Use of human blood products in testing therapeutic antibody fragments
Research type
Research Study
Full title
Use of human blood products in testing therapeutic antibody fragments
IRAS ID
180976
Contact name
James Legg
Contact email
Sponsor organisation
Crescendo Biologics
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, months, days
Research summary
Crescendo Biologics is a drug discovery company that develops therapeutic human antibody fragments, also known as Humabodies. As part of the drug discovery phase, antibody fragments undergo testing for a number of properties including the ability to modulate the biological properties of human immune cells. These properties are highly relevant to their use as therapeutics for cancers and other diseases where there is a significant need from patients for novel therapies that improve outcomes and increase quality of life.
For this project healthy donor blood samples are required. These samples will be sourced from external institutions who have obtained the relevant informed consent and that have anonymised the samples. Donors will not be identifiable and donor information does not form part of the data analysis for the project. Primary human blood cells will be purified from these samples and these cells used to identify Humabodies capable of binding to human cells and modulating their function in the desired way. Blood samples will also be used to characterise the biological mechanism of action of these humabodies, the proteins to which they bind and related molecules involved in disease processes. Typically, cells isolated from the blood samples will be incubated with antibody fragments and changes in a number of readouts including proliferation, cytokine release, cell surface marker expression, expression of downstream signalling molecules or cytotoxicity will then be measured. Genetic testing will not be performed on the donor samples. The data generated will support the progression of therapeutic agents through drug discovery and clinical testing in patients with unmet medical need and will contribute to the understanding of immunotherapy.REC name
HSC REC A
REC reference
15/NI/0110
Date of REC Opinion
4 Jun 2015
REC opinion
Favourable Opinion