News that Sanofi and Regeneron’s mAb alirocumab has lower cardiovascular risks than other cholesterol drugs may have grabbed recent headlines, but it is their asthma candidate, dupilumab, that has caught the eye of GlobalData analyst, Valentina Gburcik.
Gburcik, whose report on the global asthma market has just been published, told BioPharma-Reporter.com that: “Many major asthma players, including GSK, AstraZeneca, Teva and Roche, have targeted biologic therapies for asthma in late-stage development.
“In fact, these targeted therapies, which are mainly interleukin inhibitors, represent 90% of the entire late-stage asthma pipeline, which clearly shows the R&D trend in this space” she continued.
The discovery that asthma has multiple causes and subphenotypes prompted a change in drug development according to Gburcik, who said: “Advances in our understanding of the asthma pathogenesis have led to a major shift in potential treatment approaches.
“This realization is reflected in the current late-stage pipeline, which is dominated by biologics targeting various inflammatory pathways in specific patient subpopulations.”
She added that the dawn or personalised medicine, in which treatments are tailored to an individual’s genetic makeup, also had an impact on industry developments and further underlined the potential biopharmaceuticals have as asthma therapies.
“A personalized approach to asthma treatment also requires diagnostic tests to identify the responding patient pool before starting the treatment. Roche is currently ahead of the game in this respect, as it is an experienced player in developing companion diagnostic tests for its targeted therapies.
Gburcik predicted that: “Sanofi and Regeneron currently do not market any asthma medications, but have partnered to develop a promising targeted biologic therapy, dupilumab, which may earn the companies a significant position within the asthma space.
Dupilumab, which is also being trials as an eczema treatment, differs from other developmental asthma mAb because it targets two inflammatory interleukins – IL-4 and IL-13 – rather than the just IL-13 which is the focus of both Roche’s lebrikizumab and AstraZeneca’s tralokinumab.
The drug candidate was created using the Regeneron’s using VelocImmune mouse, which is a genetically modified strain in which genes encoding mouse immune system proteins have been replaced by their human equivalents.
As a result antibodies the mouse expresses are a mix of human variable regions and the constant mouse regions required for a robust immune response. This differs from other modification technologies in which the mouse regions are also replaced.
After an mAb has been identified, the next step is to replace the constant regions with human equivalents using standard modification techniques
Regeneron claims that the VelocImmune mouse strain is “a living factory that greatly increases the speed and efficiency for the generation of fully-human therapeutic antibodies.”