Cellin Technologies LLC ‒ a GMP cell therapy products manufacturing company located in Tallinn, Estonia ‒ this week started production of melanoma cell lysate, the critical raw material required for the manufacture of MelCancerVac, the colorectal cancer vaccine developed by DanDrit Biotech.
MelCancerVac is an immunotherapeutic treatment used in the treatment of colorectal cancer. It uses the patient´s own dendritic cells – critical components of the immune system – and loads them with tumor antigens from the lysate of a specifically selected melanoma cell line. The ability of the dendritic cells to induce a strong immune response is the basis of the vaccine therapies under development at DanDrit Biotech.
MelCancerVac has been tested in clinical trials for the treatment of two different types of cancer: colorectal cancer (CRC) and non-small-cell lung cancer (NSCLC). Phase I and phase II trials of CRC were carried out in Gentofte Hospital, Denmark and at the National Cancer Centre, Singapore. Phase II trials for NSCLC were conducted at Herlev Hospital, Denmark.
Phase IIb/III trials will be carried out using the vaccine manufactured by Cellin Technologies LLC this spring. If the trials are successful, MelCancerVac may become the world’s first vaccine against colorectal cancer.
This is the first time that Cellin Technologies LLC has produced personal vaccines for cancer patients. Cellin Technologies uses a state-of-the-art GMP cleanroom facility for the production of medicinal cell therapy products. They have extensive know-how and a competent quality management system, as well as a highly experienced and quality-driven team consisting of top medical and scientific specialists.
“DanDrit Biotech decided to manufacture MelCancerVac in Estonia for the reason that our laboratory complex, our technology, and the qualifications of our employees meet the highest standards. At the same time, the manufacturing costs are reasonable. About 12 months ago, we signed a contract to produce single components of MelCancerVac; today, we take care of the entire manufacturing process of the vaccine,” said Mart Raik CEO of Cellin Technologies.
Cellin Technologies has a contract to manufacture the vaccine to the end of 2017. They will produce the vaccine for 174 patients participating in Phase III of the clinical trials, and up to 500 patients taking part in a patient name use program. The manufacturing cycle for one vaccine is 8 days.
Cellin Technologies is a partner to the EU- funded Research and Development project, which studies how to the use of regenerative cells from human fat in the creation of new blood vessels. Their unique platform technology employs human adult mesenchymal stem cells from adipose tissue in order to produce cell products of the highest quality according to the EU regulations of Advanced Therapy Medicinal Products (ATMPs ).
Therapeutic dendritic cell-based vaccination of cancer patients represents one of the most promising non-toxic methods of cancer treatment. The main goal of the vaccination is to stimulate the patient’s own immune system to combat cancer cells. DanDrit uses the patient’s own dendritic cells, which are derived from monocytes in the blood and loaded with tumor antigens. The dendritic cells are then injected back into the cancer patient, where surface-expressed antigenic peptides are recognized by T lymphocytes. T lymphocytes are stimulated by the dendritic cells to proliferate and differentiate into effecter cells that specifically target and destroy tumor cells. DanDrit’s therapeutic cancer vaccine is used either as a separate treatment, or complementary to other types of treatment such as surgery, chemotherapy and radiotherapy.