centers, and a clinical engagement solution utilized for recruitment, post-marketing surveillance, and long-term survival follow-up.
For more information, please visit www.accelovance.com
About the Midwest Melanoma Partnership (MMP)
The Midwest Melanoma Partnership (MMP) is a Multi-Institutional collaboration of physicians, scientists and patient advocates dedicated to the development of improved therapies for patients with malignant melanoma. Composed of 19 member organizations well known within the academic and community research field (http://www.midwestmelanoma.org/?page_id=39), member organizations work within their institution and across MMP membership institutions to participate in clinical trials to advance treatment options for patients diagnosed with melanoma.
For more information, please visit www.midwestmelanoma.org.
About Immunicum AB (publ)
Immunicum AB (publ) is working to develop and advance cancer immune primers for the treatment of tumor diseases. A clinical phase II 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).
For more information, please visit www.immunicum.com