June 1, 2015
The field of immuno-oncology seems to be the hottest topic in biotech.
Following the approval of Rituximab, the first antibody to treat cancer in
1997, the field has been growing in momentum. The first cellular cancer
vaccine, Sipuleucel-T, was recently approved (2010), and more novel and
innovative ideas are being explored every day, including how to reprogram
an immune system to target cancer. The field is dynamic and changing,
exploring therapeutic vaccines and modified t-cell therapies, as well as
learning to target HLA ligands and t-cell epitopes specific to the patient and
the tumor. CTI has had the unique opportunity to be part of this exciting and
dynamic evolution over the past two decades.
Several immono-oncology therapies have recently been approved or will be
approved in the very near future by regulatory authorities around the world.
These include agents against melanoma, lung, colorectal, renal and prostate
cancers. Each of these programs have unique challenges, including defining
pre-clinical models, negotiating regulatory pathways into the clinic and to
approval, managing complex patient populations in clinical trials, organizing
a comprehensive manufacturing and supply depot approach to the
investigational product, and assessing a pricing and reimbursement strategy
that can be defended to payers, healthcare providers and patients. CTI can
assist in all of the above assessments. From our global regulatory affairs
department, who interacts frequently with authorities, to our
experienced clinical operations team, who can expedite enrollment and
ensure quality data to support approval, to our health economics
outcomes research group, who performs analysis to develop optimal
pricing and reimbursement strategies - CTI has played an integral role in
many of the leading programs currently in development today.
Immuno-oncology is the frontier of personalize medicine, and it is an area
CTI excells in. Approximately 30% of CTI's most recent programs are in
oncology and cell therapy, and over half of our recent projects are
deeply rooted in immunological indications. Our approach has stayed true
to our therapeutic focus and clinical trial expertise. We focus in complex
and critically ill patient populations, bringing a huge reservoir of
immunology and cellular therapy expertise to these programs.
For more information, contact us.