10028428First in class to first in human: Harnessing physiological regulation mechanisms to enhance safety and efficacy of next generation bispecific antibodiesClosedCollaborative R&DInnovate UKTherapeutic antibodies are biological therapies that have revolutionised the way we treat cancer and inflammatory diseases. Novalgen, an emerging immunotherapy company, has developed a novel and smart type of antibody that stops exerting its therapeutic activity once they have completed their activity. In so doing, the NovalGen technology offers a new generation of antibody therapies with potential for maximal safety alongside maximal efficacy. Our first smart antibody therapy will treat Haemophilia A (HA), an inherited condition in which blood doesn't clot normally because it lacks sufficient blood-clotting proteins (clotting factors). Consequently, patients with haemophilia, experience spontaneous bleeds or bleed for a longer time after an injury than normal. Our new antibody drug will replace the missing clotting factor (FVIII) in patients with HA, but with the peculiarity that it will get inactivated once it has helped the formation of a blood clot, to avoid potentially life-threatening side effects associated with uncontrolled clotting. Before we test this new drug in people, we need to test it in the laboratory to establish that its safety and efficacy. This requires a comprehensive data package demonstrating that it is worth progressing this candidate drug to the clinic. The Biomedical Catalyst grant will enable NovalGen to develop very detailed data packages and prepare a clinical trial application which will be submitted to the UK regulatory agency (the Medicines and Healthcare Products Regulatory Agency \[MHRA\]) at the end of the project, to gain permission to administer this new drug to haemophilia patients, the first step in bringing a new drug to the market. Haemophilia products have a very good track record of obtaining approval if they clear the first hurdle of a Phase I clinical study, so funding from UKRI in support of this program could result in the UK being at the forefront of HA treatment in the future. Success with this drug will encourage NovalGen and other companies to make other "smart drugs" representing a step change in the way we treat diseases.