BETHESDA, Md., Jan. 27, 2014 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company
developing DCVax® personalized immune therapies for solid tumor
cancers, announced today that it has entered into a set of
agreements for large-scale expansion of the manufacturing, storage,
handling and distribution of its DCVax-L and DCVax-Direct products,
development of infrastructure and key systems, and execution of
product validation work required for any eventual regulatory
approvals, with the Company's long-time contract manufacturer,
Cognate Bioservices, Inc. ("Cognate").
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The agreements include a DCVax-L Manufacturing and Services
Agreement (the "DCVax-L Agreement"), a DCVax-Direct Manufacturing
And Services Agreement (the "DCVax-Direct Agreement"), an Ancillary
Services Agreement and a Manufacturing Expansion Services
Agreement, as well as a Lock-Up Agreement (collectively, the
"Cognate Agreements"). The Company previously announced plans
for these agreements, and the program and capacity expansions that
they will provide, in July, 2013, and during the remainder of
2013. The agreements were entered into on January 17, 2014.
In aggregate, these agreements provide for a comprehensive
scale-up program for expansion of the Company's clinical programs
in both the US and Europe, and for
any compassionate use programs or other early access or expanded
access programs which the Company might undertake. These
agreements also provide for an extensive development program to
carry out long-term preparations for eventual potential
commercialization (including building the infrastructure, systems
and logistics that will be needed), and to undertake the extensive
product validations that will be required for a product to be
considered for regulatory approval.
Cell therapy products, such as personalized immune cell
therapies for cancer, are especially challenging and complex.
The regulatory requirements for such products are far more rigorous
for Phase III clinical trials than for Phase II trials, and many
companies trying to develop cell therapy products have great
difficulty moving from Phase II to Phase III. Similarly, the
regulatory requirements for cell therapy products are even more
rigorous for commercialization than for Phase III trials. For
example, even for products that have met the rigor required to
proceed in Phase III trials, the further product validation work
required for such products to be considered for commercial approval
at the end of such Phase III trials requires well over a year of
extensive and intensive work. Similarly, the infrastructure
and systems for managing such cell therapy products for thousands
or tens of thousands of patients (or more) are extremely
demanding. To date, other companies have not successfully
scaled up to such levels on a practical basis. By entering
into this major development program now, the Company is getting an
important head start.
"We are excited to enter into a broad program to expand capacity
and build large scale infrastructure, systems and operations under
these Agreements with Cognate," commented Les Goldman, Senior VP of Business Development
at NW Bio. "Such a program is essential for our future
success, and involves a major commitment of resources and
time. Cognate is a world leader in such developments, with an
unparalleled 12-year track record of regulatory and operational
success with two dozen different cell product trials, and with
clinical grade manufacturing of cell products on 3 continents.
We could not have a better and more effective partner for
this major undertaking."
The Company believes that personalized immune cell therapies
offer exciting medical potential. In order for these
therapies to become practical and commercial successes, though, the
Company further believes that product development companies must
focus much more intensively and much sooner on the development of
adequate infrastructure, capacity, systems, logistics and product
validations. The Company has focused heavily on these areas
for many years. The new set of agreements with Cognate is
designed to take this progress substantially further.
For example, the Ancillary Services Agreement provides for a
broad range of services that will be needed on an expanded scale
for clinical programs, compassionate use and other early access or
expanded access programs, and eventual potential
commercialization. This Agreement includes long-term
cryopreservation and storage services; clinical and
commercial support services; supplier sourcing, validation
and monitoring; shipping, distribution and logistics;
scheduling system and other software design and development;
recordkeeping (which can be required for up to 30 years for
manufacturing and product information); product and process
validations services; a quality agreement for quality control
and quality assurance; and such other services as may be
necessary.
Such Ancillary Services will be essential for building and
operating the scale of infrastructure and systems needed for
eventual potential commercial operations and possible other
programs. The detailed interactions with each clinical
center, for each individual patient, for ongoing treatments over
years, as well as the manufacturing, storage, tracking, shipping,
logistics, distribution and follow-up of the individual DCVax®
products involved, already require substantial operations for Phase
III clinical trials. They will require operations on a vast
scale for commercialization, especially in multiple regions and
markets. The infrastructure and systems for such operations,
on a financially and operationally practical basis, with
personalized living cell products, do not yet exist in the
marketplace. They must be designed, created and built,
tested, validated and approved. In light of the Company's
clinical trials and other anticipated programs, the time to
undertake this is now. That is the focus of the Ancillary
Services Agreement.
The updated DCVax-L Agreement supersedes the prior agreement
entered into on April 1, 2011.
The DCVax-Direct Agreement establishes the arrangements for
contract manufacturing and related services (including ongoing
development work, regulatory support, quality control, etc.) Both
the DCVax-L program and the DCVax-Direct program are expected to
undergo large expansion during 2014. The Manufacturing
Expansion Services Agreement covers activities related to the
development of more manufacturing infrastructure worldwide.
The provisions of all the Cognate Agreements can be found in the
Company's Form 8-K filed on January 24,
2014.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on
developing immunotherapy products to treat cancers more effectively
than current treatments, without toxicities of the kind associated
with chemotherapies, and on a cost-effective basis, in both
the United States and
Europe. The Company has a broad platform technology for DCVax
dendritic cell-based vaccines. The Company's lead program is
a 312-patient Phase III trial in newly diagnosed Glioblastoma
multiforme (GBM). GBM is the most aggressive and lethal form
of brain cancer. The Company is also under way with a
60-patient Phase I/II trial with DCVax-Direct for all inoperable
solid tumors cancers, with a primary efficacy endpoint of tumor
regression. The Company also previously received clearance
from the FDA for a 612-patient Phase III trial in prostate
cancer. The Company also conducted a Phase I/II trial with
DCVax for metastatic ovarian cancer together with the University of
Pennsylvania.
Disclaimer
Statements made in this news release that are not historical
facts, including statements concerning future treatment of patients
using DCVax and future clinical trials, are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as "expect," "believe,"
"intend," "design," "plan," "continue," "may," "will,"
"anticipate," and similar expressions are intended to identify
forward-looking statements. Actual results may differ
materially from those projected in any forward-looking
statement. Specifically, there are a number of important
factors that could cause actual results to differ materially from
those anticipated, such as risks related to the Company's and
Cognate's abilities to carry out the intended expansions
contemplated in the Cognate Agreements, risks related to the
Company's ability to enroll patients in its clinical trials and
complete the trials on a timely basis, the uncertainty of the
clinical trials process, uncertainties about the timely performance
of third parties, and whether the Company's products will
demonstrate safety and efficacy, and risks related to the Company's
ability to raise additional capital. Additional information
on these and other factors, including Risk Factors, which could
affect the Company's results, is included in its Securities and
Exchange Commission ("SEC") filings. Finally, there may be
other factors not mentioned above or included in the Company's SEC
filings that may cause actual results to differ materially from
those projected in any forward-looking statement. You should
not place undue reliance on any forward-looking statements.
The Company assumes no obligation to update any forward-looking
statements as a result of new information, future events or
developments, except as required by securities laws.
SOURCE Northwest Biotherapeutics