Northwest Biotherapeutics Secures Exclusive License for Dendritic Cell Tech and IP

Northwest Biotherapeutics, Inc. (NW Bio), a biotechnology company focused on developing DCVax® immune therapies for solid tumor cancers, announced that it has secured an exclusive license from Roswell Park Comprehensive Cancer Center. This agreement, concluded on June 12, 2024, gives NW Bio access to a portfolio of dendritic cell technologies and intellectual property (IP) currently in Phase 2 clinical trials. The partnership will involve collaboration with Dr. Pawel Kalinski, the lead scientist, to further develop these technologies.

The license includes five patent families filed in 2023, ensuring a full patent life ahead. These technologies feature enhanced dendritic cells (DCs) and DC-based therapies, conditioning regimens to boost patient responses, and methods to reprogram the tumor microenvironment. The goal is to improve immune therapy efficacy and counteract resistance to checkpoint inhibitors.

The DC-based therapies involve versions with tumor antigens loaded into the DCs and those for intra-tumoral administration without pre-loading antigens. Two Phase 2 trials using these technologies have begun enrolling patients for different cancers, with a third trial pending. All trials are fully funded by grants and led by investigators, meaning NW Bio will not have to provide financial or operational support.

Over the years, NW Bio has been discreetly in-licensing various technologies and IP to build a strong portfolio in dendritic cell therapies. The Roswell Park portfolio complements an existing portfolio exclusively licensed last year from another institution. Combined, these portfolios represent over 20 years of work by Dr. Kalinski's team, involving foundational technologies and positive early-stage clinical trial results.

The portfolio licensed last year includes 17 years of research before moving to Roswell, while the recent license covers seven years of additional work at Roswell. NW Bio plans to collaborate with Dr. Kalinski on further clinical development of these combined technologies. NW Bio believes its experience in producing and delivering personalized living-cell DC-based therapies positions it well to accelerate the late-stage development of these technologies. The company’s 331-patient Phase 3 clinical trial is one of the largest of its kind, providing valuable "real world" experience through compassionate use treatments.

Linda Powers, CEO of NW Bio, expressed excitement about partnering with Dr. Kalinski, a leading expert in dendritic cell biology and therapies. Powers acknowledged the supportive role of various institutions in maintaining the integrity of the Kalinski portfolios and licensing them to NW Bio. While the immediate focus remains on obtaining approval and commercializing DCVax®-L for glioblastoma, the company is eager to explore growth opportunities with the newly licensed technologies.

The terms of the license include an upfront fee and milestone payments related to the first Phase 2 and Phase 3 trials, product approval, and commercial sales, potentially totaling around $2.3 million. Additionally, there will be royalties of 4% on product sales, which may reduce to 3% in the case of royalty stacking.

Northwest Biotherapeutics aims to develop personalized immunotherapy products for cancer treatment, minimizing the toxicity associated with traditional treatments like chemotherapy. Their leading program focuses on DCVax®-L for glioblastoma, the most aggressive form of primary brain cancer. The company has completed a 331-patient Phase III trial for this treatment and published the results in JAMA Oncology. NW Bio also has plans for further trials of DCVax®-Direct for inoperable solid tumors and has previously conducted trials for advanced ovarian cancer in collaboration with the University of Pennsylvania.