Introduction:
Is high-risk development of therapeutic cancer vaccines a
good opportunity for pharmaceutical companies? In 2009, excitement built around
several late-stage cancer vaccines that represent a new means to treat or
prevent certain cancers. Efficacy has been disappointing for many vaccines,
however, and the development of these vaccines is a high-risk endeavor. This
risk is balanced by the prospective benefit of a new category of potential blockbusters
that can help inhibit the progression of existing cancers, prevent recurrence
of cancers, or destroy residual cancer cells not killed by prior treatments.
Large and small pharmaceutical and biotech companies all look to one another as
sources for needed licensing, partnering, and acquisition activities. To
understand the landscape and dynamics of the cancer vaccine industry, we looked
at different types of companies that are active in cancer vaccine development,
analyzed their drug development and commercialization activities, and explored
potential opportunities.
Questions Answered in This Report:
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Cancer vaccine development is high risk with high potential
benefits.
Is the high-risk development of therapeutic cancer vaccines a good
opportunity for pharmaceutical companies? What will a cancer vaccines
market look like?
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Cancer vaccines represent a new paradigm in the treatment of
cancer.
What do surveyed oncologists and urologists think about the
prospects of cancer vaccines? What are their views on patient-specific versus
off-the-shelf vaccines?
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Who are the major players and potential dealmakers in the
cancer vaccine arena?
Which smaller companies have cancer vaccines in
development? Which Big Pharma and Midsize Pharma companies are already active
in cancer vaccines and with which partners? Not all pharmaceutical companies
are equipped to enter the cancer vaccine arena or to partner with a cancer
vaccine company—why? What new financing vehicle was launched in 2009?
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The availability of appropriate regulatory guidelines has
hindered cancer vaccine development and approval.
What did the FDA recommend
in its recent guidance document? What cancer vaccines are in
late-stage development?Scope:
Cancer vaccines: therapeutic vaccines, prophylactic
vaccines, vaccine technologies, immunomodulators, virally induced cancers,
autologous vaccines, off-the-shelf vaccines, patient-specific vaccines, active cellular
immunotherapy, peptide vaccines, anti-idiotype vaccines, antibody-targeted
vaccines, fusion proteins, dendritic-cell-based vaccines, cancer stem cells,
immune tolerance, immunosuppression, adjuvants.
Dealmaking and financing: 15 cancer vaccine companies,
partnering deals, mergers and acquisitions, financing, Cancer Immunotherapy
Index Fund, shelf registration, Chapter 11 bankruptcy, first negotiation
rights, potential Big Pharma and Midsize Pharma partners.
Clinical development: good news and bad news in 2009,
manufacturing considerations, findings presented at the American Society of
Clinical Oncology meeting in 2009, primary end points, combination therapies,
Phase III vaccine pipeline, overall response rate (ORR), progression-free
survival (PFS), overall survival (OS), time to disease progression (TTP).
Regulatory approval: draft guidance, 13 FDA recommendations, fast-track
status, codevelopment pathway, associated diagnostic tests, special protocol
assessment, conventional cancer trials, proof-of-concept studies, 3+3 drug
escalation approach, accelerated titration approach, single-arm trials,
randomized trials, superiority trials, equivalence/noninferiority trials,
accelerated approval regulations.
Primary data: Decision Resources’ Pharmaview and
Onkos analyst insights; May 2009 survey on advanced cancer vaccines: 70
oncologists, 71 urologists, and 20 managed care organization pharmacy directors
(MCO PDs); insights on Celldex Therapeutics/Pfizer’s CDX-110, biomarkers,
reimbursement, diagnostic tests, Dendreon’s Provenge.
Outlook: emerging market characteristics, likely
blockbuster, convergence, a prudent caution.