Complementary to Technology & IP Already Owned or In-Licensed;
Significant Step in Building a Leading Dendritic Cell Franchise

BETHESDA, Md., June 17, 2024 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax^® personalized immune therapies for solid tumor cancers, announced today that on June 12, 2024 it entered into an exclusive license from Roswell Park Comprehensive Cancer Center for a portfolio of dendritic cell technologies and intellectual property (IP).  The technologies are already in Phase 2 clinical trials, and the Company plans to collaborate with the lead scientist-clinician, Dr. Pawel Kalinski, on the further development of the technologies.  The license is the culmination of more than 2 years of discussions and negotiations.

The license includes 5 new patent families that were just filed in 2023 and hence have their full potential patent life ahead of them.  The technologies include enhanced versions of dendritic cells (DCs) and DC based therapies, as well as conditioning regimens designed to enhance patient responses and approaches to reprogram the tumor microenvironment to boost immune therapies and help overcome resistance to checkpoint inhibitors.

The DC based therapies include versions with tumor antigens loaded into the DCs and versions for intra-tumoral administration without pre-loading of antigens.  Phase 2 trials involving the licensed technologies for two different cancers opened for enrollment earlier this year and are currently under way, and a third Phase 2 trial for a third cancer is pending.  The trials are fully funded by grant funding and are being conducted as investigator led trials.  The Company does not anticipate having to provide any funding or undertake any operational role for these trials.

As previously reported, over time the Company has been quietly in-licensing various technologies and IP from various institutions and entities which it believes can be valuable in building a leading franchise in dendritic cell therapies. 

The portfolio in-licensed from Roswell Park is complementary to, and builds upon, a portfolio which the Company exclusively licensed from another institution last year.  Together, the two portfolios encompass more than 20 years of work by one of the foremost groups of dendritic cell experts, led by Dr. Kalinski.

The portfolio in-licensed last year includes the foundational technologies and IP, and positive early-stage clinical trial results, developed by the Kalinski group over 17 years before coming to Roswell.  The portfolio in-licensed now includes the further work during the last 7 years at Roswell.  Taken together, the Company believes that the two portfolios comprise a whole that is greater than the sum of its parts and offer compelling synergies with the Company's own portfolio.  The Company plans to collaborate with Dr. Kalinski on the further clinical development of the combined technologies.

The Company believes that the infrastructure and systems it has developed, and experience it has gained, in producing and delivering personalized living-cell DC based therapies for large numbers of patients make it uniquely positioned to help accelerate the late-stage development of the licensed DC technologies.  The Company's 331-patient Phase 3 clinical trial remains one of the largest personalized cell therapy trials conducted to date, and the Company's extensive experience treating compassionate use patients has added valuable ongoing "real world" experience. 

"We are excited to join forces with Dr. Kalinski, one of the foremost experts on dendritic cell biology and therapies," commented Linda Powers, the Company's CEO.  "We also greatly appreciate the supportiveness of the institutions throughout the long process of working out the arrangements to keep the Kalinski portfolios intact and to license them to NWBio.  In the immediate term, we will continue to focus intensively on pursuing the approval and commercialization of DCVax^®-L for glioblastoma, but we are excited to begin working on growth opportunities with the licensed technologies as well."

The terms of the Roswell license include standard provisions for an upfront license fee and milestones related to the first Phase 2 trial, first Phase 3 trial, first product approval and first commercial sale.  If all of the milestones are met, the payments would be approximately $2.3 million.  The license terms also include royalties of 4% on product sales (potentially reduced to 3% in the event of royalty stacking).

About Northwest Biotherapeutics

Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products that are designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis.  The Company has a broad platform technology for DCVax^® dendritic cell-based vaccines. The Company's lead program involves DCVax^®-L treatment for glioblastoma (GBM).  GBM is the most aggressive and lethal form of primary brain cancer, and is an "orphan disease."  The Company has completed a 331-patient Phase III trial of DCVax-L for GBM, presented the results in scientific meetings, published the results in JAMA Oncology and submitted a MAA for commercial approval in the UK.   The Company has also developed DCVax^®-Direct for inoperable solid tumor cancers.  It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials.  The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.

Disclaimer

Statements made in this news release that are not historical facts, including statements concerning plans for DCVax 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, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected in any forward-looking statement. Readers should not rely upon forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those anticipated, including, without limitation, risks related to delays or uncertainties in regulatory processes and decisions, risks related to the Company's ability to achieve timely performance of third parties, risks related to whether the Company's products, including products involving in-licensed intellectual property, will be viewed as demonstrating safety and efficacy, risks relating to funding or implementation of clinical trials, including trials involving in-licensed intellectual property, risks related to the Company's ongoing ability to raise additional capital, and other risks included in the Company's Securities and Exchange Commission ("SEC") filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company's results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company's SEC filings that may cause actual plans, results or timelines to differ materially from those projected in any forward-looking statement. 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.

CONTACTS         

Northwest Biotherapeutics                                           

Dave Innes
804-513-6758
dinnes@nwbio.com   

Les Goldman
240-234-0059
lgoldman@nwbio.com

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SOURCE Northwest Biotherapeutics