The development process of new products at immatics is very fast compared to typical development cycles in the pharmaceutical industry. immatics can develop a product candidate – from the collection of the first tumor samples to the delivery of a multi-peptide drug into the clinic – within 24 months or less.
The Development process at immatics is focused, effective and fast:
Pharmaceutical Development (PD) & GMP Manufacturing. Once the relevant TUMAPs have been identified the next stage is to develop a stable and easy-to-handle formulation typically containing 8 to 12 different TUMAPs for administration in one single injection. Each individual TUMAP as well as the cocktail as a whole, has to be characterized physically, chemically, and microbiologically. Our chemists also develop manufacturing and analytical procedures that are subsequently used by the external GMP manufacturers.
Clinical Development. immatics maintains the operational and scientific expertise within the company. Core competencies are retained in our clinical development team. Much of the operation of clinical trials is outsourced to internationally operating, well-known CROs. Immunomonitoring, that is the ex vivo detection of activated T cells in vaccinated patients to determine immunological efficacy during clinical development, is maintained in-house.
Regulatory Affairs. Although our products are still in the early stages of development, we pride ourselves in the serious and comprehensive approach we take to the regulatory process. We find that the drug development process needs the continuous input of regulatory guidance at all stages with a focus on the manufacturing process and the clinical development strategy. We have substantial regulatory talent within our own management team and the supervisory board. We also maintain regular contact with regulatory authorities in order to improve our interaction with them.