Part II: Can Cancer be a Curable Disease in the Near Future?

Practical framework with which to consider clinical studies

As a framework to help us pull together both the diverse approaches being used, as
well as the counter-intuitive and sometimes disappointing findings from clinical
studies of cancer immunotherapy, a backdrop against which we could consider the
data to be presented was thoughtfully set forth by the first speaker and moderator of
the days session, Neil Berinstein (Aventis Pasteur). Important questions to be
considered were thus framed:

Is there a best platform to deliver antigens to the immune system for a therapeutic
cancer vaccine? A considerable number of strategies for active vaccination against
cancer have been developed, all of which have a sound theoretical basis. It is by no
means certain which, if any of these strategies will emerge as a leader.

What surrogate end-points can be used to judge vaccine efficacy? It is currently not
at all clear what assays can or should be used to document clinical end-points, indeed,
there are few data to support the validity of any in vitro assays as surrogate clinical
end-points. The ELISPOT assay has been shown to reliably detect the number of
antigen specific t cell production in experiments in which known quantities of antigen
specific T cells were added to PBMNC preparations. Computerized methods by which
to read the plates render this assay adaptable for monitoring large-scale clinical
studies. There is less clinical experience with other assays that may ultimately prove
to be of value, including tetramers and intracellular cytokine measurement. That there
may be a threshold value for any of these assays above which a correlation with
clinical activity can be seen is certainly possible, but this has not been reliably
demonstrated to date. The question of the optimal time at which to apply the relevant
assay has not yet been answered. In addition, peripheral blood has not been confirmed
as the tissue of choice upon which to look for tumor-specific T cell response.

What criteria should be used to decide when to move to large-scale clinical testing,
such as randomized phase III studies of efficacy? Should randomized, phase III
studies fail to demonstrate efficacy, the field will almost certainly have to develop
precise criteria for continuing such studies.

Should cancer vaccines be developed as mono or combination therapies? Both mono

and combination approaches have theoretical merit. Whilst cytotoxic chemotherapy
can certainly be considered as a prime, mediating DNA damage and resulting in
apoptosis of a cancer cell, following which a vaccine could provide a boost to
generate a cytotoxic T lymphocyte-mediated cytotoxicity, it is also likely that patients
being treated with conventional cytotoxic chemotherapies will be less likely to mount
an immune response.
Author Author

Creative Biolabs is a professional manufacturer of various antibody products as well

as related services, including chimeric antibody, muromonab, humanized antibody,
etc.

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