Clinical Trials

Date: 2014-09-30

Type of information: Initiation of development program

phase: 3

Announcement: initiation of development program

Company: DanDrit Biotech (Denmark) DanDrit Biotech USA (USA - VT)

Product: MelCancerVac®

Action mechanism:

MelCancerVac® uses a patient’s own dendritic cells loaded with tumor antigens from the lysate of a specifically selected melanoma cell line. The melanoma cell line expresses a broad spectrum of cancer/testis antigens (in particular, the antigens of the MAGE family) and has low levels of expression of the melanocyte differentiation antigens. The original cell line used for the selection was isolated from a patient with a long-lasting disease-free period after the removal of a metastatic tumor. The melanoma cell line has been tested for safety and was found to be free of infectious agents. The melanoma cell lysate is combined with the patient’s own dendritic cells. The method of dendritic cell generation was initially optimized in order to increase the capacity of immature dendritic cells to load the exogenous antigens and present them for recognition by T lymphocytes. The method was also optimized to increase the efficiency of transformation of monocytes into dendritic cells and permits us to produce up to five portions of vaccine using only 200 mL of a patient’s blood.

In pre-clinical studies performed in vitro, dendritic cells loaded with melanoma cell lysate were able to stimulate the generation of cytotoxic T lymphocytes with broad anti-tumor specificity. This demonstrated that DanDrit’s dendritic cell system is capable of inducing an immune response against shared tumor-restricted antigens expressed in many types of solid tumors. The extent of tumor cell death was correlated with the number of expressed antigens of the MAGE family, the main group of the cancer/testis antigens. These data indicate that the lysate of our melanoma cell lines could be used for treatment of many kinds of solid tumors where cancer/testis antigens are expressed in significant amounts.

Disease: colorectal cancer

Therapeutic area: Cancer - Oncology

Country: Italy

Trial details:

Latest news:

* On September 30, 2014, DanDrit Biotech, the subsidiary of DanDrit Biotech USA, a biotechnology company seeking to develop an approved vaccine for the treatment of colorectal cancer, signed a contract of collaboration with the University Hospital IRCCS "San Martino" - IST – National Institute for Cancer Research known as the San Martino Hospital of Genoa. Dr. Alberto Sobrero, the Head of the Medical Oncology Unit at the San Martino Hospital is principal investigator of the randomized multicenter study. The collaboration relates to a Phase III adjuvant study of DanDrit's vaccine in patients with no evidence of disease stage IV colorectal cancer . The primary goal of the study is to evaluate the efficacy of DanDrit's MelCancerVac® ("MCV") in stage IV CRC patients rendered disease free after the completion of standard treatments in accordance with local practices.


Is general: Yes