Excerpted from our Biotechnology report 2016 — Beyond borders: Returning to Earth
Guest perspective
John Orloff
Stefan Krauss
Global Head of R&D
and Chief Scientific Officer
Senior Director, Business
Development and Licensing
Baxalta
Baxalta
Winning in
immuno-oncology:
it takes a portfolio
Immuno-oncology (IO) has changed the game for
cancer drug developers. Chasing single-agent cancer
blockbusters has been overtaken by clinical exploration
of a rapidly evolving kaleidoscope of combinations
involving novel cancer immunotherapies. To win in IO,
one must use good judgment to balance risks across
multiple dimensions.
Of course, building new strategies and assets in a rapidly
evolving area like IO begins from the foundation of a company’s
existing capabilities. Strong competency in IO requires worldclass clinical, regulatory and commercial experience to identify
potentially first-in-class IO combinations and the right trials.
This is particularly important given the novelty of IO therapies,
where there is a very limited foundation of clinical data to
build upon.
Immuno-oncology has become a key focus area in oncology
drug discovery and development. The complexity of this
promising field makes it different in many ways from traditional
drug development. IO treatments span many modalities, from
cell therapies to antibodies to small molecules. The science
is evolving rapidly, and it is difficult to predict which products
will ultimately be best-in-class. Furthermore, it has become
apparent that achieving optimal treatment efficacy often
requires combinations of drugs that engage the immune system
across multiple mechanisms.
At Baxalta, we have continually emphasized external innovation.
Our size — not too large and not too small — is an asset, allowing
us to be nimble as we create IO partnerships. And recently, we
have been able to expand our IO capabilities thanks to two new
alliances: one with Symphogen, announced in January, to gain
access to checkpoint inhibitors and modulators, and another
with Precision Biosciences, signed in February, which expands
our capabilities in gene editing for CAR-T cell therapies. At the
same time, Baxalta’s longstanding capabilities in the complex
fields of hematology and immunology, along with our more
newly established oncology franchise, have critically informed
how we understand and approach IO.
To create these new IO combinations, companies must go
“beyond borders” and bridge barriers between drug classes,
technologies and companies.
Building a portfolio of IO assets through strong external
relationships and partnering
How does a company assemble the right capabilities to compete
in such a rapidly evolving field? A key part of the equation is
business development. Collaboration to gain access to early
innovation has long been a mainstay for pharmaceutical
companies. Ideally, these alliances include many different
kinds of players: big companies, smaller biotechs and
academic partners.
An IO strategy to “cut a wide swath”: broad capabilities
and capital efficiency
Via partnerships, we have implemented a risk-balanced, capitalefficient IO strategy that integrates a range of capabilities. Our
IO investments span three major domains, each representing a
different level of risk:
• Lower Risk: Established IO areas with approved products and
derisked asset classes
• Medium Risk: Fast-follower areas where preliminary proof of
concept or emerging clinical data exist
• Higher Risk: Novel therapies where it may be possible to be a
leader in first-in-class assets
Prior to investing, we map a portfolio of IO modalities and
technologies based on their scientific risk profiles and
competitive intensity (see accompanying figure). Products in
more developed areas may have lower scientific risk but cost
more to license because there is obviously greater demand for
products with proof-of-concept data.
Evaluating IO modalities and technologies via such a framework
can help a company identify the ones that best fit within its
portfolio. Certainly, this strategy has helped Baxalta articulate
its “sweet spot” and maintain its strategic focus.
Such single-mindedness is essential given the fierce competition
for assets and the breadth of indications that might be treated
by these medicines.
In order to implement our strategy while maintaining capital
efficiency, we have embraced a range of deal structures,
including option-based deals. These deal structures are a
cost-efficient way for us to expand our R&D portfolio and
are attractive to biotech partners that want to retain their
autonomy while leveraging the development, regulatory and
commercialization expertise of a bigger biopharma partner with
global presence and reach.
Winning IO strategies have advantages far beyond a company’s
oncology business. These strategies can be synergistic with
other therapeutic areas in a company. For example, the new IO
capabilities we have built through our R&D partnerships with
Symphogen and Precision BioSciences build on our own internal
competencies in immunology, gene therapy and cell therapy,
as well as oncology. Also, the new technical skills needed in IO,
such as gene editing, can be applied in other disease areas.
Our goal is to create efficacious, patient-focused medicines that
are truly differentiated. No matter the disease area, therapeutic
complexity is only increasing. Going forward, the successful
companies will be the ones that systematically and resolutely
create a risk-adjusted portfolio, leveraging partnerships
and collaborations to share access to the best assets and
technologies and accelerate innovation.
IO Modalities and technologies: risk mapping
Source: Baxalta
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