NW Bio Enters Into Agreements For Large-Scale Expansion Of Product Manufacturing, Handling And Distribution
Expansion for Clinical and Other Programs; Long-Term Preparations for Eventual Commercialization
BETHESDA, Md., January 27, 2014 – 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”).
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.
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.