DogBiTE – a platform for validation of immunotherapeutic drugs

The current challenge in immunotherapy development is that preclinical models often fail to accurately predict human responses, leading to high failure rates in clinical trials and delaying the availability of effective cancer treatments. This issue is particularly pronounced in targeted therapies for solid tumors, such as osteosarcoma, where reliable models are critically needed to improve outcomes. The DogBiTE development addresses this gap by developing a comparative oncology model that leverages canine immune systems that more closely mimic human cancer biology. This positions the DogBiTE platform as a highly predictive and commercially attractive asset for both human and veterinary pharmaceutical partners, accelerating the development of Bispecific T-cell Engager (BiTE) therapies. Our lead drug candidate is the first BiTE designed for both humans and dogs. The QUAL grant was crucial in validating the DogBiTE platform, securing early and broader IP protection and gathering valuable feedback from industry and regulatory bodies.

The DogBiTE platform can have positive societal and environmental impacts by addressing UN Sustainability goal 3 and 9. The DogBiTE platform provides an opportunity to study spontaneous cancers (like osteosarcoma) in canine models, rather than using mouse models, benefiting both dogs and, hopefully by translation, humans. This holds the potential to improve the health and well-being of animals and humans. The DogBiTE platform can also contribute to a more efficient drug development for the pharmaceutical industry by 1) accelerating the translation of the most promising pre-clinical discoveries into the human clinic, and 2) doing pre-clinical efficacy assessment of drugs in dogs and thereby reduce the risk of failures and reduce the costs of developing new drugs for human medicine.