apceth is a rapidly growing, clinical stage biopharmaceutical company, based in Munich, developing first-in-man, first-in-class, targeted therapies for cancer, inflammation and tissue regeneration.
Our proprietary platform technology is based on next generation cell-based therapeutics, which offer significant advantages over existing technologies.
apceth is actively developing next generation genetically modified MSC therapeutics for the treatment of cancer and rare diseases. The company’s first engineered cell product is Agenmestencel. A clinical trial for the treatment of cancer is ongoing and is the world’s first clinical trial with genetically-modified MSCs.
Agenmestencel-T is apceth’s first-in-man, first-in-class, next generation cell therapy product of genetically-modified mesenchymal stem cells for the targeted treatment of advanced cancer. The cells are purified from the patient’s bone marrow, multiplied in cell culture and genetically modified using apceth´s proprietary technology. A phase I/II clinical trial for the treatment of advanced gastrointestinal tract
adenocarcinoma, investigating the tolerability and safety of Agenmestencel-T, has already entered the Phase II stage in 2015.
Agenmestencel-L is the off-the-shelf version of Agemnestencel-T, produced from the bone marrow of healthy donors and is currently in late-stage preclinical testing and due to enter clinical trials shortly for the same indications.
Contract GMP Manufacturing
apceth also offers its state-of-the-art production and quality management system for contract GMP manufacturing, process development and associated GMP services, regulatory and logistical support for cell based products.
Independently of the type of cell therapy product or the respective indication, the production of cell-based therapeutics is highly complex. apceth has therefore established a robust state-of-the-art production process for cell products, fully compliant with all current European ATMP regulations and general FDA requirements. apceth was one of the first companies in Germany to receive a manufacturing license in 2010 for pharmaceutical production of cell therapeutics.
We are able to manufacture any cell type, native or gene modified, according to your needs, to the highest standards of quality and adherence to local laws and regulations in Europe and other international regulatory territories. We are also able to develop GMP processes.