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.
DCPrime’s is a privately owned, clinical stage biotechnology company focused on developing therapeutic, dendritic cell-based cancer vaccines. DCPrime’s technology platform is based on the DCOne® cell line, which is derived from myeloid leukemia cells and expresses a number of validated tumor antigens. This makes the platform suitable for application in patients with myeloid and other hematological cancers. In addition, DCOne® cells can be loaded with tumor associated antigens of choice, to develop cancer-specific vaccine formulations for multiple other (solid) cancer types. The company’s lead product DCP-001 is positioned as a consolidation vaccine therapy in Acute Myeloid Leukemia (AML). A Phase I/IIa study with this product has been completed and shows that DCP-001 is a safe product that induces a clear anti-tumor response in patients, and strong survival improvement in several of the studied patients. DCPrime received orphan drug designation in AML for this product from the EMA and is currently preparing a multi-center Phase II trial to demonstrate efficacy in AML patients.
About apceth Biopharma GmbH
apceth Biopharma is a leading company in cell-based gene therapeutics with an innovative portfolio of drug candidates for the treatment of chronic inflammation, autoimmunity (immunomodulation) and solid cancer (immuno-oncology). Through introduction of different therapeutic transgenes into MSCs, apceth is developing two potent next generation MSC-based gene therapy products. apceth-201 expresses the immunomodulatory protein Alpha-1 Antitrypsin for the treatment of Graft-vs-Host-Disease. The company’s second program, apceth-301, expresses a potent immuno-stimulatory “cocktail” of cytokines which locally activates the immune system to eradicate tumor cells. apceth-301 is currently being developed for Glioblastoma.
apceth is also an experienced and certified Contract Development & Manufacturing Organization for Advanced Therapy Medicinal Products (ATMPs) with a high international reputation for professionalism, quality and reliability. The company has state-of-the-art manufacturing facilities (ISO5, ISO7, ISO8, BSL2 cleanrooms), is certified for GMP production, and has an extensive quality management system, allowing apceth to ensure full regulatory compliance as well as the utmost GMP and quality standards according to regulatory requirements for ATMPs. apceth has successfully obtained multiple manufacturing licenses for different types of native and genetically engineered cells and cell-based products. apceth was the first company worldwide to obtain approval for the clinical testing of genetically engineered MSCs in patients. Irrespectively of the type of cells and cell products (native or genetically engineered HSC, MSC, and immune cells), or the cell source, apceth provides fully customized solutions in the development and production of every customer product and process. Located centrally in the heart of Europe, apceth can perform efficient and fast supply of the client’s products across the continent.
Dr Christine Guenther, CEO
+49 (0)89 7009608 0
Dr Ada M. Kruisbeek
2333 BD Leiden
+ 31 (0)6-551 72 158