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HIV Pipeline
Monogram is constantly developing innovative technologies to help
our pharmaceutical and research collaborators create new HIV therapies.
These new technologies often result in commercial products used in patient
management. The following products are not yet available for patient management
purposes, but are available for use in drug development.
Click on the links below to learn more about our new technologies:
Entry Inhibitor Susceptibility
As a new drug class, entry inhibitors are a promising breakthrough that will offer
an effective treatment option to patients with a high level of treatment experience
and resistance to currently available drugs. The successful development of new drugs
in the entry inhibitor class requires unique drug resistance assay technology to
assess the susceptibility of HIV, particularly multi-drug resistant HIV, to these
new agents. Monogram engineered a phenotypic assay for use in clinical trials of
entry inhibitors (employed in the development of FUZEON), and now offers a
commercial version of this assay.
Why a separate assay for entry inhibitors?
Within the nucleoside, non-nucleoside, and protease inhibitor classes, each individual agent has a somewhat unique mechanism of action that often results in a distinct resistance profile. Fortunately, as new drugs become available in these classes, it is not necessary to develop new phenotypic technology beyond the assessment of susceptibility breakpoints (clinical cutoffs). However, entry inhibitors have extracellular mechanisms of action totally different from those of reverse transcriptase and protease inhibitors, demanding a new approach to the assessment of susceptibility. Extensive research into entry inhibitor development by Monogram and pharmaceutical companies yielded a phenotypic assay that can accurately measure activity of these new drugs against HIV.
Clinical studies utilizing the novel phenotypic assay revealed that HIV has a broad range of susceptibility to entry inhibitors — far greater than the natural range of susceptibility to any of the existing antiretroviral drugs. These findings indicate that treatment with these drugs may require a new approach to identify levels of susceptibility prior to the initiation of therapy.
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