DCPrime BV, a clinical stage company developing dendritic cell vaccines to treat cancer, and apceth Biopharma GmbH, an established contract manufacturing organization in the field of gene and cell therapy, report today that they have entered into a strategic manufacturing agreement. The collaboration involves clinical batch production and the development of a commercial scale manufacturing process of cancer vaccines based on DCPrime’s technology platform DCOne®.
The companies also announce that apceth has recently successfully passed an inspection by the District Government of Upper Bavaria and the Paul-Ehrlich-Institute for the manufacturing license for production of DCP-001, DCPrime’s lead program. This will enable DCPrime to enter into a Phase II Proof of Concept study in Acute Myeloid Leukemia.
“Precisely because our platform allows, for the first time, production of dendritic cell vaccines in an off-the-shelf manner, and bypasses the costly and complicated manufacturing procedures of patient-derived dendritic cell vaccines, it is crucial for DCPrime to partner with apceth Biopharma, an experienced contract manufacturing company. This collaboration will be instrumental in bringing our innovative therapies to as many patients as possible”, says Dr Ada Kruisbeek, founder and CEO & CSO of DCPrime.
“We are pleased that our manufacturing relationship with DCPrime has started in such a successful manner and that after only one year, we can already ensure production of clinical batches and product supply to patients for further development of the first off-the-shelf dendritic cell vaccine to enter Phase II clinical studies”, says Dr Christine Guenther, apceth Biopharma’s CEO. “We at apceth are also very pleased that we will continue our relationship in the future, to enable large scale production and therefore product supply to even larger numbers of cancer patients”.
“It has been a pleasure working with the professional staff of apceth Biopharma during the early phases of technology transfer of our current production process, and we look forward to the next steps with respect to developing a commercial scale manufacturing process”, says Dr Sandra van Wetering, COO of DCPrime.